ICH E6(R3) and the Hidden Risk to Biospecimen Data.
In this sponsored episode, originally produced by Slope, CEO and Co-founder, Rust Felix, sits down with regulatory and legal expert Edye Edens to unpack a critical — and often overlooked — aspect of the newly updated ICH E6(R3) GCP guidelines: biospecimen data governance. With EMA enforcement beginning July 23, 2025, the conversation explores what the updated language says about biospecimens and data governance, where most sponsors fall short, and how to close compliance gaps. If your trial still relies on spreadsheets, disparate systems, and/or paper for managing your biospecimen data, this episode is required listening.
Key Takeaways
- Why biospecimen data now falls squarely under the scope of ICH E6(R3) — and what that means for your responsibilities as a sponsor.
- How to spot hidden compliance risks in your current biospecimen workflows — especially if you’re still using spreadsheets, disparate systems, and paper processes.
- Common misconceptions around system validation.
- How to assess whether your audit trails, access controls, and validation protocols for sample trackers and biospecimen data management systems meet the new expectations.
- The top risk trends emerging from real sponsor risk assessments — and how your operations might compare.
- Actionable steps sponsors can take now to get ahead of EMA enforcement starting July 23, 2025.
Meet the Speakers
Rust Felix
CEO and Co-founder, Slope
Rust Felix is the CEO and Co-founder of Slope, a company dedicated to empowering clinical trial stakeholders to ensure protocol adherence and regulatory compliance by providing full visibility and a traceable chain of custody throughout the sample journey. Felix’s leadership has been instrumental in Slope’s growth and innovation, focusing on reducing site burden, enhancing data quality, minimizing risk, and accelerating study timelines.
Edye Edens
Life Sciences Legal & Regulatory Expert, Kulkarni Law Firm
Edye Edens is a seasoned legal and compliance professional specializing in clinical research and life sciences. With a juris doctor from Indiana University and a master’s in international research ethics, she brings over 15 years of experience in research compliance, regulatory operations, and clinical trial oversight. She currently acts as senior attorney for the Kulkarni Law Firm, where she advises AMCs, sponsors, CROs, and research sites.
About Slope
Slope is a global provider of biospecimen lifecycle software, data, and services for clinical trials. With a focus on tech-enabling the full biospecimen lifecycle, Slope empowers sponsors to make informed decisions using high-quality, real-time sample data. Slope has supported thousands of complex, sample-intensive trials worldwide.
To learn more visit: https://www.slopeclinical.com/
