Insights on Clinical Trials

  1. 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.

  2. 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.

  3. 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.

  4. 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?

  5. 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.

  6. 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).

  7. 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.

  8. Rescuing A Global Program For NDA Success 8/12/2025

    Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

  9. AI-Enhanced Clinical Project Management For Cell And Gene Therapy Clinical Trials 8/12/2025

    Consultant Jessica Cordes explores two of the most critical uses of AI for cell and gene therapy clinical trials: real-time patient journey coordination and predictive enrollment. 

  10. Best Practices For Regulatory Excellence In Clinical Research 8/7/2025

    Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.