Insights on Clinical Trials

  1. Audit Trails And Transparency: Changes In Clinical Data 8/18/2025

    Audit trails are not only a regulatory necessity but a strategic tool to ensure data reliability and accelerate high-quality clinical research outcomes.

  2. Faster, Smarter Start-Up: Launch Trials Without Bottlenecks 8/18/2025

    By pairing proven practices with modern technology, trials reduce start-up delays, cut costs, and ensure treatments reach patients faster.

  3. CDMS Software: What To Know For Your Clinical Trials 8/18/2025

    A clinical data management system (CDMS) is essential for ensuring efficiency, accuracy, and compliance in clinical trials by streamlining how data is collected, validated, stored, and reported.

  4. 2025 Global Report For In-Vivo CAR Cell Therapy 8/14/2025

    Explore global trends shaping in-vivo CAR therapies—delivery innovations, clinical trial momentum, and regulatory strategies across oncology and autoimmune diseases.

  5. LBPs: Unique Quality, Manufacturing, And Nonclinical Considerations 8/14/2025

    Live biotherapeutic products (LBPs) are emerging as a dynamic area of drug development, and their development demands tailored strategies that address both manufacturing and nonclinical complexities.

  6. Understanding Immunogenicity In AAV Gene Therapy 8/14/2025

    As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

  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. 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).

  10. 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.