vantagebiotrials - Vantage Biotrials

Vantage BioTrials Joins AI Collaboration to Advance Clinical Trial Intelligence and Improve Trial Execution with TrialsBank™

vantagebiotrials — Thu, 23 Apr 2026 15:10:19 +0000

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

vantagebiotrials — Mon, 20 Apr 2026 14:52:02 +0000

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

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

vantagebiotrials — Wed, 01 Oct 2025 16:11:15 +0000

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

vantagebiotrials — Fri, 13 Jun 2025 16:10:58 +0000

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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Prioritizing Agility When Choosing a Contract Research Organization

vantagebiotrials — Sat, 23 Mar 2024 01:51:24 +0000

Prioritizing Agility When Choosing a Contract Research Organization

Publication date: September 2023 / Download PDF
Author: Josée Comeau

Introduction

Throughout the years, the field of clinical research has continued to grow in complexity and has encountered numerous challenges, and although processes have been well established, many of us have settled into a daily routine that maintains the status quo.

It’s time for us to move away from traditional practices and introduce a concept that some niche CROs, like Vantage BioTrials, have been utilizing effectively since the early days of the Covid-19 pandemic, namely using agile methodologies in running clinical trials.

There are many strategies to help with time management that are available in a PM’s toolbox, but if they were easy to implement, we as an industry wouldn’t still be struggling with it. Part of this struggle comes from the fact that humans and systems have the tendency to follow the easiest path of no resistance. For our brain, resistance is something that requires effort, and therefore it becomes relentless and demands time. A natural reaction is to ignore or postpone certain obstacles and focus on activities we are more familiar with. As a result, we end up wasting time and not meeting the expected project milestones.

Perspective

As per ClinicalTrials.gov, there is well over 64,000 recruiting studies that are “ongoing” in status. We started 2023 with approximately 437 000 registered studies as opposed to 137 000 in 2013 (which equates to a ~320% increase over a decade).¹ Have our resources grown to cover those needs? Not even close. As our workforce has been shaken by a pandemic, high turnover, new regulations and restrictive budgets for the past few years, resourcing and manpower challenges have exponentially grown as well.

To compensate, some have attempted to re-structure themselves and found more efficient ways to work but, in the last few years, for many of us, it hasn’t seemed enough to keep our head’s above water for the long haul. As we strive to achieve excellence in managing clinical trials, we need something more to accelerate our progress and conduct these studies in what we would sometimes refer to as a “smoother process” and gain efficiencies. It has become essential to bring in more experts who understand the intricacies of research and enhance process flows with agile frameworks.

Agility is Key

When it comes to effectively managing clinical trials, an agile methodology has become increasingly important in light of the challenges posed by high turnovers and low staffing. Bounded by communication breakdowns, delays in timelines, and other deviations that can negatively change the outcome of a clinical study, it’s clear that we need to find new and innovative ways to work more efficiently as we settle into a reality that brings forward long-term impacts. With the flexibility of an agile framework, we can adjust our goals and objectives in real time and keep up with the constantly evolving environment. This agility also means that we can make quick decisions based on available data and adjust our strategies accordingly. A solid risk-management plan should be prepared by the study team well in advance of the “first patient in” milestone, and continuously verified, analyzed, maintained and updated as the study progresses.

Agile management is all about being adaptable and flexible in your approach, and it can be especially useful in the context of managing and monitoring of clinical trials. As the pioneering software engineer, Barry Boehm once said, “Agile methods derive much of their agility by relying on the tacit knowledge embodied in the team, rather than writing down their knowledge in plans.” It also helps to break down large projects into smaller, more manageable tasks, so that teams can easily adjust to changes and challenges as they arise. An agile approach helps keep timelines on track and ensures that everyone remains focused on the study’s ultimate goals.

Be Empathic

Let us also switch gears for a moment and look at the current situation through the lens of clinical trial sites; in general, many sites have had to tighten their belts and over-stretch their resources in order to keep up with the demand of the sheer volume of trials being thrown at them from Sponsors, and this has led to many sites refusing to work with certain types of Sponsors or CROs, creating a further gap between the number of available sites to perform the required studies. Down the road, this can lead to entire clinical programs being cancelled due to lack of qualified sites required to perform them. To combat this negative trend, as an example, Vantage BioTrials has embedded a culture of cooperation and collaboration between our staff and the sites we manage, acting as ambassadors (not adversaries) when performing site management activities on behalf of our Sponsors. Part of that success stems from effective communication strategies between all stakeholders that results in leading through empathy in order to understand the needs of our sites and supporting them with additional training, occasional check-ins, and a supportive hand when required.

Think Outside the Box

A major lesson that the Covid-19 pandemic taught us is that with workforce shortages, sometimes we also must settle for who is available; this can create diluted knowledge but does not necessarily translate into failure. Vantage BioTrials’ experienced team can support your study by adapting to its needs with agility, analysing requirements for technology and automation, quickly adapting in order to streamline operations and ensure tasks are completed efficiently and effectively. It can lead to more accurate and consistent results and tremendous success for your projects.

Another significant challenge facing the scientific community is the environments in which we work, and the communication strategies we use.
Scientific research plays an enormous role in our daily lives, and we were lucky enough to see the power of teamwork pull together worldwide as we survived through the global pandemic. In that sense, the entire world was forced to become “agile” very quickly. It allowed us to prioritize our well-being with an adaptive and flexible work environment, but also keenly bringing to the surface other challenges already present.

Although the status of the “pandemic” officially ended a while ago, one of the most significant impacts it had on science is the way it forced us to reconsider our work environments. With so many people working remotely or taking time off due to illness, it has been challenging to keep science moving forward at its usual pace. As a result, many studies now face delayed timelines, and research data is being affected. As it is challenging to plan and prevent these issues, it is also crucial we move forward swiftly for the sake of scientific progress.

Even if remote working can bring many positive outcomes for productivity, the disruption in communications and the isolation from not being in the office are significant. Perhaps most concerning of all is the impact that mental health challenges are having on advancing research projects. The McKinsey & Company survey mentioned that more than half of Americans between the ages of 18 to 34 struggle with mental health issues, affecting their work performance when working from home. Distractions, isolation, and a lack of contact with colleagues can all contribute negatively, which is where strong communication strategies come into play.² Teams spread out across different locations or working remotely need to stay in touch and communicate effectively using tools like video conferencing, instant messaging, and other collaboration tools. By maintaining open lines of communication, teams can work together more effectively and ensure the research progresses smoothly. Maintaining proper communication can also be especially challenging for new employees who have yet to have the chance to build relationships with their coworkers and get a sense of the company culture. For them, it translates into less peer recognition and less acknowledgment of the company’s values. Their roles are often unclear due to the nature of the communications, and the distractions from home can be difficult to overcome and impacts productivity.

Final Thoughts

Keeping a team motivated and on track can be challenging, let alone transferring knowledge and work competencies with a lack of fluidity between internal groups. Clear communication is vital for the success of any scientific or business venture, and the pandemic put that to the test. It is crucial to also prioritize flexibility and agility when planning clinical trials. This means being open to changes in our approach and being willing to adapt as necessary to ensure the research stays on track. This is when risk-based management and monitoring becomes crucial as a skill and as a tool. By being prepared for unexpected events and ready to shift gears when necessary, teams can better manage the trials and ensure that they successfully reach their goals. By prioritizing open communication, breaking down larger projects into manageable tasks, and staying adaptable in the face of challenges, teams can navigate the complex world of clinical trials and ultimately achieve success.

Moreover, partnering with a strategic niche CRO like Vantage BioTrials can be a game-changer when meeting goals and objectives. Experienced CROs bring a wealth of knowledge, resources, and expertise to the table, which can help to fill any skill gaps within the team. A niche CRO can also provide valuable insights into potential roadblocks or issues that may arise, allowing sites to plan proactively and avoid any possible delays or failures.
The pandemic has shown us how capable we are of adapting to new circumstances and coming together as a team to solve problems. We must continue to prioritize clear communication, efficient workflows, and a solid commitment to our shared mission of advancing knowledge and improving people’s lives. Only then will we overcome these challenges and emerge stronger on the other side!

About Vantage BioTrials

Vantage BioTrials is a leading Canadian Contract Research Organization (CRO) with a proven track record of successfully completing & delivering clinical trial milestones on time and on budget. Since our inception in 2007, we have used 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, based on the principles of Quality by Design and Risk-based clinical trial management.

References:

¹ https://www.clinicaltrials.gov/ct2/resources/trends

² https://www.mckinsey.com/industries/real-estate/our-insights/americans-are-embracing-flexible-work-and-they-want-more-of-it

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Criteria for Choosing a Great Contract Research Organization (CRO)

vantagebiotrials — Thu, 01 Feb 2024 01:48:26 +0000

Criteria for Choosing a Great Contract Research Organization (CRO)

Publication date: February 2024 / Download PDF Author: Viken Bartekian

Introduction

Outsourcing is often a necessity within the health care industry. Many pharmaceutical, biotechnology and medical device companies rely on outsourcing to Contract Research Organizations (CROs) as part of their strategy to advance to the next stage of clinical trials. As a matter of perspective, the CRO market size is expected to grow by USD 63.35 billion from 2023 to 2028. North America is estimated to contribute 40% to the growth of the global market during the forecast period.¹ Fueling this growth often places a burden on decision makers to make informed decisions regarding which CRO to outsource their clinical trial to. So, what makes a CRO stand apart? Simple, five important factors need to be considered: 1) Quality 2) Efficiency 3) Adaptability and Flexibility 4) Knowledge 5) Size, Culture and Values

You will notice that I have not mentioned the all-important cost factor. Understanding that for many companies, cost is an essential consideration to getting their clinical trial off the ground, we would also have to conclude that time is an important extension of cost. Just as the saying “time is money”, the clinical trial process has many moving parts, and all those parts are based on one constant factor, which is time! The lowest cost can be an influential factor to choosing a CRO. However, it’s important to understand that many CROs also use this as a bait tactic, only to generate change orders post contract win because they didn’t plan or estimate the time needed adequately.

Quality

The word quality is defined as the standard of something as measured against other things of a similar kind, or the degree of excellence of something.

To quote William A. Foster, “Quality is never an accident. It is always the result of high intention, sincere effort, intelligent direction, and skillful execution.”

We like rephrasing this quote into “Quality is an attribute we should always strive to achieve”. For this reason, quality always remains at the forefront of every clinical trial that Vantage BioTrials manages. It is embedded in our systems, procedures, and policies; in the way we train, monitor, and manage clinical trials. As experts in our field, we continuously implement risk mitigation by using Quality by Design (QbD) methodologies (to read more about QbD, refer to our previous Whitepaper entitled “Quality by Design in Clinical Research”).²

Having a quality mindset isn’t only to concentrate on results that matter. It’s to ensure that all results matter.

Efficiency

The term efficiency can be defined as the ability to achieve an end goal with little to no waste, effort, or energy. Being efficient means you can achieve your results by putting the resources you have in the best way possible. Put simply, something is efficient if nothing is wasted, and all processes are optimized. In other words, you will have mastered efficiency when you’re using the least amount of input to get the highest amount of output.

As a CRO, identifying efficiencies early on is crucial for the success of any clinical trial. But how early is too early? To give you an example, Vantage BioTrials applies Risk-based Quality Management (RBQM) strategies during the initial Request for Proposal (RFP) stage. Thoroughly reviewing a protocol and challenging a Sponsor is part of our process which helps align realistic expectations. This in turn presents an opportunity to explore changes required in order to achieve the most successful outcome for a project.

In our experience, open & transparent discussions help build a solid foundation towards maintaining an efficient long-term partnership.

Adaptability & Flexibility

Change is a constant factor in everyone’s life. Humans are often averse to change; we like a routine. Adapting to constant change is sometimes a challenge during the best of times. We can only imagine, and some of us have even lived it, changing ourselves or our environment thorough the worst of times.

As a CRO, with increased competition and a shifting regulatory landscape, we are constantly faced with significant challenges that push us to find ways to differentiate our service offering and remain competitive. As a specialized CRO, Vantage BioTrials is able to quickly pivot and apply tools and technologies that continue to conform with regulatory requirements. We remain vigilant, make quick decisions, and ensure little or no disruption to our services.

How quickly do we adapt you may ask? During the COVID-19 pandemic, we shifted from on-site monitoring to remote monitoring overnight. Even after some of our employees were poached to larger competitors, we quickly on-boarded local consultants with which we’ve formed strong relationships over the years. We went from accepting on-site Sponsor audits to remote ones by adopting a Quality Management System software. We adopted and onboarded a robust CTMS system within a month to track real time metrics of any given project.

Similarly, continuing to remain flexible is vital. Granted that in certain cases, flexibility becomes challenging. For example, a client wants your CRA to go monitor on-site across the country at the 11th hour, knowing that there are circumstances that would not allow you to do so (e.g. snow storms, ongoing airport strikes, etc.). Flexibility does not mean you jump when asked to. Flexibility is the willingness to change or compromise. Therefore, being solutions oriented is a key driver to remaining flexible. If one cannot physically go and monitor, then suggest additional remote monitoring as an option until on-site monitoring is possible again. If required, provide a valid explanation in defense of your decision. Remember that compromise swings both ways.

Financial flexibility is also important and often a driving force in the decision-making process of start-up biotechnology and medical device companies. A pricing model that Vantage BioTrials has utilized repeatedly is the fixed fee model:

Not withstanding any amendments to the study design or protocol, this pricing model guarantees a set budget for the entirety of a project. It allows the tracking of projected vs. actualized amounts on a monthly basis. The benefits of this type of model includes:

Aligning incentives
Transparent budget visibility
No unexpected fee or charges
Shared accountability on commitments
Builds trust and deepens relationships

Lastly, it is important to remain focused in providing operational excellence throughout the management of clinical trials. With our proven track record, Vantage BioTrials has managed clinical trials in various therapeutic areas from the most complex (rare disease, oncology, pediatric, respiratory, infectious disease) to simple (consumer health) and has repeatedly demonstrated its ability to adapt and achieve all clinical trial milestones.

Knowledge

Knowledge is a fundamental criterion when it comes to any business. It isn’t regarding how much you know, but also how much you can educate others with your knowledge.

With over 19 worldwide regulators (Health Canada, FDA, EMA, ANVISA, TGA, etc.) and a countless number of guidelines and standards within these governing bodies, the healthcare industry is one of the most heavily regulated. The different types of knowledge bases become even more crucial; regulatory, medical/scientific, quality standards (data, monitoring, biostatistics, risk analysis), operational best practices, budgeting, and technical. Demonstrating this knowledge base through examples of personal experiences, expertise and case studies is an important element that can strengthen the qualities of a CRO. Maintaining a sound training program/matrix ensures your organization’s ability to perform clinical trials which can in-turn instill the Sponsor’s confidence in your ability to delivery quality results.

Size, Culture and Values

The size of a CRO can be misleading when shopping for one. In fact, small size CROs such as Vantage BioTrials have proven time and again that we can manage clinical trials as good, if not better, than the larger CROs. Don’t look further than our achievement in 2021 when we announced the successful management and completion of a Phase IV observational, multicentre, postmarketing study in adult patients with a clinical diagnosis of moderate-to-severe Hidradenitis suppurativa (HS), approximately 12 months in advance.³

In the history of clinical trials, no other CRO (large or small) has ever come close to achieving this type of milestone. The result of which includes many of the factors listed above, plus, one important factor: our pharmaceutical Sponsor decided to take a chance on us, not due to cost, but because of our lean business model, which presents a more intimate, closer relationship with their team. This in turn leads to faster execution, easier conversations, and a less robotic and more genuine experience that generates trust.

Trust is the most important criteria when looking for a CRO as Sponsors need to learn to “let go” from their project and trust their CRO just as you would trust the electrician you hired to rewire your home. This is mainly the reason why having too much specialization in one domain can be counter-productive to the relationship and speed of execution. Developing trust and allowing your CRO to deliver results on their own terms also allows for mistakes to happen, for everyone to learn and grow, and for the relationship to flourish into a long-term partnership. Clinical trials are run by humans. To err is human, and mistakes will happen, it’s inevitable. Allowing your peers the space to prove their worth fosters deep appreciation for one another.

Respectively, it is the CRO’s duty to communicate properly, give regular updates, share enthusiasm, as well as to be fully transparent and accountable when there are red flags and concerns, as communication is key to the overall success of the project. The values of both companies need to be mutual and shared, and the Sponsor must fully explain the overview of the project, delegate tasks accordingly and the CRO needs to make the Sponsor comfortable by creating solid plans of action showcasing their full engagement to the project.

Having a vision explained, shared, and understood, as well as having aligned values, increases the chances of having matching company cultures and strong long-term harmonious relationships.

Final Thoughts

As competition grows, some CROs continue to over promise their capabilities and underestimate (or low ball) their costs. Sponsors are faced with challenging decisions on who to outsource to or sometimes they maintain the status quo and avoid changing CROs altogether because it’s perceptively too much of a burden. Factors other than cost need to be considered when deciding who to partner with.

As large CROs continue to remain siloed, it is important to choose a CRO that continues to offer flexibility in its service offering and fits your purpose. The same level of service should be given regardless if you’re a small biotech, medical device, or a large pharmaceutical company.

Building a strong relationship of trust will allow shared vision, values, and culture, which in turn maximizes chances of study success – always maintaining a clear Vantage Point!

About Vantage BioTrials

References:

¹ https://www.prnewswire.com/news-releases/contract-research-organization-cro-market-size-to-grow-by-usd-63-35-billion-from-2023-2028–north-america-to-account-for-40-of-market-growth—technavio-302027963

² https://vantagebiotrials.com/quality-by-design-in-clinical-research/

³ https://vantagebiotrials.com/vantage-biotrials-successfully-manages-real-world-effectiveness-of-adalimumab-in-patients-with-moderate-to-severe-hidradenitis-suppurativa-the-1-year-solace-study/ Qualities of a Best-in-Class CRO

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Vantage BioTrials Awarded Phase 1b ARDS Trial

vantagebiotrials — Wed, 22 Nov 2023 19:59:48 +0000

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.

The post Vantage BioTrials Awarded Phase 1b ARDS Trial first appeared on Vantage Biotrials.

Prioritizing Agility When Choosing a Contract Research Organization

vantagebiotrials — Fri, 01 Sep 2023 01:54:53 +0000

Prioritizing Agility When Choosing a Contract Research Organization

Publication date: September 2023 / Download PDF
Author: Josée Comeau

Introduction

Perspective

As per ClinicalTrials.gov, there is well over 64,000 recruiting studies that are “ongoing” in status. We started 2023 with approximately 437 000 registered studies as opposed to 137 000 in 2013 (which equates to a ~320% increase over a decade).1 Have our resources grown to cover those needs? Not even close. As our workforce has been shaken by a pandemic, high turnover, new regulations and restrictive budgets for the past few years, resourcing and manpower challenges have exponentially grown as well.

Agility is Key

Be Empathic

Think Outside the Box

Even if remote working can bring many positive outcomes for productivity, the disruption in communications and the isolation from not being in the office are significant. Perhaps most concerning of all is the impact that mental health challenges are having on advancing research projects. The McKinsey & Company survey mentioned that more than half of Americans between the ages of 18 to 34 struggle with mental health issues, affecting their work performance when working from home. Distractions, isolation, and a lack of contact with colleagues can all contribute negatively, which is where strong communication strategies come into play.2 Teams spread out across different locations or working remotely need to stay in touch and communicate effectively using tools like video conferencing, instant messaging, and other collaboration tools. By maintaining open lines of communication, teams can work together more effectively and ensure the research progresses smoothly. Maintaining proper communication can also be especially challenging for new employees who have yet to have the chance to build relationships with their coworkers and get a sense of the company culture. For them, it translates into less peer recognition and less acknowledgment of the company’s values. Their roles are often unclear due to the nature of the communications, and the distractions from home can be difficult to overcome and impacts productivity.

Final Thoughts

About Vantage BioTrials

References:
1 https://www.clinicaltrials.gov/ct2/resources/trends
2 https://www.mckinsey.com/industries/real-estate/our-insights/americans-are-embracing-flexible-work-and-they-want-more-of-it

The post Prioritizing Agility When Choosing a Contract Research Organization first appeared on Vantage Biotrials.

President of Vantage BioTrials Interviewed by Pharmaboardroom on the State of Clinical Trials in Canada

vantagebiotrials — Sat, 26 Aug 2023 01:58:44 +0000

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.

The post President of Vantage BioTrials Interviewed by Pharmaboardroom on the State of Clinical Trials in Canada first appeared on Vantage Biotrials.

President of Vantage BioTrials Interviewed by CATALIS on the State of Clinical Trials Industry in Quebec During the COVID-19 Crisis

vantagebiotrials — Sat, 26 Aug 2023 01:56:08 +0000

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.