Expanded Access Trials

PPD understands the unique challenges of expanded access trials, which give at-risk patients earlier access to experimental drugs. Our dedicated team, experienced in the special regulations and processes of expanded access trials, conducts these studies with the same rigorous scientific and regulatory standards that we apply to Phase II-IIIb trials.

Compassionate, Powerful Programs

Research in the critically ill arena can often help accelerate product approval and generate goodwill in the medical and patient communities. Expanded access trials provide future prescribers direct access to and valuable experience with a new drug, while providing potentially life-preserving therapies to critically-ill patients. Our goal is to make these trials user-friendly and create good will toward your product.

Comprehensive Services

Expanded access programs can be conducted in tandem with Phase III programs to generate real-world data early in the development process. Our full spectrum of services includes:

• Study design, protocol writing and case report form design
• Site training and ongoing support
• Communication, including interactive voice response systems, fax and e-mail
• Coordination of agreements and contracts
• Fulfillment of study materials
• Study progress tracking
• Collection and analysis of data
• Medical writing

Dedicated Resources

Our extensive infrastructure provides access to dedicated experts for these post-approval resources:

• Health outcomes
• Late stage trials
• Medical communications
• Consumer health