Application Notes & Case Studies

  1. Maintain Compliance Through Divestiture Without Disrupting Operations 6/25/2026

    Facing a divestiture? Learn how to protect historical quality records and stay audit-ready throughout the transition. 

  2. DECODE CRS: Accelerating Immunotherapy Access And De-risking CRS 6/18/2026

    How does the DECODE CRS Coalition help trial sponsors standardize protocols and build a first-of-its-kind wearable dataset to lower development costs and safely de-risk outpatient care?

  3. Study Experience: Pancreatic Cancer 6/17/2026

    Discover how access to robust historical datasets is helping sponsors make smarter decisions earlier and increase the likelihood of clinical and regulatory success

  4. A Mission To Expand Recruitment Territory 6/11/2026

    Learn how a proactive feasibility approach helps sponsors strengthen enrollment forecasting, mitigate risk, and implement timely interventions that improve study execution and clinical development.

  5. Incorrect Clinical Trial Enrollment Is Preventable. A Tale Of Three Case Studies 6/5/2026

    See how three clinical trials used centralized eligibility review to accelerate enrollment, eliminate enrollment-based protocol deviations, and keep studies on track, even at a global scale.

  6. Successful SwissMedic Marketing Authorization Application For An Oncology Therapy 6/4/2026

    See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.

  7. End-To-End Clinical, Biometrics, And Regulatory Support In Neurology 6/4/2026

    Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.

  8. Building A Scalable Oncology Engine In A Dynamic Market 6/3/2026

    Learn how a top-10 global pharmaceutical company partnered with Medable to rapidly scale the number of oncology trials it could concurrently conduct.

  9. Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration 5/27/2026

    Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.

  10. Relieving Pressure During Preparation Of A High-Volume sNDA 5/27/2026

    Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.