Clinical White Papers and Case Studies

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

    Recruitment hurdles are overcome by leveraging engaged, data-sharing patient communities. See how a strategic, patient-centric approach delivered a pre-qualified clinical trial cohort quickly and efficiently.

  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. Advancing Alzheimer's Disease Therapies 9/3/2025

    By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.

  4. De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital 9/3/2025

    For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.

  5. Writing An IND Module 3 For Cell And Gene Therapy Products 9/1/2025

    This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

  6. Enhancing Clinical Trial Flexibility 9/1/2025

    Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.

  7. Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape 9/1/2025

    Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.

  8. 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.

  9. The Untapped Power Of Real-World Data And AI In Pharma Commercialization 8/27/2025

    Harnessing RWD in commercialization bridges the gap between approval and patient access, equipping companies with actionable intelligence to deliver life-changing therapies to more patients.

  10. Master Protocols: Implementing Effective Treatment Adaptations 8/25/2025

    From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.