news-homepage-EN - Vantage Biotrials https://vantagebiotrials.com/fr Contract Research Organization (CRO) implementing Risk-Based Management through the use of Quality by Design (Qbd) methodologies. Thu, 23 Apr 2026 15:10:19 +0000 fr-CA hourly 1 https://wordpress.org/?v=7.1.3 https://vantagebiotrials.com/wp-content/uploads/2024/03/cropped-favicon-VBT-32x32.png news-homepage-EN - Vantage Biotrials https://vantagebiotrials.com/fr 32 32 Vantage BioTrials Joins AI Collaboration to Advance Clinical Trial Intelligence and Improve Trial Execution with TrialsBank™ https://vantagebiotrials.com/fr/vantage-biotrials-joins-ai-collaboration-to-advance-clinical-trial-intelligence-and-improve-trial-execution-with-trialsbank/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-joins-ai-collaboration-to-advance-clinical-trial-intelligence-and-improve-trial-execution-with-trialsbank Thu, 23 Apr 2026 15:10:19 +0000 https://vantagebiotrials.com/?p=4925   April 20, 2026, Montréal, Canada – Vantage BioTrials, a leading Canadian Contract Research Organization (CRO) specializing in clinical trial management services, is proud to announce its participation in a strategic scientific collaboration with Sorintellis, Université de Montréal, Université Laval and IVADO. The collaboration aims to advance a next-generation AI-powered clinical trial intelligence platform, TrialsBank™, designed to improve clinical trial execution, patient outcomes and operational performance across global development programs.   AI-Powered Clinical Trial Intelligence to Improve Execution and Reduce Risk As clinical trials become more complex, sponsors face increasing challenges related to clinical trial delays, data fragmentation and execution risk. While large volumes of data are generated, the ability to convert that data into actionable clinical insights remains limited. TrialsBank™ addresses this gap by creating a structured clinical trial intelligence layer that enables: Real-time analysis of clinical trial data and operational metrics Early identification of clinical trial risks and performance gaps Predictive insights to improve clinical study timelines and efficiency Standardized frameworks for risk-based clinical trial management This approach supports a transition from reactive trial management to proactive, intelligence-driven clinical operations.   Vantage BioTrials Strengthens Clinical Trial Execution Through AI and Risk-Based Oversight As a CRO focused on inspection-ready clinical trial execution, Vantage BioTrials contributes deep expertise in translating data-driven insights into operational performance and measurable outcomes. “Clinical trials do not fail due to a lack of data. They fail when risks are not identified early or managed effectively,” said Vatche Bartekian, President of Vantage BioTrials. “By integrating AI-powered intelligence with disciplined clinical trial execution, this collaboration has the potential to significantly improve study timelines, quality and overall success rates.” Vantage BioTrials will support the initiative through its capabilities in: Risk-based monitoring (RBM) and proactive risk mitigation Clinical trial project management and operational oversight Quality-by-Design (QbD) implementation Regulatory-aligned, inspection-ready clinical trial delivery “AI can generate insights, but clinical trial success ultimately depends on execution,” added Viken Bartekian, VP Corporate Development. “Our role is to ensure that these insights translate into aligned execution across sites, regions and programs, where performance is determined.”   Academic and AI Expertise Advancing Clinical Research Innovation The collaboration leverages advanced research capabilities from Université de Montréal, Université Laval and IVADO to support: Machine learning models for clinical trial optimization Data standardization for multi-study clinical programs Scalable AI frameworks for clinical research analytics Sorintellis leads the development of the TrialsBank™ platform, focusing on AI-driven solutions for clinical research and drug development.   What This Means for Sponsors and Clinical Development Programs For biotechnology and pharmaceutical companies, this collaboration introduces a new approach to clinical trial performance management, enabling: Improved clinical trial timelines and milestone predictability Reduced operational and regulatory risk Enhanced data-driven decision-making in clinical development Greater consistency in multi-site and global clinical trials This model aligns with evolving regulatory expectations, including ICH E6(R3), which emphasize risk-based quality management and continuous oversight throughout the clinical trial lifecycle.   About Vantage BioTrials Vantage BioTrials is a Canadian-owned Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to the pharmaceutical, biotechnology and medical device industries. Known for its personalized service model, strategic value and commitment to quality, Vantage BioTrials uses innovative clinical trial management strategies focused on patient safety and the acceleration of new therapies to market. We offer a complete and integrated suite of full-service solutions designed to deliver operational efficiency at a competitive value across the life sciences sector.   Forward-Looking Statements This press release contains forward-looking statements regarding the expected impact of AI-driven clinical trial intelligence and the TrialsBank™ platform. Actual results may vary based on technological, regulatory and operational factors.  

The post Vantage BioTrials Joins AI Collaboration to Advance Clinical Trial Intelligence and Improve Trial Execution with TrialsBank™ first appeared on Vantage Biotrials.

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April 20, 2026, Montréal, Canada – Vantage BioTrials, a leading Canadian Contract Research Organization (CRO) specializing in clinical trial management services, is proud to announce its participation in a strategic scientific collaboration with Sorintellis, Université de Montréal, Université Laval and IVADO.

The collaboration aims to advance a next-generation AI-powered clinical trial intelligence platform, TrialsBank™, designed to improve clinical trial execution, patient outcomes and operational performance across global development programs.

 

AI-Powered Clinical Trial Intelligence to Improve Execution and Reduce Risk

As clinical trials become more complex, sponsors face increasing challenges related to clinical trial delays, data fragmentation and execution risk. While large volumes of data are generated, the ability to convert that data into actionable clinical insights remains limited.

TrialsBank™ addresses this gap by creating a structured clinical trial intelligence layer that enables:

  • Real-time analysis of clinical trial data and operational metrics
  • Early identification of clinical trial risks and performance gaps
  • Predictive insights to improve clinical study timelines and efficiency
  • Standardized frameworks for risk-based clinical trial management

This approach supports a transition from reactive trial management to proactive, intelligence-driven clinical operations.

 

Vantage BioTrials Strengthens Clinical Trial Execution Through AI and Risk-Based Oversight

As a CRO focused on inspection-ready clinical trial execution, Vantage BioTrials contributes deep expertise in translating data-driven insights into operational performance and measurable outcomes.

“Clinical trials do not fail due to a lack of data. They fail when risks are not identified early or managed effectively,” said Vatche Bartekian, President of Vantage BioTrials. “By integrating AI-powered intelligence with disciplined clinical trial execution, this collaboration has the potential to significantly improve study timelines, quality and overall success rates.”

Vantage BioTrials will support the initiative through its capabilities in:

  • Risk-based monitoring (RBM) and proactive risk mitigation
  • Clinical trial project management and operational oversight
  • Quality-by-Design (QbD) implementation
  • Regulatory-aligned, inspection-ready clinical trial delivery

“AI can generate insights, but clinical trial success ultimately depends on execution,” added Viken Bartekian, VP Corporate Development. “Our role is to ensure that these insights translate into aligned execution across sites, regions and programs, where performance is determined.”

 

Academic and AI Expertise Advancing Clinical Research Innovation

The collaboration leverages advanced research capabilities from Université de Montréal, Université Laval and IVADO to support:

  • Machine learning models for clinical trial optimization
  • Data standardization for multi-study clinical programs
  • Scalable AI frameworks for clinical research analytics

Sorintellis leads the development of the TrialsBank™ platform, focusing on AI-driven solutions for clinical research and drug development.

 

What This Means for Sponsors and Clinical Development Programs

For biotechnology and pharmaceutical companies, this collaboration introduces a new approach to clinical trial performance management, enabling:

  • Improved clinical trial timelines and milestone predictability
  • Reduced operational and regulatory risk
  • Enhanced data-driven decision-making in clinical development
  • Greater consistency in multi-site and global clinical trials

This model aligns with evolving regulatory expectations, including ICH E6(R3), which emphasize risk-based quality management and continuous oversight throughout the clinical trial lifecycle.

 

About Vantage BioTrials

Vantage BioTrials is a Canadian-owned Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to the pharmaceutical, biotechnology and medical device industries. Known for its personalized service model, strategic value and commitment to quality, Vantage BioTrials uses innovative clinical trial management strategies focused on patient safety and the acceleration of new therapies to market. We offer a complete and integrated suite of full-service solutions designed to deliver operational efficiency at a competitive value across the life sciences sector.

 

Forward-Looking Statements

This press release contains forward-looking statements regarding the expected impact of AI-driven clinical trial intelligence and the TrialsBank™ platform. Actual results may vary based on technological, regulatory and operational factors.

 

The post Vantage BioTrials Joins AI Collaboration to Advance Clinical Trial Intelligence and Improve Trial Execution with TrialsBank™ first appeared on Vantage Biotrials.

]]> Vantage BioTrials Joins CanReview Partner Network to Support Faster Clinical Trial Start-Up in Canada https://vantagebiotrials.com/fr/vantage-biotrials-joins-canreview-partner-network-to-support-faster-clinical-trial-start-up-in-canada/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-joins-canreview-partner-network-to-support-faster-clinical-trial-start-up-in-canada Mon, 20 Apr 2026 14:52:02 +0000 https://vantagebiotrials.com/?p=4914   April 20, 2026, Montréal, Canada – Vantage BioTrials, a leading Canadian Contract Research Organization (CRO) specializing in clinical trial management services, is proud to support CanReview, a pan-Canadian collaboration supported by the Accelerating Clinical Trials (ACT) Consortium to build a broadly accessible, Canada-wide single research ethics review system that will enable all research sites participating in a multi-site clinical trial to undergo one ethics review, while ensuring the highest ethical standards. Collaborating with Research Ethics Boards, research teams, Indigenous community members, institutions and sponsors, patients and family partners, and many others, CanReview aims to enhance clinical trials efficiencies, increase Canada’s competitiveness, expand clinical trials to underserved, rural and remote locations, and promote equitable access to trial participation.   Supporting Faster, More Coordinated Clinical Trial Activation in Canada As a Canadian CRO specializing in full-service clinical trial management, Vantage BioTrials is aligned with national initiatives aimed at improving collaboration between sponsors, CROs, institutions and regulatory bodies. Through its participation in the CanReview partner network, Vantage BioTrials supports efforts to: Facilitate coordinated and harmonized REB submissions and approvals Enhance predictability in clinical trial start-up processes Strengthen Canada’s position as a competitive destination for global clinical trials   Aligned with Evolving Clinical Trial Regulatory and Operational Expectations With increasing complexity in clinical development, early-stage coordination between stakeholders has become critical to minimizing delays and ensuring efficient trial execution. Since its founding in 2007, Vantage BioTrials has focused on delivering disciplined clinical trial management, incorporating: Proactive operational oversight Risk-based quality management strategies Transparent communication across stakeholders Participation in CanReview reflects the organization’s continued commitment to working within the national Canadian clinical trial framework to support more efficient and coordinated study start-up.   Advancing Canada’s Clinical Research Ecosystem Canada continues to be recognized globally for its high-quality clinical research environment, strong regulatory framework and experienced clinical sites. Initiatives such as CanReview play an important role in ensuring that Canada remains competitive by improving the speed and coordination of trial activation. By aligning with these national efforts, Vantage BioTrials continues to support sponsors in navigating the Canadian clinical trial landscape with greater efficiency, predictability and operational excellence.   About Vantage BioTrials Vantage BioTrials is a Canadian-owned Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to the pharmaceutical, biotechnology and medical device industries. Known for its personalized service model, strategic value and commitment to quality, Vantage BioTrials uses innovative clinical trial management strategies focused on patient safety and the acceleration of new therapies to market. We offer a complete and integrated suite of full-service solutions designed to deliver operational efficiency at a competitive value across the life sciences sector.   About CanReview CanReview is a pan-Canadian collaboration supported by the Accelerating Clinical Trials (ACT) Consortium to enable single research ethics review for multi-site clinical trials conducted across Canada, while ensuring the highest ethical standards. Collaborating with Research Ethics Boards, research teams, Indigenous community members, institutions and sponsors, patients and family partners and others, we are developing a system to enhance efficiencies and increase Canada’s competitiveness, expand clinical trials to underserved, rural and remote locations, and promote equitable access to trial participation. Together, we are building a Canada-wide ethics review system that benefits all people in Canada.

The post Vantage BioTrials Joins CanReview Partner Network to Support Faster Clinical Trial Start-Up in Canada first appeared on Vantage Biotrials.

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April 20, 2026, Montréal, Canada – Vantage BioTrials, a leading Canadian Contract Research Organization (CRO) specializing in clinical trial management services, is proud to support CanReview, a pan-Canadian collaboration supported by the Accelerating Clinical Trials (ACT) Consortium to build a broadly accessible, Canada-wide single research ethics review system that will enable all research sites participating in a multi-site clinical trial to undergo one ethics review, while ensuring the highest ethical standards.

Collaborating with Research Ethics Boards, research teams, Indigenous community members, institutions and sponsors, patients and family partners, and many others, CanReview aims to enhance clinical trials efficiencies, increase Canada’s competitiveness, expand clinical trials to underserved, rural and remote locations, and promote equitable access to trial participation.

 

Supporting Faster, More Coordinated Clinical Trial Activation in Canada

As a Canadian CRO specializing in full-service clinical trial management, Vantage BioTrials is aligned with national initiatives aimed at improving collaboration between sponsors, CROs, institutions and regulatory bodies.

Through its participation in the CanReview partner network, Vantage BioTrials supports efforts to:

  • Facilitate coordinated and harmonized REB submissions and approvals
  • Enhance predictability in clinical trial start-up processes
  • Strengthen Canada’s position as a competitive destination for global clinical trials

 

Aligned with Evolving Clinical Trial Regulatory and Operational Expectations

With increasing complexity in clinical development, early-stage coordination between stakeholders has become critical to minimizing delays and ensuring efficient trial execution.

Since its founding in 2007, Vantage BioTrials has focused on delivering disciplined clinical trial management, incorporating:

  • Proactive operational oversight
  • Risk-based quality management strategies
  • Transparent communication across stakeholders

Participation in CanReview reflects the organization’s continued commitment to working within the national Canadian clinical trial framework to support more efficient and coordinated study start-up.

 

Advancing Canada’s Clinical Research Ecosystem

Canada continues to be recognized globally for its high-quality clinical research environment, strong regulatory framework and experienced clinical sites. Initiatives such as CanReview play an important role in ensuring that Canada remains competitive by improving the speed and coordination of trial activation.

By aligning with these national efforts, Vantage BioTrials continues to support sponsors in navigating the Canadian clinical trial landscape with greater efficiency, predictability and operational excellence.

 

About Vantage BioTrials

Vantage BioTrials is a Canadian-owned Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to the pharmaceutical, biotechnology and medical device industries. Known for its personalized service model, strategic value and commitment to quality, Vantage BioTrials uses innovative clinical trial management strategies focused on patient safety and the acceleration of new therapies to market. We offer a complete and integrated suite of full-service solutions designed to deliver operational efficiency at a competitive value across the life sciences sector.

 

About CanReview

CanReview is a pan-Canadian collaboration supported by the Accelerating Clinical Trials (ACT) Consortium to enable single research ethics review for multi-site clinical trials conducted across Canada, while ensuring the highest ethical standards. Collaborating with Research Ethics Boards, research teams, Indigenous community members, institutions and sponsors, patients and family partners and others, we are developing a system to enhance efficiencies and increase Canada’s competitiveness, expand clinical trials to underserved, rural and remote locations, and promote equitable access to trial participation. Together, we are building a Canada-wide ethics review system that benefits all people in Canada.

The post Vantage BioTrials Joins CanReview Partner Network to Support Faster Clinical Trial Start-Up in Canada first appeared on Vantage Biotrials.

]]> Vantage BioTrials Awarded Phase 3 Clinical Trial in Substance Use Disorder https://vantagebiotrials.com/fr/vantage-biotrials-awarded-phase-3-clinical-trial-in-substance-use-disorder/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-awarded-phase-3-clinical-trial-in-substance-use-disorder Wed, 01 Oct 2025 16:11:15 +0000 https://vantagebiotrials.com/?p=4108 October 1, 2025, Montréal, Canada – Vantage BioTrials, a leading Canadian Contract Research Organization (CRO) specializing in clinical trial management services, is proud to announce its award and upcoming role in managing a pivotal Phase III randomized, double-blind, placebo-controlled clinical trial in the field of Substance Use Disorder. The study, sponsored by a biopharmaceutical company, aims to evaluate the safety and efficacy of an investigational approach for improving clinical reliability in treatment and monitoring settings. Due to reasons of confidentiality, specific trial details and investigational methods are not being disclosed at this time. “We are honored to be chosen as the CRO partner for this important late-phase study,” said Vatche Bartekian, President of Vantage BioTrials. “Substance Use Disorder continues to pose a significant global health challenge. This trial aligns with our mission to support sponsors in conducting high-quality, risk-based, and patient-centric clinical research.” Vantage BioTrials will provide full-service clinical trial management including project oversight, site management, monitoring, data review, and quality assurance—leveraging its deep expertise in regulatory compliance and operational excellence. The trial has officially commenced, with patient enrollment scheduled to begin in November 2025. This award marks another important milestone in Vantage BioTrials’ growing portfolio of late-phase studies in CNS, addiction medicine, and behavioral health—demonstrating the company’s capability to manage complex, high-impact trials from start to finish.   About Vantage BioTrials Inc. Vantage BioTrials is a Canadian-owned Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to the pharmaceutical, biotechnology, and medical device industries. Known for its personalized service model, strategic value, and commitment to quality, Vantage BioTrials uses innovative clinical trial management strategies focused on patient safety and the acceleration of new therapies to market. We offer a complete and integrated suite of full-service solutions designed to deliver operational efficiency at a competitive value across the life sciences sector. For more information about this Press Release or Vantage BioTrials’ services and capabilities, please visit www.vantagebiotrials.com or email us at info@vantagebiotrials.com.

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October 1, 2025, Montréal, Canada – Vantage BioTrials, a leading Canadian Contract Research Organization (CRO) specializing in clinical trial management services, is proud to announce its award and upcoming role in managing a pivotal Phase III randomized, double-blind, placebo-controlled clinical trial in the field of Substance Use Disorder.

The study, sponsored by a biopharmaceutical company, aims to evaluate the safety and efficacy of an investigational approach for improving clinical reliability in treatment and monitoring settings. Due to reasons of confidentiality, specific trial details and investigational methods are not being disclosed at this time.

“We are honored to be chosen as the CRO partner for this important late-phase study,” said Vatche Bartekian, President of Vantage BioTrials. “Substance Use Disorder continues to pose a significant global health challenge. This trial aligns with our mission to support sponsors in conducting high-quality, risk-based, and patient-centric clinical research.”

Vantage BioTrials will provide full-service clinical trial management including project oversight, site management, monitoring, data review, and quality assurance—leveraging its deep expertise in regulatory compliance and operational excellence.

The trial has officially commenced, with patient enrollment scheduled to begin in November 2025.

This award marks another important milestone in Vantage BioTrials’ growing portfolio of late-phase studies in CNS, addiction medicine, and behavioral health—demonstrating the company’s capability to manage complex, high-impact trials from start to finish.

 

About Vantage BioTrials Inc.

Vantage BioTrials is a Canadian-owned Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to the pharmaceutical, biotechnology, and medical device industries. Known for its personalized service model, strategic value, and commitment to quality, Vantage BioTrials uses innovative clinical trial management strategies focused on patient safety and the acceleration of new therapies to market. We offer a complete and integrated suite of full-service solutions designed to deliver operational efficiency at a competitive value across the life sciences sector.

For more information about this Press Release or Vantage BioTrials’ services and capabilities, please visit www.vantagebiotrials.com or email us at info@vantagebiotrials.com.

The post Vantage BioTrials Awarded Phase 3 Clinical Trial in Substance Use Disorder first appeared on Vantage Biotrials.

]]> Vantage BioTrials Recognized as Finalist for the 2025 Partnership Award https://vantagebiotrials.com/fr/vantage-biotrials-recognized-as-finalist-for-the-2025-partnership-award/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-recognized-as-finalist-for-the-2025-partnership-award Fri, 13 Jun 2025 16:10:58 +0000 https://vantagebiotrials.com/?p=3259 June 11, 2025, Montréal, Canada – Vantage BioTrials is proud to announce that it has been named a finalist for the esteemed 2025 Partnership Award, a prestigious award recognizing outstanding collaborative projects within Quebec’s innovation ecosystem. This accolade celebrates the successful partnership between Vantage BioTrials, Groupe Sorintellis, and the Centre de Recherche Informatique de Montréal (CRIM), underscoring a shared commitment to advancing clinical research through innovation and excellence. The Partnership Award finalist status highlights the strength and impact of this strategic collaboration, which combines Vantage BioTrials’ expertise in clinical trial management with Groupe Sorintellis and CRIM’s cutting-edge technological capabilities. Together, they have developed innovative solutions that enhance the quality, efficiency, and risk management of clinical trials, ultimately accelerating the delivery of life-saving therapies to patients. At the core of this partnership lies Vantage BioTrials’ commitment to Quality by Design (QbD) and Risk-Based Management (RBM) principles. By integrating these methodologies, the team ensures that clinical trials are meticulously planned, monitored, and optimized from inception to completion, delivering robust data integrity and regulatory compliance while reducing costs and timelines. “We are truly honored to be recognized among such talented and visionary partners,” said Vatche Bartekian, President of Vantage BioTrials. “This nomination reflects not only the strength of our partnership but also our dedication to driving innovation in clinical research, supporting our clients’ goals, and ultimately improving patient outcomes.” As a finalist for the Partnership Award, Vantage BioTrials continues to demonstrate leadership within Quebec’s vibrant life sciences and technology sectors. The company looks forward to continuing its collaboration with Groupe Sorintellis and CRIM, contributing to a stronger, more innovative clinical research environment. About Vantage BioTrials Inc. Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety & advancing new therapies to market. We offer pharmaceutical, biotech & medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value. For more information about Vantage BioTrials’ services and capabilities, please visit www.vantagebiotrials.com.  

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June 11, 2025, Montréal, Canada – Vantage BioTrials is proud to announce that it has been named a finalist for the esteemed 2025 Partnership Award, a prestigious award recognizing outstanding collaborative projects within Quebec’s innovation ecosystem. This accolade celebrates the successful partnership between Vantage BioTrials, Groupe Sorintellis, and the Centre de Recherche Informatique de Montréal (CRIM), underscoring a shared commitment to advancing clinical research through innovation and excellence.

The Partnership Award finalist status highlights the strength and impact of this strategic collaboration, which combines Vantage BioTrials’ expertise in clinical trial management with Groupe Sorintellis and CRIM’s cutting-edge technological capabilities. Together, they have developed innovative solutions that enhance the quality, efficiency, and risk management of clinical trials, ultimately accelerating the delivery of life-saving therapies to patients.

At the core of this partnership lies Vantage BioTrials’ commitment to Quality by Design (QbD) and Risk-Based Management (RBM) principles. By integrating these methodologies, the team ensures that clinical trials are meticulously planned, monitored, and optimized from inception to completion, delivering robust data integrity and regulatory compliance while reducing costs and timelines.

“We are truly honored to be recognized among such talented and visionary partners,” said Vatche Bartekian, President of Vantage BioTrials. “This nomination reflects not only the strength of our partnership but also our dedication to driving innovation in clinical research, supporting our clients’ goals, and ultimately improving patient outcomes.”

As a finalist for the Partnership Award, Vantage BioTrials continues to demonstrate leadership within Quebec’s vibrant life sciences and technology sectors. The company looks forward to continuing its collaboration with Groupe Sorintellis and CRIM, contributing to a stronger, more innovative clinical research environment.

About Vantage BioTrials Inc.

Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety & advancing new therapies to market. We offer pharmaceutical, biotech & medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.

For more information about Vantage BioTrials’ services and capabilities, please visit www.vantagebiotrials.com.

 

The post Vantage BioTrials Recognized as Finalist for the 2025 Partnership Award first appeared on Vantage Biotrials.

]]> Vantage BioTrials Has Gone Virtual https://vantagebiotrials.com/fr/vantage-biotrials-has-gone-virtual/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-has-gone-virtual Tue, 22 Aug 2023 18:23:02 +0000 https://staging.vantagebiotrials.com/?p=200 April 24, 2023, Montréal, Canada – Long before the COVID-19 pandemic, Vantage BioTrials had established the need to virtualize and offer its employees flexibility by offering remote working conditions. As a niche CRO, we believe in making a difference by striving to find better ways to reduce our carbon footprint, be productive and more efficient. By going virtual, we are achieving the following benefits:   Reducing Waste and Carbon Footprint: We have digitized all SOPs and Policies and as a result have reduced the need to use paper, as well as the use of fossil fuels (e.g. transit to and from office) by over 95%. Audits of our systems and processes are always welcome and will be granted access via the utilization of a licensed secure platform, Digify. Productivity: Since the last several years, overall productivity has increased drastically compared to the previous in-office model. Performance: Creating stronger autonomy via location independence has caused employees to produce greater work results, whereby increasing the level of quality. Engagement: The combination of higher productivity and performance has created stronger engagement, or in other words, much lower absenteeism. Retention: The flexibility of working remotely has resulted in less turnover. What remains the same Vantage BioTrials will continue to deliver the same clinical trial management services it has provided since it’s inception in 2007 by supporting drug and medical device clinical development/research in a broad spectrum of therapeutic areas. You will continue to receive services from the same individuals you have come to trust. What will change Any current Agreements that have the operations office address listed under the section “Notices” may have to be amended or revised to reflect the registered office’s address. Face-to-face meetings will be conducted at Sponsor’s office location or at “flexible workspace” locations (e.g. WeWork, Regus, MetSpace, etc.) with whom Vantage BioTrials has already secured arrangements About Vantage BioTrials Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety & advancing new therapies to market. We offer pharmaceutical, biotech & medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value

The post Vantage BioTrials Has Gone Virtual first appeared on Vantage Biotrials.

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April 24, 2023, Montréal, Canada – Long before the COVID-19 pandemic, Vantage BioTrials had established the need to virtualize and offer its employees flexibility by offering remote working conditions. As a niche CRO, we believe in making a difference by striving to find better ways to reduce our carbon footprint, be productive and more efficient. By going virtual, we are achieving the following benefits:


  • Reducing Waste and Carbon Footprint: We have digitized all SOPs and Policies and as a result have reduced the need to use paper, as well as the use of fossil fuels (e.g. transit to and from office) by over 95%. Audits of our systems and processes are always welcome and will be granted access via the utilization of a licensed secure platform, Digify.
  • Productivity: Since the last several years, overall productivity has increased drastically compared to the previous in-office model.
  • Performance: Creating stronger autonomy via location independence has caused employees to produce greater work results, whereby increasing the level of quality.
  • Engagement: The combination of higher productivity and performance has created stronger engagement, or in other words, much lower absenteeism.
  • Retention: The flexibility of working remotely has resulted in less turnover.

What remains the same

  • Vantage BioTrials will continue to deliver the same clinical trial management services it has provided since it’s inception in 2007 by supporting drug and medical device clinical development/research in a broad spectrum of therapeutic areas.
  • You will continue to receive services from the same individuals you have come to trust.

What will change

  • Any current Agreements that have the operations office address listed under the section “Notices” may have to be amended or revised to reflect the registered office’s address.
  • Face-to-face meetings will be conducted at Sponsor’s office location or at “flexible workspace” locations (e.g. WeWork, Regus, MetSpace, etc.) with whom Vantage BioTrials has already secured arrangements

About Vantage BioTrials

Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety & advancing new therapies to market. We offer pharmaceutical, biotech & medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value

The post Vantage BioTrials Has Gone Virtual first appeared on Vantage Biotrials.

]]> Vantage BioTrials Is Now Using Smartsheet Clinical Trial Management System https://vantagebiotrials.com/fr/vantage-biotrials-is-now-using-smartsheet-clinical-trial-management-system/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-is-now-using-smartsheet-clinical-trial-management-system Tue, 22 Aug 2023 18:22:46 +0000 https://staging.vantagebiotrials.com/?p=198 July 18, 2022, Montréal, Canada – Vantage BioTrials, a full-service Contract Research Organization (CRO), has on-boarded a robust technology solution to manage its growing demand of early/late phase and medical device clinical trials. Accuracy, flexibility, and speed in obtaining real-time data are crucial. During the last couple of years of the Covid-19 pandemic, Vantage BioTrials remained focused in identifying areas of development that will add value to the overall maintenance, tracking and successful completion of clinical trial milestones. By implementing the usage of a CTMS like Smartsheet, Vantage BioTrials is able to implement a solution that facilitates quicker response times to an evolving clinical trial landscape. Evolving life sciences landscape requires availability of real-time data “Before the pandemic began in 2020, Vantage BioTrials was actively evaluating different CTMS vendors. During our careful evaluation process, it was imperative that we involve our different departments to identify a suitable supplier that would fit our business model, allow ease of use and meet the demanding needs of our Sponsors”, said Vatche Bartekian, President, Vantage BioTrials. “As a specialized CRO, Vantage BioTrials continues to remain focused in its growth and to set a precedence that we will continue to effectively compete in this ever-changing global life sciences market, and offer the quality and expertise required to run highly complicated clinical studies across all phases of development”, added Mr. Bartekian. About Vantage BioTrials Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety & advancing new therapies to market. We offer pharmaceutical, biotech & medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.

The post Vantage BioTrials Is Now Using Smartsheet Clinical Trial Management System first appeared on Vantage Biotrials.

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July 18, 2022, Montréal, Canada – Vantage BioTrials, a full-service Contract Research Organization (CRO), has on-boarded a robust technology solution to manage its growing demand of early/late phase and medical device clinical trials. Accuracy, flexibility, and speed in obtaining real-time data are crucial. During the last couple of years of the Covid-19 pandemic, Vantage BioTrials remained focused in identifying areas of development that will add value to the overall maintenance, tracking and successful completion of clinical trial milestones. By implementing the usage of a CTMS like Smartsheet, Vantage BioTrials is able to implement a solution that facilitates quicker response times to an evolving clinical trial landscape.

Evolving life sciences landscape requires availability of real-time data

“Before the pandemic began in 2020, Vantage BioTrials was actively evaluating different CTMS vendors. During our careful evaluation process, it was imperative that we involve our different departments to identify a suitable supplier that would fit our business model, allow ease of use and meet the demanding needs of our Sponsors”, said Vatche Bartekian, President, Vantage BioTrials. “As a specialized CRO, Vantage BioTrials continues to remain focused in its growth and to set a precedence that we will continue to effectively compete in this ever-changing global life sciences market, and offer the quality and expertise required to run highly complicated clinical studies across all phases of development”, added Mr. Bartekian.

About Vantage BioTrials

Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety & advancing new therapies to market. We offer pharmaceutical, biotech & medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.

The post Vantage BioTrials Is Now Using Smartsheet Clinical Trial Management System first appeared on Vantage Biotrials.

]]> Vantage BioTrials Successfully Manages Real-World Effectiveness of Adalimumab in Patients with Moderate-to-Severe Hidradenitis Suppurativa: the 1-Year SOLACE Study https://vantagebiotrials.com/fr/vantage-biotrials-successfully-manages-real-world-effectiveness-of-adalimumab-in-patients-with-moderate-to-severe-hidradenitis-suppurativa-the-1-year-solace-study/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-successfully-manages-real-world-effectiveness-of-adalimumab-in-patients-with-moderate-to-severe-hidradenitis-suppurativa-the-1-year-solace-study Tue, 22 Aug 2023 18:22:18 +0000 https://staging.vantagebiotrials.com/?p=196 August 30, 2021, Montréal, Canada – Vantage BioTrials, a full service Contract Research Organization (CRO), is proud to have successfully managed, and completed approximately 12 months in advance, a Phase IV observational, multicentre, postmarketing study in adult patients with a clinical diagnosis of moderate-to-severe Hidradenitis suppurativa (HS). The primary objective of this clinical trial was to measure real-world effectiveness of adalimumab in HS and to secondarily observe clinical </span>course of HS in the light of patients’ response. In SOLACE, adults with moderate-to-severe HS in need for change in ongoing therapy were treated with adalimumab for up to 52 weeks as per physician s medical practice. Treatment effectiveness was measured by ’Hidradenitis Suppurativa Clinical Response (HiSCR). Inflammatory nodules, abscesses and draining fistulas were counted, Hurley stage was assessed, and disease severity was rated using the International HS Severity Scoring System&nbsp; (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at&nbsp; baseline (low, medium and high) and gender. Spontaneously reported safety events were collected. From 23 Canadian centres, 69% of the 138 patients achieved HiSCR at week 24, which increased to 82% and 75% at week 52 in patients with medium and high AN counts, respectively. Gender (4 times the odds for female) and age&nbsp; at HS onset (5% decrease with each additional year) had an effect on achieving HiSCR. Treatment with adalimumab led to an important decrease in number of lesions in responders, with most gains observed in inflammatory nodules, more frequently in the lower body area of patients in the high AN count group. The IHS4 scores of responders were substantially lowered, with a larger decrease in patients of the high AN count group. No new safety signal was detected. Conclusions The effectiveness of adalimumab was maintained during this 1-year period, and an optimal gain was documented for patients with medium and high AN counts. These real-world data support a prompt treatment of HS patients and the use of IHS4 to monitor treatment. About Vantage BioTrials Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety &amp; advancing new therapies to market. We offer pharmaceutical, biotech &amp; medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.

The post Vantage BioTrials Successfully Manages Real-World Effectiveness of Adalimumab in Patients with Moderate-to-Severe Hidradenitis Suppurativa: the 1-Year SOLACE Study first appeared on Vantage Biotrials.

]]>

August 30, 2021, Montréal, Canada – Vantage BioTrials, a full service Contract Research Organization (CRO), is proud to have successfully managed, and completed approximately 12 months in advance, a Phase IV observational, multicentre, postmarketing study in adult patients with a clinical diagnosis of moderate-to-severe Hidradenitis suppurativa (HS).

The primary objective of this clinical trial was to measure real-world effectiveness of adalimumab in HS and to secondarily observe clinical </span>course of HS in the light of patients’ response.

In SOLACE, adults with moderate-to-severe HS in need for change in ongoing therapy were treated with adalimumab for up to 52 weeks as per physician s medical practice. Treatment effectiveness was measured by ’Hidradenitis Suppurativa Clinical Response (HiSCR). Inflammatory nodules, abscesses and draining fistulas were counted, Hurley stage was assessed, and disease severity was rated using the International HS Severity Scoring System&nbsp; (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at&nbsp; baseline (low, medium and high) and gender. Spontaneously reported safety events were collected.

From 23 Canadian centres, 69% of the 138 patients achieved HiSCR at week 24, which increased to 82% and 75% at week 52 in patients with medium and high AN counts, respectively. Gender (4 times the odds for female) and age&nbsp; at HS onset (5% decrease with each additional year) had an effect on achieving HiSCR. Treatment with adalimumab led to an important decrease in number of lesions in responders, with most gains observed in inflammatory nodules, more frequently in the lower body area of patients in the high AN count group. The IHS4 scores of responders were substantially lowered, with a larger decrease in patients of the high AN count group. No new safety signal was detected.

Conclusions

The effectiveness of adalimumab was maintained during this 1-year period, and an optimal gain was documented
for patients with medium and high AN counts. These real-world data support a prompt treatment of HS patients
and the use of IHS4 to monitor treatment.

About Vantage BioTrials

Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety &amp; advancing new therapies to market. We offer pharmaceutical, biotech &amp; medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.

The post Vantage BioTrials Successfully Manages Real-World Effectiveness of Adalimumab in Patients with Moderate-to-Severe Hidradenitis Suppurativa: the 1-Year SOLACE Study first appeared on Vantage Biotrials.

]]> COVID-19 Clinical Trial Managed by Vantage BioTrials Receives Green-Light from FDA to Proceed in the United States https://vantagebiotrials.com/fr/covid-19-clinical-trial-managed-by-vantage-biotrials-receives-green-light-from-fda-to-proceed-in-the-united-states/?utm_source=rss&utm_medium=rss&utm_campaign=covid-19-clinical-trial-managed-by-vantage-biotrials-receives-green-light-from-fda-to-proceed-in-the-united-states https://vantagebiotrials.com/fr/covid-19-clinical-trial-managed-by-vantage-biotrials-receives-green-light-from-fda-to-proceed-in-the-united-states/#respond Tue, 22 Aug 2023 18:22:00 +0000 https://staging.vantagebiotrials.com/?p=194 August 27, 2020, Montréal, Canada – Vantage BioTrials, a full service Contract Research Organization (CRO), has partnered with its biotech Sponsor, Laurent Pharmaceuticals, to lead all clinical trial management activities of their lead oral drug candidate LAU-7b in a multicentric Phase 2 placebo-controlled clinical trial (RESOLUTION) in patients with COVID-19. We are pleased to join Laurent Pharmaceuticals in announcing that approval has been received from the Food and Drug Administration (FDA) to start enrolling U.S. patients in RESOLUTION, a multicentric Phase 2 randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential treatment against COVID-19 disease.&nbsp; RESOLUTION, which is currently ongoing in Canada, will enroll approximately 200 hospitalized COVID-19 patients who will receive either LAU-7B or a placebo for a treatment duration of 14 days. “During these unprecedented times, we are excited to contribute our expertise towards this important initiative for the advancement of effective therapies in patients infected with the novel coronavirus.&nbsp; We look forward to making a positive impact and achieving all study milestones for Laurent Pharmaceuticals”, said Vatche Bartekian, President of Vantage BioTrials.  “Our goal and focus is to continue challenging ourselves by providing quality outcomes, strengthening our partnerships with leading North American hospitals who are fighting this devastating disease on the frontlines, and achieving positive clinical trial results. Most importantly, we continue to ensure the safety and well-being of COVID-19 patients through our quality by design and risk-based approach to managing these types of challenging clinical studies”, added Mr. Bartekian. LAU-7b which showed potent antiviral effects in-vitro against both SARS-CoV-2 and MERS-CoV coronaviruses, is also being developed for its unique inflammation-controlling properties by acting on the resolution phase of the inflammation process, a natural mechanism that keeps the body’s inflammatory response under control without inducing immune-suppression (a “pro-resolving” effect). The pro-resolving proprieties of LAU-7b are currently under evaluation in a Phase 2 study in Cystic Fibrosis (CF), aiming to treat the exaggerated inflammatory response that leads to irreversible lung damage in these patients. The RESOLUTION trial (Clinicaltrials.gov, #NCT04417257) follows the recommendations of the World Health Organization (WHO) Master Protocol for COVID-19 clinical studies.&nbsp; It will measure the patient health status on a 7-point ordinal scale to evaluate the disease progression and inform the primary and secondary endpoints of the study. The study will also measure the duration of hospitalization and improvement in quality of life. About Vantage BioTrials Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety &amp; advancing new therapies to market. We offer pharmaceutical, biotech &amp; medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value. About Laurent Pharmaceuticals Laurent Pharmaceuticals is a clinical stage biopharmaceutical company focusing on life-threatening inflammatory diseases that are inadequately addressed by current anti-inflammatory therapies. The company’s lead drug candidate, LAU-7b, is a unique, patent protected oral formulation of fenretinide, ideally applicable to a once-a-day low dose treatment regimen. LAU-7b has the potential to trigger the resolution phase of inflammation and is currently in a Phase 2 study involving adult patients with CF. Fenretinide also showed potent antiviral effects in vitro against SARS-CoV-2, and the company initiated a Phase 2 clinical trial with LAU-7b in hospitalized COVID-19 patients. Fenretinide is an investigational retinoid that has a well-documented safety profile established in more than 3,000 patients, in various indications. For more information, please visit <a href="”http://www.laurentpharma.com”">www.laurentpharma.com</a>. About SARS-COV-2 and COVID-19 Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). &nbsp;It was first identified in December 2019 in Wuhan, Hubei, China, and has resulted in an ongoing pandemic. According to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, as of August 26, 2020, more than 23 million cases have been reported across 188 countries and territories, resulting in more than 820,800 deaths

The post COVID-19 Clinical Trial Managed by Vantage BioTrials Receives Green-Light from FDA to Proceed in the United States first appeared on Vantage Biotrials.

]]>

August 27, 2020, Montréal, Canada – Vantage BioTrials, a full service Contract Research Organization (CRO), has partnered with its biotech Sponsor, Laurent Pharmaceuticals, to lead all clinical trial management activities of their lead oral drug candidate LAU-7b in a multicentric Phase 2 placebo-controlled clinical trial (RESOLUTION) in patients with COVID-19.

We are pleased to join Laurent Pharmaceuticals in announcing that approval has been received from the Food and Drug Administration (FDA) to start enrolling U.S. patients in RESOLUTION, a multicentric Phase 2 randomized placebo-controlled trial testing once-a-day oral LAU-7b as a potential treatment against COVID-19 disease.&nbsp; RESOLUTION, which is currently ongoing in Canada, will enroll approximately 200 hospitalized COVID-19 patients who will receive either LAU-7B or a placebo for a treatment duration of 14 days.

“During these unprecedented times, we are excited to contribute our expertise towards this important initiative for the advancement of effective therapies in patients infected with the novel coronavirus.&nbsp; We look forward to making a positive impact and achieving all study milestones for Laurent Pharmaceuticals”, said Vatche Bartekian, President of Vantage BioTrials.  “Our goal and focus is to continue challenging ourselves by providing quality outcomes, strengthening our partnerships with leading North American hospitals who are fighting this devastating disease on the frontlines, and achieving positive clinical trial results. Most importantly, we continue to ensure the safety and well-being of COVID-19 patients through our quality by design and risk-based approach to managing these types of challenging clinical studies”, added Mr. Bartekian.

LAU-7b which showed potent antiviral effects in-vitro against both SARS-CoV-2 and MERS-CoV coronaviruses, is also being developed for its unique inflammation-controlling properties by acting on the resolution phase of the inflammation process, a natural mechanism that keeps the body’s inflammatory response under control without inducing immune-suppression (a “pro-resolving” effect). The pro-resolving proprieties of LAU-7b are currently under evaluation in a Phase 2 study in Cystic Fibrosis (CF), aiming to treat the exaggerated inflammatory response that leads to irreversible lung damage in these patients.

The RESOLUTION trial (Clinicaltrials.gov, #NCT04417257) follows the recommendations of the World Health Organization (WHO) Master Protocol for COVID-19 clinical studies.&nbsp; It will measure the patient health status on a 7-point ordinal scale to evaluate the disease progression and inform the primary and secondary endpoints of the study. The study will also measure the duration of hospitalization and improvement in quality of life.

About Vantage BioTrials

Vantage BioTrials is a Contract Research Organization that uses innovative clinical trial management strategies for the life science industry with a focus on patient safety &amp; advancing new therapies to market. We offer pharmaceutical, biotech &amp; medical device companies a complete and integrated set of full service clinical trial management solutions at a competitive value.

About Laurent Pharmaceuticals

Laurent Pharmaceuticals is a clinical stage biopharmaceutical company focusing on life-threatening inflammatory diseases that are inadequately addressed by current anti-inflammatory therapies. The company’s lead drug candidate, LAU-7b, is a unique, patent protected oral formulation of fenretinide, ideally applicable to a once-a-day low dose treatment regimen. LAU-7b has the potential to trigger the resolution phase of inflammation and is currently in a Phase 2 study involving adult patients with CF. Fenretinide also showed potent antiviral effects in vitro against SARS-CoV-2, and the company initiated a Phase 2 clinical trial with LAU-7b in hospitalized COVID-19 patients. Fenretinide is an investigational retinoid that has a well-documented safety profile established in more than 3,000 patients, in various indications. For more information, please visit <a href="”http://www.laurentpharma.com”">www.laurentpharma.com</a>.

About SARS-COV-2 and COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). &nbsp;It was first identified in December 2019 in Wuhan, Hubei, China, and has resulted in an ongoing pandemic. According to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, as of August 26, 2020, more than 23 million cases have been reported across 188 countries and territories, resulting in more than 820,800 deaths

The post COVID-19 Clinical Trial Managed by Vantage BioTrials Receives Green-Light from FDA to Proceed in the United States first appeared on Vantage Biotrials.

]]> https://vantagebiotrials.com/fr/covid-19-clinical-trial-managed-by-vantage-biotrials-receives-green-light-from-fda-to-proceed-in-the-united-states/feed/ 0 Innovative Medicines Canada Interviews President of Vantage BioTrials about the Challenges of Conducting Clinical Trials during COVID-19 Pandemic https://vantagebiotrials.com/fr/innovative-medicines-canada-interviews-president-of-vantage-biotrials-about-the-challenges-of-conducting-clinical-trials-during-covid-19-pandemic/?utm_source=rss&utm_medium=rss&utm_campaign=innovative-medicines-canada-interviews-president-of-vantage-biotrials-about-the-challenges-of-conducting-clinical-trials-during-covid-19-pandemic Tue, 22 Aug 2023 18:21:28 +0000 https://staging.vantagebiotrials.com/?p=192 MONTREAL, May 20, 2020 –Vantage BioTrials, a member of IMC, is a full-service Contract Research Organization (CRO) based in Canada that provides Phase I-IV clinical trial management services to pharmaceutical, biotechnology and medical device companies. Amid the on-going COVID-19 pandemic, our President, Vatche Bartekian, was interviewed by IMC about the current crisis and provided some insights on how Vantage BioTrials is overcoming some of the challenges caused by COVID-19. Below is the detailed exchange of questions/answers: IMC: Is Vantage BioTrials leading any COVID-19 related research? We are excited to announce that we’ve just started planning a clinical study for a local Canadian biotechnology firm who is repurposing their current novel therapeutic product to fight against COVID-19 and actually change the impact and outcome of the disease.&nbsp; The study is currently in “start-up” phase and we’re anticipating recruiting our first patients in Canada and the U.S. very shortly.&nbsp; More details will be announced soon via newswire.&nbsp; In addition, we have been approached by several other life science firms and academic research institutes to run additional COVID-19 trials. IMC: How is the COVID-19 pandemic affecting the clinical trial industry in Canada? As soon as lock-downs were announced in March, we felt the immediate results.&nbsp; Our sites provided us with quick feedback that their trial participants were no longer willing or able to attend regular visits, and all-new study initiations were being placed on hold until further notice.&nbsp; For us, this resulted in at least one major international study being postponed indefinitely, and a few others delayed due to a sudden halt in patient enrollment.</em><br><br><em>We’ve immediately noticed the following challenges for patients participating in a trial; social distancing requirements, site access restrictions, travel limitations, interruptions to the supply of investigational products, and an increased strain on hospital resources.&nbsp; These challenges have led to difficulties in meeting trial-specified procedures, including following mandatory visits, and access to a laboratory or diagnostic testing.</em><br><br><em>It’s also been particularly difficult for oncology research participants.&nbsp; For many cancer patients, research represents hope, yet most understand that they are particularly vulnerable to COVID-19, are at increased risk of severe outcomes if they become infected. Oncology research is experiencing a hiatus at this time; trial participants have to be protected as much as possible, and this sometimes entails not enrolling them during the pandemic.&nbsp; We have therefore noticed a decrease in the number of new requests for non-Covid studies spanning all therapeutic areas.&nbsp; Whenever we do receive a new request for managing a non-Covid study, we perform a thorough feasibility and safety analysis with information on-hand, which then determines whether or not we should move forward in initiating the study during the pandemic. IMC: How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Canada in the long term? I believe the most positive result of this global pandemic and its effect on clinical trials is that technologies and services like virtual trials, remote monitoring, and home nursing/healthcare solutions are no longer just discussions. Instead, we are accelerating their use for almost every clinical trial that wants to continue providing support and safety to its patients. However, a big question remains, and the answer is highly dependent on the course of this novel virus in the next year or so: how long will it be before we find effective treatments/vaccines, and how can we best evaluate what the impact to clinical trials will be if none are found? Regardless of the answer, it’s obvious that a “new normal” is being established for the future of clinical research. As the situation continues to develop and expand across all regions, we need to keep a close eye on the regional number of active cases of the coronavirus spread in the country/state/province. The more active cases in a given region, the bigger the pressure on its healthcare system. This will have a direct negative effect on clinical trial uptake in hospitals and private clinics. We also need to remember that there’s a psychological effect and consequence behind an increased number of cases (or consequent “waves” of infection), as this makes people more scared to participate in any research which involves potential visits to healthcare facilities, especially for higher-risk patients with underlying conditions (e.g. cancer patients, those with auto-immune diseases, etc). Remote patient or at-home nursing visits are part of the future solution. We currently have about 50% of drugs that are biologics that require monitored infusions. I believe that home healthcare is a sector that will see an uptake, and home infusions are going to be an important part of that. Whether it’s measuring a patient’s vitals, drawing blood, or collecting data, it will need to be performed all remotely (which also presents interesting opportunities for the wearable device sector). Not to mention that we also have to figure out how to reliably ship clinical trial materials directly to patients and confirm that they received it We also need to contend with regional “stay at home” measures as consequent waves of new infections occur. The stricter the mandated quarantine, the fewer opportunities there are for conducting a clinical trial unless it is fully virtual. In either case, we have no doubt of the importance and necessity for clinical trials to advance novel therapies, and they must keep moving forward. It’s up to us as an industry to innovate, think outside the box, and adopt or implement novel solutions to this dynamic problem. After all, history has only shown us that major advancements and steps in innovation occur during crises like the one we’re currently facing. I’m confident that our life science partners, represented by the amazing members of Innovative Medicines Canada, will continue to step up to the challenge and lead the way! You can also find the full interview on the IMC website by clicking <a href="”http://innovativemedicines.ca/meet-experts-vatche-bartekian/”" target="”_blank”" rel="”noreferrer" noopener”> About us Vantage BioTrials is a leading Canadian Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to international biopharmaceutical, biotechnology, generic pharma, and medical device companies within North America and Europe. We are experts in implementing Risk-Based Management through the use of Quality by Design (QbD) methodologies, which helps accelerate the conduct of a study and reduces overall risk.

The post Innovative Medicines Canada Interviews President of Vantage BioTrials about the Challenges of Conducting Clinical Trials during COVID-19 Pandemic first appeared on Vantage Biotrials.

]]>

MONTREAL, May 20, 2020 –Vantage BioTrials, a member of IMC, is a full-service Contract Research Organization (CRO) based in Canada that provides Phase I-IV clinical trial management services to pharmaceutical, biotechnology and medical device companies.

Amid the on-going COVID-19 pandemic, our President, Vatche Bartekian, was interviewed by IMC about the current crisis and provided some insights on how Vantage BioTrials is overcoming some of the challenges caused by COVID-19.

Below is the detailed exchange of questions/answers:

IMC: Is Vantage BioTrials leading any COVID-19 related research?

We are excited to announce that we’ve just started planning a clinical study for a local Canadian biotechnology firm who is repurposing their current novel therapeutic product to fight against COVID-19 and actually change the impact and outcome of the disease.&nbsp; The study is currently in “start-up” phase and we’re anticipating recruiting our first patients in Canada and the U.S. very shortly.&nbsp; More details will be announced soon via newswire.&nbsp; In addition, we have been approached by several other life science firms and academic research institutes to run additional COVID-19 trials.

IMC: How is the COVID-19 pandemic affecting the clinical trial industry in Canada?

As soon as lock-downs were announced in March, we felt the immediate results.&nbsp; Our sites provided us with quick feedback that their trial participants were no longer willing or able to attend regular visits, and all-new study initiations were being placed on hold until further notice.&nbsp; For us, this resulted in at least one major international study being postponed indefinitely, and a few others delayed due to a sudden halt in patient enrollment.</em><br><br><em>We’ve immediately noticed the following challenges for patients participating in a trial; social distancing requirements, site access restrictions, travel limitations, interruptions to the supply of investigational products, and an increased strain on hospital resources.&nbsp; These challenges have led to difficulties in meeting trial-specified procedures, including following mandatory visits, and access to a laboratory or diagnostic testing.</em><br><br><em>It’s also been particularly difficult for oncology research participants.&nbsp; For many cancer patients, research represents hope, yet most understand that they are particularly vulnerable to COVID-19, are at increased risk of severe outcomes if they become infected. Oncology research is experiencing a hiatus at this time; trial participants have to be protected as much as possible, and this sometimes entails not enrolling them during the pandemic.&nbsp; We have therefore noticed a decrease in the number of new requests for non-Covid studies spanning all therapeutic areas.&nbsp; Whenever we do receive a new request for managing a non-Covid study, we perform a thorough feasibility and safety analysis with information on-hand, which then determines whether or not we should move forward in initiating the study during the pandemic.

IMC: How do you think the COVID-19 pandemic will alter current and future clinical research, both internationally and here in Canada in the long term?

I believe the most positive result of this global pandemic and its effect on clinical trials is that technologies and services like virtual trials, remote monitoring, and home nursing/healthcare solutions are no longer just discussions. Instead, we are accelerating their use for almost every clinical trial that wants to continue providing support and safety to its patients. However, a big question remains, and the answer is highly dependent on the course of this novel virus in the next year or so: how long will it be before we find effective treatments/vaccines, and how can we best evaluate what the impact to clinical trials will be if none are found? Regardless of the answer, it’s obvious that a “new normal” is being established for the future of clinical research.

As the situation continues to develop and expand across all regions, we need to keep a close eye on the regional number of active cases of the coronavirus spread in the country/state/province. The more active cases in a given region, the bigger the pressure on its healthcare system. This will have a direct negative effect on clinical trial uptake in hospitals and private clinics. We also need to remember that there’s a psychological effect and consequence behind an increased number of cases (or consequent “waves” of infection), as this makes people more scared to participate in any research which involves potential visits to healthcare facilities, especially for higher-risk patients with underlying conditions (e.g. cancer patients, those with auto-immune diseases, etc). Remote patient or at-home nursing visits are part of the future solution. We currently have about 50% of drugs that are biologics that require monitored infusions. I believe that home healthcare is a sector that will see an uptake, and home infusions are going to be an important part of that. Whether it’s measuring a patient’s vitals, drawing blood, or collecting data, it will need to be performed all remotely (which also presents interesting opportunities for the wearable device sector). Not to mention that we also have to figure out how to reliably ship clinical trial materials directly to patients and confirm that they received it

We also need to contend with regional “stay at home” measures as consequent waves of new infections occur. The stricter the mandated quarantine, the fewer opportunities there are for conducting a clinical trial unless it is fully virtual.

In either case, we have no doubt of the importance and necessity for clinical trials to advance novel therapies, and they must keep moving forward. It’s up to us as an industry to innovate, think outside the box, and adopt or implement novel solutions to this dynamic problem. After all, history has only shown us that major advancements and steps in innovation occur during crises like the one we’re currently facing. I’m confident that our life science partners, represented by the amazing members of Innovative Medicines Canada, will continue to step up to the challenge and lead the way!

You can also find the full interview on the IMC website by clicking <a href="”http://innovativemedicines.ca/meet-experts-vatche-bartekian/”" target="”_blank”" rel="”noreferrer" noopener”>

About us

Vantage BioTrials is a leading Canadian Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services to international biopharmaceutical, biotechnology, generic pharma, and medical device companies within North America and Europe. We are experts in implementing Risk-Based Management through the use of Quality by Design (QbD) methodologies, which helps accelerate the conduct of a study and reduces overall risk. 

The post Innovative Medicines Canada Interviews President of Vantage BioTrials about the Challenges of Conducting Clinical Trials during COVID-19 Pandemic first appeared on Vantage Biotrials.

]]> Vantage BioTrials Awarded “Excellence in Phase I-IV Clinical Trial Management Services” https://vantagebiotrials.com/fr/vantage-biotrials-awarded-excellence-in-phase-i-iv-clinical-trial-management-services/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-awarded-excellence-in-phase-i-iv-clinical-trial-management-services Mon, 21 Nov 2016 02:00:46 +0000 https://staging.vantagebiotrials.com/?p=682 November 21, 2016, Montréal, Canada – Vantage BioTrials has yet again been awarded for its passion and commitment in providing its clients and patients quality clinical trial management through the recognition of Corporate LiveWire Magazine in the category of Excellence in Phase I-IV Clinical Trial Management Services in their 2016 Healthcare and Life Sciences Award series. “After winning the International Life Sciences Award earlier this year, this new award was not anticipated but highly welcomed.  We are humbled to receive this recognition as it is a testament of our efforts leading up to our tenth year anniversary” said Viken Bartekian, Co-Founder and Vice-President of Corporate Development at Vantage BioTrials.  Bartekian continued to add, “Through our team’s hard work, passion and dedication, we are setting a precedence that small CRO’s such as Vantage BioTrials can compete in this ever growing global market and offer the quality and expertise to run highly complicated clinical studies across all phases of development.  We have expanded our capacity in the area of Post Market Observational Studies (PMOS) and Medical Device trials due to the changing and innovative healthcare landscape within Canada.  We look forward to working closely with our sponsors, partners and investigators in order to continue bringing safe and effective therapies to patients.”

The post Vantage BioTrials Awarded “Excellence in Phase I-IV Clinical Trial Management Services” first appeared on Vantage Biotrials.

]]> November 21, 2016, Montréal, Canada – Vantage BioTrials has yet again been awarded for its passion and commitment in providing its clients and patients quality clinical trial management through the recognition of Corporate LiveWire Magazine in the category of Excellence in Phase I-IV Clinical Trial Management Services in their 2016 Healthcare and Life Sciences Award series.

“After winning the International Life Sciences Award earlier this year, this new award was not anticipated but highly welcomed.  We are humbled to receive this recognition as it is a testament of our efforts leading up to our tenth year anniversary” said Viken Bartekian, Co-Founder and Vice-President of Corporate Development at Vantage BioTrials.  Bartekian continued to add, “Through our team’s hard work, passion and dedication, we are setting a precedence that small CRO’s such as Vantage BioTrials can compete in this ever growing global market and offer the quality and expertise to run highly complicated clinical studies across all phases of development.  We have expanded our capacity in the area of Post Market Observational Studies (PMOS) and Medical Device trials due to the changing and innovative healthcare landscape within Canada.  We look forward to working closely with our sponsors, partners and investigators in order to continue bringing safe and effective therapies to patients.”

The post Vantage BioTrials Awarded “Excellence in Phase I-IV Clinical Trial Management Services” first appeared on Vantage Biotrials.

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