Regulatory Insights

  1. Why Biotechs Should Leverage Australia's Clinical Research Ecosystem 3/28/2025

    With a proven track record across diverse therapeutic areas, Australia is a cost-effective option as well as a strategic ally for biotech firms.

  2. The New Era Of Medical Monitoring 3/28/2025

    Examine the transformative landscape of medical monitoring in clinical trials with an emphasis on the shift from conventional retrospective reviews to a proactive, risk-based methodology.

  3. Harnessing RWE For Effective External Control Arms In Clinical Trials 3/24/2025

    Real-world evidence (RWE) is transforming clinical trials by enabling the use of external control arms (ECAs), which serve as an alternative to traditional randomized control groups.

  4. What To Look For In An Oncology CRO 3/24/2025

    Learn seven of the critical factors for choosing an oncology-focused CRO that enable sponsors to identify partners aligning with their clinical research objectives.

  5. Navigating Regulatory And Privacy Updates In Clinical Trials 3/21/2025

    Explore how the guide for eRegulatory adoption in Canada provides resources to help stakeholders navigate these changes and enhance participant engagement and retention in clinical trials.

  6. Rare Disease R&D: Continued Growth Amid Challenges 3/21/2025

    The market for rare disease treatments continues to grow but it is not without its challenges, including small patient populations and a lack of existing research.

  7. How Healthy Is Your TMF? A Check-In Before An Inspection 3/18/2025

    Explore how proper oversight of the Trial Master File (TMF) prevents inspection findings. Regular reviews, heatmaps, and risk-based assessments help ensure TMF health, and readiness for regulatory inspections.

  8. Five Key Trends In CMC 3/18/2025

    CMC is evolving with digitalization, sustainability, supply chain resilience, post-merger integration, and personalized medicine.

  9. Three Key Takeaways: Best Practices In Environmental Monitoring 3/18/2025

    An Environmental Monitoring (EM) program ensures microbial and particulate control in sterile manufacturing. A conference in India covered EM design, data interpretation, contamination risks, and regulatory expectations.

  10. Effective Digital Engagement For Biopharma Companies 3/18/2025

    The NASP Podcast explores biopharma digital engagement, emphasizing strategic communication, data analytics, and best practices to enhance healthcare decision-maker engagement across a product’s lifecycle.