Blog
Decoding FDA Gene Therapy Guidances Part Three: Long-term Follow-ups
In Part Three of our Decoding FDA Gene Therapy Guidances series, we discuss the need for thorough long-term follow-up studies for these products, as…
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Blog
Blog
Decoding FDA Gene Therapy Guidances Part Two: Rare Disease
In Part Two of Decoding FDA Gene Therapy Guidances, we discuss three separate guidances that provide further insight into how sponsors can safely and…
Blog
Decoding FDA Gene Therapy Guidances Part One: Chemistry, Manufacturing, and Control
In Part One of our Decoding FDA Gene Therapy Guidances series, we discuss the significance of several new FDA guidances regarding human gene therapy…
Case Study
Multi-stakeholder Collaboration Achieves Rapid Study Start-up for an Advanced Therapeutic
PRA worked with an emerging biotech firm to implement a first-in-human clinical trial using a live biotherapeutic product for a rare disease…
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Government Services
PRA Health Sciences offers our services as a contractor for US Government (USG) contract-funded projects and as a commercial procurement vendor for…