12.19.25 -- Viability On The Line: Defining Minimum Quality For CGT Raw Materials

Cold storage units like refrigerators, freezers, and ULT freezers are vital to scientific progress, which preserves sensitive materials and supports breakthroughs in medicine, especially amid the rise of cell and gene therapies.

Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

From patient identification to reimbursement, commercializing cell and gene therapies is uniquely challenging. Learn five best practices to ensure your innovative CGT reaches the patients who need it.

Accelerate the future of precision oncology by driving innovation, optimizing clinical development, and expanding access to targeted therapies that transform patient outcomes.

Uncover how sponsors, CROs, and study monitors can navigate FDA expectations and Institutional Review Board (IRB) requirements when integrating AI and Software-as-a-Medical-Device into clinical trials.

Assimilate how comprehensive immune profiling and translational models can illuminate these mechanisms, inform dose selection, and guide the next generation of immunotherapies toward safer, more targeted innovation.

CISCRP’s 2025 survey reveals key clinical trial insights: altruism drives participation, trust in pharma lags, and most are comfortable with AI analyzing medical data.

A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial data generated outside a U.S. IND, in a New Drug Application (NDA).

See how you can leverage a system that offers flexible data delivery formats and seamless integration into commercialization workflows while also ensuring HIPAA-compliant deidentified data for patient privacy.

By combining strategic foresight, operational efficiency, and financial incentives, Avance Clinical empowers biotech companies to navigate funding challenges and bring innovative therapies to market.