Regulatory Insights

  1. Maximizing Efficiency: A Comprehensive Guide To Study Coordination Services 1/14/2025

    Explore the critical role of study coordinators, emphasizing their expertise, strategic contributions, and the value they add to clinical research.

  2. Debunking Myths And Uncovering The Truths About Quality 1/14/2025

    Explore this discussion about the myths and misconceptions surrounding quality and compliance.

  3. Turning Your Inspection Fears Into Actionable Readiness Steps 1/9/2025

    Inspection readiness is a vital component of achieving FDA approval for drugs and devices, yet even seasoned clinical research professionals can face challenges in navigating the evolving regulatory landscape.

  4. Successfully Managing The Transition From Research To Development 1/9/2025

    When transitioning from research to development it's important to thoroughly understand FDA requirements and engage the FDA early on, and create an efficient integrated development plan.

  5. Ensure Seamless Clinical Trial Transition Across Global Markets 1/8/2025

    If you want to increase speed and reduce costs while still procuring high-quality data for your clinical trial, consider the impact of launching an early-phase clinical trial in Australia.

  6. Importance Of Audit Trail Data In Clinical Research 1/7/2025

    What is an audit trail and how does it help Clinical Trials ensure high quality clinical trial data?

  7. Five Steps To Preparing For The Product Management Service (PMS) Of EMA's SPOR Program 1/2/2025

    EMA's Product Management Service (PMS) database is crucial for IDMP compliance in the EU. Prepare for PMS requirements with this 5-step checklist that helps ensure smooth data migration and compliance.

  8. Advanced Aseptic Filling Technology And Annex I Compliance 1/2/2025

    NIBRT's new isolator training facility in Dublin offers hands-on experience with advanced aseptic filling technology, addressing Annex 1 compliance and industry challenges in sterile drug manufacturing.

  9. PIPA Conference Explores The Key Role Of PV 1/2/2025

    The PIPA 2024 conference emphasized the importance of pharmacovigilance across the pharmaceutical industry, from mergers and acquisitions to clinical trials and health authority inspections.

  10. Understanding The Clinical Trial Process 12/30/2024

    This guide to clinical trials explores the regulatory approval, study startup, and trial processes essential for advancing medical innovation.