Insights on Clinical Trials

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. Site Networks And Hybrid Solutions 7/22/2025

    Learn how community- and patient-centric site networks that have DCT capabilities are able to work with a broad-range of site types.

37. In-Vivo CAR Therapies — Global Research And Development Landscape 7/15/2025

    Delve into the evolving in-vivo CAR therapy landscape, examining key technological innovations, major industry players, recent clinical progress, and regulatory developments.

38. 4 Centralized Comparator Sourcing Models To Fortify Supply Chains 7/15/2025

    A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

39. How To Build Effective Clinical Trial Oversight And Leadership 7/14/2025

    In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

40. Writing Effective Clinical Regulatory Documents For Therapy Trials 7/11/2025

    Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.