Regulatory Insights

  1. Why You Should Include SDOH In Clinical Trial Recruitment 1/28/2025

    Embrace a broader approach to diversity in clinical trials by addressing social determinants of health and designing inclusive studies that ensure equitable representation and access to all patients.

  2. The Future Of Clinical Trials: 2025 Outlook 1/27/2025

    Looking ahead to 2025, clinical trials will evolve with new technologies, regulatory shifts, and emerging therapies. Explore key trends shaping the future of the industry.

  3. Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs 1/23/2025

    Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

  4. Advancing Clinical Research In 2025: Meeting FDA Standards In DCT 1/22/2025

    Explore the key components of new FDA guidance on DCTs, including a focus on participant-centric designs and the use of Mobile Research Units (MRUs) to overcome geographic and technological barriers.

  5. Proving The Return On Investment For eRegulatory 1/22/2025

    A study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools... and then some.

  6. How Digital Innovation Can Inform RWE-Led Decision-Making 1/17/2025

    Real-world evidence (RWE) is changing how healthcare products are developed and marketed. Learn how digital innovations are helping companies leverage RWE to make better decisions.

  7. The Bumpy Road Ahead: Stakeholder Perspectives On EU HTAR 1/17/2025

    Experts convened at ISPOR Europe 2024 to discuss the upcoming EU Health Technology Assessment Regulation (EU HTAR), sharing insights and lessons learned from recent national reforms.

  8. Successful Regulatory Submission Via The Trifecta Of Awesomeness 1/17/2025

    Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

  9. What Does 2025 Hold For Pharma? 1/17/2025

    Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.

  10. Groundbreaking Rare Disease Drug Approval (OGSIVEO [nirogacestat]) 1/16/2025

    Strategic guidance helped SpringWorks Therapeutics, a biopharmaceutical company dedicated to advancing precision medicine, to refine their regulatory strategy for late-stage development.