news-pressroom-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-pressroom-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.  

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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.

 

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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.

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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.

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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.

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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.

 

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Vantage BioTrials Awarded Phase 1b ARDS Trial https://vantagebiotrials.com/fr/vantage-biotrials-awarded-phase-1b-ards-trial/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-awarded-phase-1b-ards-trial Wed, 22 Nov 2023 19:59:48 +0000 https://staging.vantagebiotrials.com/?p=1314 November 1, 2023, Montréal, Canada – Vantage BioTrials, a full-service Contract Research Organization (CRO), has partnered with a US-based biotech to lead all clinical trial management activities of their Phase Ib Dose Escalation followed by Phase II randomized, placebo controlled, blinded end-point trial in patients with Acute Respiratory Distress Syndrome (ARDS), including COVID-19 patients. The dose escalation phase of the study will inform the safety profile of the Sponsor’s Investigational Product (IP) prior to an evaluation in patients at risk for mechanical ventilation in the dose expansion phase. Overall, the study will establish dosing guidelines for a larger study in acutely ill, hypoxemic patients with ARDS. “We are again excited to contribute our expertise towards this important initiative for the advancement of effective therapies in patients affected with ARDS.  We look forward to making a positive impact and achieving all study milestones for our US biotech Sponsor”, said Vatche Bartekian, President of Vantage BioTrials. “We are continually challenging ourselves by providing quality outcomes and strengthening our partnerships with leading North American hospitals. Most importantly, we continue to ensure the safety and well-being of patients with respiratory distress through our quality by design and risk-based approach to managing these types of challenging clinical trials”, added Mr. Bartekian. About Vantage BioTrials Vantage BioTrials is a Contract Research Organization (CRO) 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. Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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November 1, 2023, Montréal, Canada – Vantage BioTrials, a full-service Contract Research Organization (CRO), has partnered with a US-based biotech to lead all clinical trial management activities of their Phase Ib Dose Escalation followed by Phase II randomized, placebo controlled, blinded end-point trial in patients with Acute Respiratory Distress Syndrome (ARDS), including COVID-19 patients.

The dose escalation phase of the study will inform the safety profile of the Sponsor’s Investigational Product (IP) prior to an evaluation in patients at risk for mechanical ventilation in the dose expansion phase. Overall, the study will establish dosing guidelines for a larger study in acutely ill, hypoxemic patients with ARDS.

“We are again excited to contribute our expertise towards this important initiative for the advancement of effective therapies in patients affected with ARDS.  We look forward to making a positive impact and achieving all study milestones for our US biotech Sponsor”, said Vatche Bartekian, President of Vantage BioTrials. “We are continually challenging ourselves by providing quality outcomes and strengthening our partnerships with leading North American hospitals. Most importantly, we continue to ensure the safety and well-being of patients with respiratory distress through our quality by design and risk-based approach to managing these types of challenging clinical trials”, added Mr. Bartekian.

About Vantage BioTrials

Vantage BioTrials is a Contract Research Organization (CRO) 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.

Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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President of Vantage BioTrials Interviewed by Pharmaboardroom on the State of Clinical Trials in Canada https://vantagebiotrials.com/fr/president-of-vantage-biotrials-interviewed-by-pharmaboardroom-on-the-state-of-clinical-trials-in-canada/?utm_source=rss&utm_medium=rss&utm_campaign=president-of-vantage-biotrials-interviewed-by-pharmaboardroom-on-the-state-of-clinical-trials-in-canada Sat, 26 Aug 2023 01:58:44 +0000 https://staging.vantagebiotrials.com/?p=676 Vantage BioTrials’ President, Vatche Bartekian, was recently interviewed by Pharmaboardroom on ways that the company focuses on operational excellence with a lean and holistic approach to each project and how they continually advocate for greater visibility for Canada on the international stage and an increase in collaboration within the pharmaceutical industry and regulatory bodies. “What we can observe in Canada is a very diverse CRO landscape, in which each player has found its own specialty.” In this in depth interview with Bartekian, you will discover how Vantage BioTrials differentiates itself with its business model from other CROs, some of the the challenges facing CROs as well as advantages in conducting clinical trials in Canada, the company’s approach to team management and leadership and the evolution of leadership roles within the Canadian life sciences ecosystem. To read more about this compelling interview please click here. About us Founded in 2007, Vantage BioTrials is a privately-held Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services and implements Risk-Based Management through the use of Quality by Design (QbD) methodologies, all delivered to international pharmaceutical, biotechnology, generic pharmaceutical and medical device companies.

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Vantage BioTrials’ President, Vatche Bartekian, was recently interviewed by Pharmaboardroom on ways that the company focuses on operational excellence with a lean and holistic approach to each project and how they continually advocate for greater visibility for Canada on the international stage and an increase in collaboration within the pharmaceutical industry and regulatory bodies.

“What we can observe in Canada is a very diverse CRO landscape, in which each player has found its own specialty.”

In this in depth interview with Bartekian, you will discover how Vantage BioTrials differentiates itself with its business model from other CROs, some of the the challenges facing CROs as well as advantages in conducting clinical trials in Canada, the company’s approach to team management and leadership and the evolution of leadership roles within the Canadian life sciences ecosystem.

To read more about this compelling interview please click here.

About us

Founded in 2007, Vantage BioTrials is a privately-held Contract Research Organization (CRO) that provides Phase I-IV clinical trial management services and implements Risk-Based Management through the use of Quality by Design (QbD) methodologies, all delivered to international pharmaceutical, biotechnology, generic pharmaceutical and medical device companies.

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President of Vantage BioTrials Interviewed by CATALIS on the State of Clinical Trials Industry in Quebec During the COVID-19 Crisis https://vantagebiotrials.com/fr/president-of-vantage-biotrials-interviewed-by-catalis-on-the-state-of-clinical-trials-industry-in-quebec-during-the-covid-19-crisis/?utm_source=rss&utm_medium=rss&utm_campaign=president-of-vantage-biotrials-interviewed-by-catalis-on-the-state-of-clinical-trials-industry-in-quebec-during-the-covid-19-crisis Sat, 26 Aug 2023 01:56:08 +0000 https://staging.vantagebiotrials.com/?p=670 The future of clinical research after COVID-19 How will this crisis affect the clinical trial industry in Quebec? Just like in other industries, this pandemic, unfortunately, had an immediate impact on the pharmaceutical industry and notably clinical trials. The multiple restrictions limiting physical interactions between people entails many challenges and a multitude of projects that have been curtailed, postponed or even canceled. In the past weeks, we have observed four major problems linked to the current crisis: Many obstacles stop patients from going to their medical appointments. Clinical monitors are not allowed to be physically present on-site. There is a lack of available/working site personnel, which results in the delay in site activations/initiations and recruitment of patients during clinical trials. Cancellation of peer-to-peer conferences and meetings greatly reduces the access to continuing education and the possibility of new collaborations. By reflecting on the situation we’re currently in, we had to react quickly and brainstorm different solutions in order to minimize disruptions to operations. Despite confinement, technology permits us to communicate efficiently. These technological tools can be utilized in order to limit the negative impacts caused by COVID-19. “Meetings and physical encounters between stakeholders should be replaced with virtual secure platforms” Companies have to adapt and encourage virtual meetings. Our pharmaceutical clients took time to put in place extra precautions and security measures in order to guarantee a safe method of communication of key data. Even if these initiatives take more planning and organization, they are beneficial and can reinforce relationships between parties. “We should identify methods to facilitate a system for transporting patients” We recommend for sites to implement a private transportation service in order to facilitate transportation for patients and to favor homecare healthcare services (e.g. drug administration under perfusion). In order to facilitate follow-ups with patients following drug administrations, it is our recommendation to sites and sponsors to implement follow up from home or to manage with tiers in order to accelerate activities by using surveillance tools at a distance such as telemedicine. Ethics committees are receptive to these types of modifications as they understand that this is necessary in order to guarantee access to healthcare services and clinical options concerning innovative therapies. The changes must be done carefully and the protocol amended accordingly in order to reflect the new procedure. “The lack of available/working site staff has to be countered by prioritizing central ethics committee reviews” Under-staffing also causes delays in review and approval by institutional local ethics committees.  In order to avoid delays to new or ongoing studies, some local ethics committees might be open to allow a switch to central ethics committee reviews, and this should obviously be discussed and documented beforehand with the site in question. In Quebec, we already have a process to facilitate the administrative management of multi-centric ethics committee reviews using the “Nagano” system. “Let’s be imaginative in order to organize collective virtual events” As many in-person conferences are now canceled or indefinitely postponed, numerous groups in our industry are planning to organize virtual events in order for us to keep moving forward and share our ideas. As the organizer of the annual “Canada Talks Pharma” conference, we are currently in the process of putting together smaller online events in the style of “webinars”, while making sure to keep our participants highly engaged. “The collaboration of all Quebec stakeholders in clinical research will allow us to overcome this crisis” With the help and guidance from regulatory agencies and by using some common sense, we should be able to closely collaborate in order to get through this crisis together and come out of it stronger. With other initiatives being realized by CATALIS, we are already in a better position in Quebec to access clinical sites in order to activate them quicker so that projects start more rapidly. About us Vantage BioTrials, Inc. 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 President of Vantage BioTrials Interviewed by CATALIS on the State of Clinical Trials Industry in Quebec During the COVID-19 Crisis first appeared on Vantage Biotrials.

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The future of clinical research after COVID-19

How will this crisis affect the clinical trial industry in Quebec?

Just like in other industries, this pandemic, unfortunately, had an immediate impact on the pharmaceutical industry and notably clinical trials. The multiple restrictions limiting physical interactions between people entails many challenges and a multitude of projects that have been curtailed, postponed or even canceled. In the past weeks, we have observed four major problems linked to the current crisis:

  • Many obstacles stop patients from going to their medical appointments.
  • Clinical monitors are not allowed to be physically present on-site.
  • There is a lack of available/working site personnel, which results in the delay in site activations/initiations and recruitment of patients during clinical trials.
  • Cancellation of peer-to-peer conferences and meetings greatly reduces the access to continuing education and the possibility of new collaborations.

By reflecting on the situation we’re currently in, we had to react quickly and brainstorm different solutions in order to minimize disruptions to operations. Despite confinement, technology permits us to communicate efficiently. These technological tools can be utilized in order to limit the negative impacts caused by COVID-19.

“Meetings and physical encounters between stakeholders should be replaced with virtual secure platforms” Companies have to adapt and encourage virtual meetings. Our pharmaceutical clients took time to put in place extra precautions and security measures in order to guarantee a safe method of communication of key data. Even if these initiatives take more planning and organization, they are beneficial and can reinforce relationships between parties.

“We should identify methods to facilitate a system for transporting patients” We recommend for sites to implement a private transportation service in order to facilitate transportation for patients and to favor homecare healthcare services (e.g. drug administration under perfusion).

In order to facilitate follow-ups with patients following drug administrations, it is our recommendation to sites and sponsors to implement follow up from home or to manage with tiers in order to accelerate activities by using surveillance tools at a distance such as telemedicine.

Ethics committees are receptive to these types of modifications as they understand that this is necessary in order to guarantee access to healthcare services and clinical options concerning innovative therapies. The changes must be done carefully and the protocol amended accordingly in order to reflect the new procedure.

“The lack of available/working site staff has to be countered by prioritizing central ethics committee reviews” Under-staffing also causes delays in review and approval by institutional local ethics committees.  In order to avoid delays to new or ongoing studies, some local ethics committees might be open to allow a switch to central ethics committee reviews, and this should obviously be discussed and documented beforehand with the site in question. In Quebec, we already have a process to facilitate the administrative management of multi-centric ethics committee reviews using the “Nagano” system.

“Let’s be imaginative in order to organize collective virtual events” As many in-person conferences are now canceled or indefinitely postponed, numerous groups in our industry are planning to organize virtual events in order for us to keep moving forward and share our ideas. As the organizer of the annual “Canada Talks Pharma” conference, we are currently in the process of putting together smaller online events in the style of “webinars”, while making sure to keep our participants highly engaged.

“The collaboration of all Quebec stakeholders in clinical research will allow us to overcome this crisis” With the help and guidance from regulatory agencies and by using some common sense, we should be able to closely collaborate in order to get through this crisis together and come out of it stronger. With other initiatives being realized by CATALIS, we are already in a better position in Quebec to access clinical sites in order to activate them quicker so that projects start more rapidly.

About us

Vantage BioTrials, Inc. 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 President of Vantage BioTrials Interviewed by CATALIS on the State of Clinical Trials Industry in Quebec During the COVID-19 Crisis first appeared on Vantage Biotrials.

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Vantage BioTrials Has Gone Virtual https://vantagebiotrials.com/fr/vantage-biotrials-has-gone-virtual-2/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-has-gone-virtual-2 Sat, 22 Apr 2023 19:59:02 +0000 https://staging.vantagebiotrials.com/?p=1311 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. Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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.

Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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

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Vantage BioTrials Is Now Using Smartsheet Clinical Trial Management System https://vantagebiotrials.com/fr/vantage-biotrials-is-now-using-smartsheet-clinical-trial-management-system-2/?utm_source=rss&utm_medium=rss&utm_campaign=vantage-biotrials-is-now-using-smartsheet-clinical-trial-management-system-2 Fri, 22 Jul 2022 19:58:21 +0000 https://staging.vantagebiotrials.com/?p=1309 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. Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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.

Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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

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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-2/?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-2 Sun, 22 Aug 2021 19:57:38 +0000 https://staging.vantagebiotrials.com/?p=1307   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 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  (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at  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  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. For more information about this article or to download the full PDF version, click here or read about it in JEADV (The Journal of the European Academy of Dermatology and Venereology) by visiting the Wiley Online Library.   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. Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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.

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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 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  (IHS4). A post hoc analysis further explored the HiSCR response by abscess and inflammatory nodule (AN) count at  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  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.

For more information about this article or to download the full PDF version, click here or read about it in JEADV (The Journal of the European Academy of Dermatology and Venereology) by visiting the Wiley Online Library.

 

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.

Contact us today at info@vantagebiotrials.com and discover how we can add value to your next clinical trial program.

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.

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