Immunotherapy studies are complex and development is fast-paced—we’re here to help you bring these exciting new investigative products to market.
Today’s immunotherapy landscape is rapidly advancing. PRA understands the unique challenges these studies present compared to other trials. Our cross-functional team of immuno-oncology, cellular, and gene therapy experts provide end-to-end support for these complex studies that test even the most seasoned project teams. No matter the size or indication of your program, we have the experience and expertise to help you every step of the way.
The Center for Immuno-oncology, Cellular, and Gene Therapy leverages our comprehensive experience and cross-functional experts to ensure best practices, training, and operational standards are applied to every immunotherapy or advanced therapeutic we work on. Our solution-oriented team partners with organizations of all sizes—from emerging biotechs to top 5 pharma companies—to build fit-for-purpose solutions that span from early- and late-phase development to bioanalytical lab capabilities.
Supporting the successful delivery of complex immuno-oncology, cellular, and gene therapy studies.
Enterprise experience is not valuable if project teams are unable to access and leverage it. Our Center pools knowledge and functional resources from across PRA to translate our extensive experience into individual project team delivery success.
Our cross-functional team has experience across all immunotherapeutic platform modalities, from checkpoint inhibitors, cellular therapy, and cancer vaccines to gene therapy, oncolytic viruses, microbiome, and intra-tumoral injections. Additionally, we centralize our training and resources to ensure our experts remain aware of the latest developments in this rapidly evolving field. All staff assigned to a study also receive modality-specific training to ensure they have the most up-to-date information available.
Optimizing operational strategy and accelerating timelines.
Timelines are more critical than ever in today’s competitive immuno-oncology space. Leveraging our medical informatics data, regulatory intelligence, therapeutic expertise, and operational experience, we develop a strategic approach for every operational plan to ensure the fastest start-up and overall clinical development timelines possible. We achieve this by optimizing protocol designs, leveraging data-driven site selection, maximizing enrollment potential, and driving efficient data analyses for faster and smarter drug development outcomes.
We also leverage our Early Phase Oncology Network which provides our sponsors with a credible network of high performing sites for first-in-human (FIH) and early phase oncology studies. Globally, our dedicated PRA start-up group has extensive institutional knowledge of immuno-oncology sites and robust regulatory expertise surrounding advanced therapeutic asset classes. This significantly decreases study start-up timelines and enables us to successfully take your trial wherever your patients are.
Efficiently fulfilling long-term follow-up requirements.
Gene therapy, including the administration of genetically modified cellular products, may result in sustained or permanent biological modifications with unique safety concerns. As a result, many of these products have unique regulatory requirements for long-term follow-up (LTFU) that vary by country and can last up to 15 years or beyond.
We work closely with PRA’s Real World Solutions group who specializes in rollover programs to efficiently fulfill these requirements. They plan and implement a customized LTFU strategy that consolidates data collection from one or more parent treatment studies into a single LTFU safety study. Our collaborative strategy to LTFU studies greatly reduces costs and operational burden while also ensuring data and regulatory compliance across your asset development platform.
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