This webinar will bring together perspectives from a sponsor, CRO, clinical site, and institutional biosafety committee (IBC) expert to explore strategies for expanding and optimizing CGT trial sites.
In the rapidly evolving field of adeno-associated virus (AAV) gene therapy, patient advocacy groups (PAGs) have emerged as critical partners driving scientific, operational, and regulatory progress. Their influence extends far beyond awareness and fundraising—they help shape trial design, regulatory engagement,...
Cell and gene therapies require 6–15 years of follow-up to monitor long-term safety and efficacy. Traditional sites can struggle to sustain contact and compliance over such extended timelines. This guide shows how decentralized solutions make long-term follow-up (LTFU) more sustainable,...
Long-term follow-up (LTFU) is a defining feature of oncology and cell and gene therapy (CGT) trials, where post-treatment monitoring often spans 2 to 15 years. These extended timelines allow regulators to assess long-term safety and efficacy from detecting delayed adverse...
The rapid advancement of cell and gene therapies (CGT) continues to reshape the clinical development landscape. As these innovative modalities move beyond ultra-rare diseases and academic institutions, clinical trial stakeholders must contend with a new set of operational realities—chief among...
Adeno-Associated Virus (AAV) gene therapy represents a breakthrough in the treatment of genetic diseases. Yet, recent clinical trials have highlighted safety concerns, including severe adverse events. These incidents underscore the critical importance of embedding safety-focused practices into every stage of...
Selecting the right CRO partner is a critical factor in the success of any cell and gene therapy (CGT) program. With global reach and deep therapeutic expertise, Premier helps navigate complex regulatory and development landscapes—reducing risk and accelerating timelines in CGT...