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Transparency and Reliability
Adjudication can be a tool to improve the confidence of trial data, although it is essential to have a clear and defined process. Historically,…
Featured Insights
Ask the Experts: Understanding Juvenile Idiopathic Arthritis
In light of JIA Awareness Month, its treatments, its stigma, and more, we spoke with Dr. Johnny Peppers, Executive Director of Drug Development for…
PRA Teams with Microsoft to Enhance COVID-19 Monitoring
Over the past several months, participants in PRA Health Sciences’ Health Harmony COVID-19 Monitoring Program have had vital information about…
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White Paper
Starting with Status
Small and medium-sized enterprises (SMEs) are the backbone of Europe’s economy, representing 99% of all EU businesses. SMEs are often innovative…
White Paper
New Agency Liaison Opportunity in the EU
Scientific advice is a regulatory process expected to, “facilitate timely access to safe and efficacious medicinal products to patients and users of…
White Paper
The Evolution of FSP: Not Just for Large Pharma
The ebb and flow of a pharmaceutical or biotechnology company’s clinical development portfolio places an emphasis on ensuring that the resources…
White Paper
A Shift in Thinking: How Investments in Supply of CRAs is Better than Competing with Demand for CRAs
In this white paper, you’ll learn more about how PRA is meeting the demands of the dynamic clinical research industry by supplying the next…
White Paper
Regulatory Considerations for Biotech
Innovative biotech products present a complex regulatory environment. For this reason, a formidable regulatory strategist is a critical member of the…
White Paper
Glaucoma: Under Pressure to Treat
Glaucoma remains a chronic and visually debilitating disease that has vast public health implications, as well as pronounced effects on individual…
White Paper
Partnering with Patients to Develop Meaningful Endpoints – Practical Considerations
Selection of appropriate endpoints for rare disease clinical studies can be challenging but is critical to assessing the efficacy of new medicines.…
White Paper
Chemistry, Manufacturing, and Controls (CMC) in Drug Development and Life Cycle Management
This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development.…
White Paper
Indication Expansion
A single product candidate that provides clinical benefit across multiple indications and patient populations allows more conditions to be treated…