Regulatory Insights

  1. AI Maturity In Clinical Development 7/30/2025

    The future of clinical research relies on operationalizing AI in a scalable, sustainable manner, ensuring that both technological and human factors are harmonized in this transformative journey.

  2. Comply With The New NIH Transparency Rules For r/sNA Molecule Research 7/30/2025

    Review new transparency requirements for NIH-funded institutions engaged in research involving r/sNA molecules and regulations for Institutional Biosafety Committees (IBCs).

  3. Designing "Seamless Phase 1/2" Oncology Trials 7/25/2025

    Selecting a CRO with deep oncology expertise and seamless trial experience is vital to navigate these complexities and deliver transformative therapies to patients faster.

  4. Impact Of Data Concerns In Neurological Clinical Trials: Quality Matters 7/15/2025

    This is Part 1 of a 3-part series demonstrating how robust data analytics can address the real-world implications of data quality issues that affect patients waiting for effective treatments.

  5. Analytics–Powered Approach To Patient Recruitment Strategy 7/15/2025

    In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

  6. Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress 7/15/2025

    Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.

  7. Controlling Comment Chaos: A Medical Writing Leader's Story 7/14/2025

    Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.

  8. Strategies For QA Professionals In Life Sciences 7/14/2025

    Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

  9. Advancing Drug Safety: The Synergy Of Regulatory Affairs And Pharmacovigilance 7/14/2025

    Explore how pharmacovigilance and regulatory affairs teams work together throughout a product's lifecycle to monitor risks and keep vital safety information updated.

  10. The New Language Of E6 R3: What Makes The Guidelines So Different? 7/14/2025

    Unpack the significant changes in ICH E6 (R3), nearly a decade after its last update. This revision brings renewed focus to quality by design and digital provenance.