#419: Essential Strategies for CRO Success in Today's Clinical Landscape

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.

Key Timestamps

• 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.

Quotes

"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."

Takeaways

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...