In this episode, host Etienne Nichols speaks with Greenlight Guru's Christine Wilbert, an expert in Electronic Data Capture (EDC) systems for Clinical Research Organizations (CROs). They discuss the critical factors CROs must consider when selecting an EDC solution. Christine highlights that the biggest mistake is a lack of due diligence and not planning for future needs beyond a single study. She emphasizes the importance of looking for a solution that can scale with a company's growth, from pilot studies to pivotal trials, and warns against hidden costs and inadequate post-sales support.

The conversation delves into what truly matters in an EDC platform, such as intuitive design, speed of implementation, and the ability to handle repeatable processes. Christine shares that while some vendors may offer "bells and whistles," the core value lies in a lean, efficient system tailored to medical device trials. They also touch on the importance of involving all stakeholders, including site users like clinicians and healthcare professionals, to ensure system adoption and maintain data integrity.

Finally, the discussion explores how an EDC system can help CROs win more business. Christine explains that having a scalable, pre-validated solution and a vendor that actively supports business development can be a significant advantage. They also cover the essential compliance features for global trials, such as FDA 21 CFR Part 11 and ISO 14155, and the growing role of hybrid and decentralized trials. Christine's final advice to CROs is to "do your due diligence" and select a solution that's a true partner for long-term success.

• 00:02:39 - Biggest mistakes CROs make when choosing an EDC.
• 00:03:00 - The importance of future planning and scalability.
• 00:04:40 - The value of post-sales support and avoiding hidden fees.
• 00:05:31 - Essential features versus "vendor noise" and unnecessary bells and whistles.
• 00:08:11 - The analogy of a "battleship" vs. a "ninja" in problem-solving.
• 00:09:13 - Identifying key stakeholders for successful EDC implementation.
• 00:11:17 - Challenges and strategies for engaging healthcare professionals.
• 00:13:31 - When to start looking for an EDC solution and the typical timeline.
• 00:15:44 - The onboarding process and what successful companies do in the first few months.
• 00:18:39 - How CROs can use an EDC solution to win more business.
• 00:20:52 - Global compliance considerations (FDA, EU MDR) for EDC platforms.
• 00:23:36 - Features CROs think they need but don't (e.g., QMS integration).
• 00:26:03 - Adapting to hybrid and decentralized trials.
• 00:27:22 - The key takeaway: do your due diligence and seek a true partner.

"I would say the biggest issue is lack of due diligence... they're not necessarily thinking down the line, 'how is this going to scale with this specific company that they're working with?'"

"The bitterness of poor quality remains long after the sweetness of low price is forgotten."

1. Prioritize Scalability and Long-Term Planning: Don't choose an EDC solution just for a single pilot study. Evaluate whether the platform can handle the complexity and size of pivotal and post-market studies to avoid costly transitions in the future.
2. Look for True Partnership, Not Just a Vendor: A successful relationship with an EDC provider goes beyond the initial sale. Seek a vendor with strong post-sales support and a willingness to collaborate on business development initiatives to help you win more sponsor business.
3. Ensure a User-Friendly Design for All Stakeholders: An EDC system is only as good as the data entered into it. Selecting an intuitive, easy-to-use platform is crucial for ensuring adoption by clinical operations teams, data managers, and, most importantly, site users like clinicians and healthcare professionals.
4. Confirm Global Compliance and Validation Capabilities: For CROs supporting a variety of trials, it is essential to select an EDC platform that is pre-validated and compliant with global regulations like FDA 21 CFR Part 11 and ISO 14155 for EU MDR.
5. Focus on Core Functionalities Over "Bells and Whistles": Many platforms offer features that look good but are rarely used. A lean, purpose-built solution with essential functionalities like remote data entry, ePRO (electronic Patient Reported Outcomes), and efficient reporting is often more valuable than a system overloaded with unnecessary features.

• ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice. This standard is referenced as a key compliance framework for medical device clinical trials, particularly in the European Union.
• FDA 21 CFR Part 11 - The part of the Code of Federal Regulations that sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
• Etienne Nichols's LinkedIn - https://www.linkedin.com/in/etiennenichols/

What is a Clinical Research Organization (CRO)?

A Clinical Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. Think of a CRO as a specialist that a medical device company hires to manage a clinical trial. They handle everything from designing the study and recruiting participants to collecting and analyzing data, allowing the device company to focus on its core business.

What is an Electronic Data Capture (EDC) system?

An Electronic Data Capture (EDC) system is a software platform used in clinical trials to collect, manage, and report patient data. Instead of using paper forms, researchers enter data directly into a secure electronic database. This makes the data easier to share, reduces errors, and speeds up the entire clinical trial process. It’s like moving from a paper filing system to a digital spreadsheet, but with built-in security and compliance features specifically for clinical research.

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This episode is brought to you by Greenlight Guru, the only MedTech-specific QMS & EDC solution. Greenlight Guru helps medical device companies and CROs streamline their entire product lifecycle and clinical trial processes. By providing a modern, purpose-built platform for both Quality Management Systems (QMS) and Electronic Data Capture (EDC), Greenlight Guru ensures you have the tools to manage your clinical data and maintain compliance from a single source of truth. To learn how Greenlight Guru can accelerate your journey, visit www.greenlight.guru.