Clinical White Papers and Case Studies

  1. Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research 10/6/2025

    By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.

  2. Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems 10/6/2025

    Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.

  3. Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech 10/2/2025

    This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.

  4. Increasing Efficiency And Reducing Drug Waste 10/2/2025

    Discover how streamlined clinical supply chain management helped accelerate study timelines, reduce costs, and support global treatment delivery through a strategic technology partnership.

  5. Navigating Adverse Immunostimulation: A Practical Guide For Clinical Researchers 9/30/2025

    Explore a systematic approach to evaluate adverse immunostimulation (AIS) in drug development through standardized biomarker sampling and tailored management strategies.

  6. Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays 9/25/2025

    Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.

  7. Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy 9/25/2025

    Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

  8. Use Of Epiontis ID In A Phase 2 Psoriasis Trial 9/25/2025

    Mirikizumab’s Phase 2 trial explores IL-23 inhibition in psoriasis, measuring immune cell changes to assess its potential for long-term disease control and flare-up prevention.

  9. How AI Is Reshaping Trial Design, Execution, And Disclosure 9/25/2025

    AI has quietly embedded itself into the operational heart of clinical development, where it is accelerating decisions, reducing manual burden, and improving outcomes.

  10. Decentralized And Community-Based Solutions Driving Women's Healthcare 9/24/2025

    Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.