Regulatory Insights

  1. Key Update On Guideline For Good Clinical Practice E6(R3) 4/21/2025

    Review details of the adoption of ICH GCP E6 R3 Principles and Annex 1, as well as what preparations and next steps your organization will need to undertake.

  2. Accelerating Clinical Data Review With Traceable Workflows 4/17/2025

    Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

  3. Tips For Navigating Tax Season As A 1099-MISC Recipient 4/16/2025

    Explore the tax implications for individuals who received compensation for participating in clinical trials, specifically focusing on the issuance of the 1099-MISC.

  4. Accelerate Your Oncology Breakthroughs 4/16/2025

    Finding the right partnership can help your oncology clinical trials overcome trial complexities through strategic planning, a deep scientific understanding, and operational excellence.

  5. A High-Touch, Patient-Centered Approach For Advancing Rare Disease Trials 4/15/2025

    On your journey to developing and executing a successful rare disease trial, it is critical to focus on patient experience and accessibility from the earliest stages of trial design.

  6. Global Trial Disclosure Landscape Grows Increasingly Complex 4/15/2025

    The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.

  7. Accelerate Respiratory Disease Trials: A Guide To Digital Endpoints 4/15/2025

    Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.

  8. Unlocking Continued Revenue And Growth From Established Products 4/14/2025

    Gain insights into how pharmaceutical companies successfully handle post-approval regulatory upkeep for established products, focusing on reducing operational costs and expanding global market access.

  9. Exploring Payer Coverage Of Anti-Obesity Medications 4/14/2025

    Understanding payer strategies for anti-obesity drugs is crucial. A recent study investigated commercial formulary trends, confirming cost as a major barrier despite positive patient outcomes.

  10. 5 Questions On Exploring Healthcare Decision-Maker Sentiments 4/14/2025

    Research presented at AMCP 2025 uses natural language processing on decision-maker feedback to predict coverage. Learn about the surprising findings and next steps in this Q&A.