Downloads

31. Taking On Patient Recruitment From Another Angle — The Payer 5/28/2026

    Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment. 

32. Meeting The FDA's New Real-World Evidence Standards 5/27/2026

    FDA guidance is reshaping RWE strategy. Sponsors that build interoperable, audit-ready RWD infrastructure now will be best positioned for faster, defensible submissions.

33. The eCOA Iceberg 5/27/2026

    Understand the true cost of eCOA deployment, beyond software licenses, to reduce protocol risk, avoid operational bottlenecks, and protect study timelines and data quality.

34. ICH E6(R3) Is Here: How Should You Handle It? 5/27/2026

    Prepare for ICH E6(R3) with integrated oversight, audit-ready data, and streamlined trial operations designed to reduce burden, accelerate timelines, and support compliance.

35. Navigating The Challenges Of Large, International Phase III Breast Cancer Trials 5/27/2026

    In the competitive landscape of breast cancer research, aligning biomarker testing, regulatory pathways, and regional operations from day one creates a path to faster enrollment and stronger outcomes.

36. Protocol Flexibility Is A Quality Strategy 5/27/2026

    Anna-Zeralda Canals Hamann shares how flexible IRT design can help sponsors prepare for changes in supply strategy, dosing, and patient cohorts. Effective RTSM systems are designed to manage uncertainty without disrupting trial operations.

37. Real-Time RTSM Integration Monitoring For Sponsors 5/27/2026

    Real-time RTSM integration monitoring gives sponsors greater visibility, control, and confidence. Explore a platform that enables teams to manage the operational risks caused by this integration.

38. Data Management Without The Coordination Friction 5/27/2026

    Simplify clinical data management with one connected platform and an expert team delivering faster study startup, cleaner data, fixed-fee predictability, and fewer operational delays.

39. Support For Efficient FDA Interactions 5/27/2026

    In today’s regulatory climate, ongoing discussion about FDA workload, funding constraints, and shifting review priorities have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At Veristat, our most recent interactions reflect continued responsiveness and constructive engagement from FDA.

40. De-Risking The Neurology IND: Lessons From Early FDA Engagement 5/27/2026

    Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.