Application Notes & Case Studies

  1. Expand Bandwidth With A Trusted Regulatory Writing Partner 9/18/2025

    Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

  2. Duchenne Muscular Dystrophy Trial In China 9/17/2025

    A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.

  3. Revitalizing Recruitment In A Lupus Rescue Study 9/11/2025
  4. 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.

  5. 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.

  6. 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.

  7. 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?

  8. 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.

  9. 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).

  10. 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).