Application Notes & Case Studies

  1. Revitalizing Recruitment In A Lupus Rescue Study 9/11/2025
  2. Preparing The Next Generation Of Clinical Research Professionals 9/4/2025

    Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.

  3. Accelerating Approval Pathway For Phase III Ovarian Cancer Trial 8/29/2025

    A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

  4. A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution 8/18/2025

    eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.

  5. Targeted Indication Selection Using Adaptive Design 8/12/2025

    What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?

  6. Advancing Dose Escalation Strategies With Bayesian Modeling 8/12/2025

    A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

  7. 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).

  8. 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).

  9. 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.

  10. 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.