White Paper
Bridging the Diversity Gap with Decentralized Trails
The current drug development research paradigm is flawed in that it fails to include a diverse and representative patient population. A new approach…
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
White Paper
The RACE for Children Act: How Industry Can Accelerate Readiness Through Collaboration With Patient Organizations
This whitepaper offers a high-level orientation around the key barriers to readiness and critical success factors for companies navigating the…
White Paper
Biotech and Early Engagement Considerations: What Companies Must Consider When Developing an Asset
Emerging biotech companies are a significant and burgeoning sector of the pharmaceutical development market. These companies often require unique and…
White Paper
Data Sharing & Anonymization - Current Overview of Data Sharing within Clinical Trial Transparency
Clinical trial transparency has emerged in recent years as a key function within pharmaceutical and academic organizations. Although trial…
White Paper
Plain Language Summaries - Keeping the End in Mind: Key Considerations for Creating Plain Language Summaries
Plain language summaries (PLS), also known as lay summaries and trial results summaries, educate participants and the public about clinical trial…
White Paper
Clinical Trial Disclosure - Requirements & Strategy Considerations within Clinical Trial Transparency
Clinical Trial Disclosure (CTD) is a compliance requirement mandated by various national laws and policies, and is at the heart of a paradigm shift…
White Paper
Global Pediatric Drug Development Collaboration Part Two
70% of medicines given to children have never been studied in pediatric populations. Children who need treatments represent a relatively small…
White Paper
Global Pediatric Drug Development Collaboration Part One
The pharmaceutical industry is unlike any other industry in that the products manufactured can dramatically improve, and even save, lives. This is…
White Paper
Pediatric Product Development Plan
Development of the Pediatric Study Plan (PSP) for the United States Food and Drug Administration and the Pediatric Investigation Plan (PIP) for the…
White Paper
Parents as Gatekeepers for Children with Cancer
The RACE for Children Act will require new drugs intended for adult cancer treatment to also be studied in pediatric cancers when the molecular…