Regulatory Affairs White Papers & Case Studies

  1. Vaccine Trial Sees >90% eCOA Adherence 5/1/2024

    Discover how we addressed vaccine trial challenges and drove remarkable success, achieving over 90% adherence to eCOA, ensuring active engagement from the trial participants, and yielding consistent, reliable trial data.

  2. CRO Takes Trial Build Times From Weeks To Days 5/27/2025

    Recognizing the inefficiencies in traditional build processes, a top global CRO partnered with Medable to transform its approach to clinical trial launch.

  3. Driving A High-Adherence LTFU Trial Without An EDC 10/29/2025

    Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.

  4. Using eConsent Data To Populate Site And Sponsor Data Systems 10/7/2024

    A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.

  5. Rapid Assessment Of Fab-VHH Expression 3/25/2026

    Find out how a 10-day expression screening program rapidly identified optimal gene orientation for a bi-specific antibody fragment fusion, achieving up to 570 µg/mL soluble, active product.

  6. 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.

  7. The Role Of Peptones In Boosting Monoclonal Antibody Production 5/9/2025

    Peptones have become a key tool in CHO cell bioprocessing, enhancing monoclonal antibody yield and quality.

  8. 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.

  9. Overcoming Analytical Bottlenecks In Oligonucleotide Drug Development With Automation 1/29/2026

    Growing oligonucleotide complexity is straining traditional analytical workflows. See how automated LC‑UV‑MS processing offers a scalable way to boost throughput and reduce manual effort.

  10. Innovating The mAb Characterization Process 11/14/2024

    Understanding the characteristics of a molecule's "personality" is crucial for optimizing development and manufacturing. Learn how to overcome the challenges in the characterization process.