Protocol Design White Papers & Case Studies

  1. 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.

  2. 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.

  3. 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.

  4. Generate High- Quality Evidence For Pediatric Trials 9/1/2025

    Generate the high-quality data required to advance safe and effective therapies for children with solutions that address the unique challenges of pediatric trials.

  5. 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.

  6. 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.

  7. Decentralized Trials Support: Direct-To-Patient Supply Management 8/25/2025

    Direct-to-patient shipments are reshaping decentralized trials by placing patient convenience at the center of study design.

  8. 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 with minimal disruption.

  9. Unique IRT Implementation Considerations For Personalized Medicine Trials 8/22/2025

    The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.

  10. 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.