Regulatory Insights

  1. Unpacking FDA's Final Rule To Regulate LDTs 3/14/2025

    Discover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.

  2. Navigating The FDA's Drug Supply Chain Security Act 3/14/2025

    Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.

  3. Navigating The Future Of Lab Developed Tests 3/14/2025

    Explore the pivotal role of lab-developed tests (LDTs) in medical diagnostics, their growing regulatory scrutiny, and their future trajectory in modern healthcare to advance patient care.

  4. Multi-Regional Clinical Trials: The Latest Guidance From FDA 3/12/2025

    Conducting multi-regional clinical trials (MRCTs) is essential for accelerating oncology drug development and ensuring broader patient access. However, differences across regions can impact findings.

  5. Helping Biotechs Overcome 4 Key Challenges 3/10/2025

    Delays in site payments, participant reimbursements, and logistical inefficiencies can create roadblocks for patients and sites.

  6. Navigating The Future Of Clinical Trials: Expert Insights For 2025 2/26/2025

    The biopharmaceutical industry is undergoing transformative changes to develop more dynamic and efficient frameworks that prioritize patient outcomes in 2025.

  7. Choosing The Right eClinRO Solution For Reliable Trial Data 2/21/2025

    Electronic clinician-reported outcomes (eClinROs) enhance the quality and consistency of clinical trial data. Discover key factors to consider when selecting an eClinRO provider.

  8. Comprehensive Services For Ophthalmic Drug Development 2/20/2025

    To maximize bioavailability while preserving vision and maintaining the structural integrity of the eye, formulation and delivery strategies must be meticulously designed.

  9. The Complexities Of Early Phase Ophthalmic Drug Development 2/20/2025

    Navigating the landscape of ophthalmic drug development can be challenging. Check out this scientific journal that outlines potential challenges, and how to overcome them.

  10. Alzheimer's Trials: Replacing Reams Of Paper For LAR Consent 2/18/2025

    Explore a structured solution to automate the Legally Authorized Representative (LAR) workflow, ensuring consent, reconsent, and assessments are accurately documented and compliant.