Insights on Clinical Trials

  1. 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.

  2. 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. 

  3. 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.

  4. ASCO 2025: Key Takeaways From The American Society Of Clinical Oncology Annual Meeting 7/31/2025

    Cell and gene therapy for cancer continues to advance. New data show promise, alongside discussions on safety and scalability.

  5. Comply With The New NIH Transparency Rules For r/sNA Molecule Research 7/30/2025

    Review new transparency requirements for NIH-funded institutions engaged in research involving r/sNA molecules and regulations for Institutional Biosafety Committees (IBCs).

  6. Optimizing Commercial Distribution As You Prepare To Launch Your CGT 7/29/2025

    An effective commercial distribution strategy is crucial for new cell and gene therapies, helping manufacturers navigate challenges and ensure patient access.

  7. Strategies For Optimizing iPSC Cryopreservation, Storage, And Post-Thaw Quality 7/29/2025

    Developing iPSC therapies demands meticulous cryopreservation, smart automation, and risk-based post-thaw quality control to bridge lab development with cGMP manufacturing. The sensitivity of iPSCs requires tailored protocols and a deep understanding of cell behavior under scaled conditions, ensuring consistent, viable products.

  8. Guiding Principles For Process Development And IND Readiness 7/25/2025

    Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.

  9. GLP‑1 Clinical Trial Eye Safety: Semaglutide Eye Risks 7/24/2025

    While GLP-1 receptor agonists offer significant health benefits, proactive eye care and vigilance are essential to mitigate the risk of irreversible ocular conditions.

  10. Clinical Trial Support: Point Of Need vs. Traditional Solutions 7/24/2025

    Examine the limitations of traditional, fixed-location ophthalmic trial sites and how a mobile assessment model can significantly improve patient retention while ensuring high-quality data collection.