Obesity White Papers & Case Studies

  1. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

    A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

  2. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

    A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

  3. Advancing Oncology Innovation With Adaptive Trial Designs 8/12/2025

    When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

  4. Rescuing A Global Program For NDA Success 8/12/2025

    Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

  5. Solutions From Research To Phase IV Studies/Surveillance 8/12/2025

    These integrated data-driven solutions combine secure, advanced AI, deep clinical expertise, and exclusive real-world data from leading medical societies.

  6. The Next Generation Of Oral Targeted Therapies 8/11/2025

    Solve the unique challenges of poorly soluble molecules like targeted protein degraders (TPDs), such as PROTACs and molecular glues, seamlessly accelerating your molecule from development to commercialization.

  7. eCOA: Participant-Focused Electronic Assessment Capture Built For Global Trials 8/11/2025

    High-quality outcome data is essential to clinical trial success, and this eCOA solution provides participant-first design features while supporting multiple modalities.

  8. The Strategic Advantage Of eCOA And IRT 8/11/2025

    The future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.

  9. The Big Impact Of Medable AI 8/8/2025

    Streamline your clinical trial study creation by automating and accelerating the eCOA build process. Generative AI models perform your repetitive configurations and significantly shorten build times.

  10. Removing Translation Bottlenecks With AI 8/8/2025

    See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.