Unlocking Technology:  The Advantages of a Tech-Savvy CRO for IVD and Device Trials

The clinical research landscape for in-vitro diagnostics (IVD) and medical devices is experiencing a rapid evolution driven by technological advancements.  The COVID-19 pandemic certainly spurred the development and integration of new technology platforms with necessity largely driving industry adoption. However, in the wake of the pandemic, many sponsors are not realizing the full potential of the latest advances to improve the management and execution of their clinical research programs.

Bill Trembley - Senior Vice President, Chief Technology Officer
Authored by: Bill Trembley
Senior Vice President, Chief Technology Officer

As a forward-thinking Contract Research Organization (CRO), Beaufort has maintained momentum and continues to apply best-of-breed technology solutions that deliver measurable benefits for sponsors, sites, and patients. This technology focus has allowed our clients the ability to leverage our expertise and apply these innovations to streamline processes, enhance data quality, ensure regulatory compliance, and, ultimately, simplify and accelerate the development of ground-breaking products.

Optimizing the IVD and Medical Device Trial Journey with Technology

There are a wide variety of systems and tools that can help optimize operations within the clinical research paradigm and offer time and cost savings for sponsors.

The Power of Partnership: Why Technical Experience Matters

Applying a holistic and platform-agnostic view ensures access to the best-fit solutions for each specific IVD or medical device trial

A CRO’s established relationships with a wide variety of platform providers offer a significant advantage for sponsor programs. Applying a holistic and platform-agnostic view ensures access to the best-fit solutions for each specific IVD or medical device trial, considering factors such as device compatibility, regulatory compliance, and integration capabilities.

Beaufort’s team has considerable experience in evaluating and utilizing the latest technology solutions. We bring a deep understanding of the strengths and value of leading platforms and can provide seamless integration and ongoing support, maximizing efficiencies and minimizing disruption for study teams.

Navigating the Evolving Regulatory Landscape and Addressing Emerging Challenges

The regulatory landscape for IVD and medical devices has also been evolving to address guidance issues as it relates to cybersecurity and technology. It is critical for a CRO to proactively monitor regulatory changes and ensure their technology stack remains compliant with the latest guidelines, such as the EU IVDR and the US FDA’s regulations for medical devices. Additionally, rapidly advancing fields like Artificial Intelligence (AI) hold exciting potential in areas like image analysis and clinical trial design, but also raise questions about validation, ethical considerations, and regulatory clarity. A proactive CRO, like Beaufort, actively engages with regulatory bodies and industry stakeholders to address these challenges and ensure trials remain compliant and ethically sound.

Choosing the Right Partner for Success

Selecting the right CRO is crucial for the success of IVD and medical device trials. Look for a partner with:

By partnering with a tech-savvy CRO like Beaufort that demonstrates these qualities, you gain a valuable extension of your team, equipped to drive efficiency, data quality, and ultimately, accelerate the development of innovative IVD and medical device solutions that improve patient care.

Contact us today to see how Beaufort applies technology to support your next clinical research project.

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