PRA’s Center for Global Drug Development (CGDD) knows what it takes to deliver new drugs to market. Through extensive sponsor-side experience, business acumen, and critical understanding of drug development, we assist clients ranging from emerging biotech to large pharmaceutical companies in the design and execution of global drug development and asset management strategies.
PRA’s Center for Global Drug Development assists clients in the design and execution of global drug development and asset management strategies. Our team works closely with subject matter experts across PRA and client organizations to ensure that clients’ scientific strategy and business objectives are translated effectively. We help clients meet their goals through planning, support, and oversight throughout the product lifecycle.
Strategic Drug Development Services
Our team of former industry drug development leaders know what it takes and understand the challenges of delivering new assets to the market and the patients that need them.
In collaboration with senior subject matter experts across PRA functions we help clients meet their goals through planning, support, and oversight throughout the product lifecycle. We offer a wide range of drug development services focusing on an end-to-end view of drug development including:
- Development Program Gap Analyses including Nonclinical, Toxicology, Clinical and Regulatory
- Global Drug Development Strategy Development including Nonclinical, Toxicology, Clinical and Regulatory
- Full scope Biosimilar Program Development and execution
- Global Clinical Program and Regulatory Strategy design and execution
- Regulatory Strategy, Agency Meetings (including Briefing Packages) and Submissions (IND, NDA, BLA, study specific)
- Due Diligence Activities – not limited to in license only
- Product lifecycle management; new indications, new uses and populations
Committed to patients.
PRA focuses on the patient throughout the drug development process. Our development experts apply their expertise to make products and treatments accessible to patients—whether it’s a consultation in specific medical industry areas, early and frequent communication with patient advocacy groups, or an entirely new solution.
Global drug development guidance in all major market regions and countries
We’re staffed by former pharmaceutical development leaders, each with over 25 years in the pharmaceutical and biotechnology industries. We possess experience across the development lifecycle, including leadership of global cross-functional development teams.
We maintain strong working knowledge of key functions, such as:
- CMC, formulation and drug supply
- Clinical pharmacology
- Clinical operations
- Safety and Toxicology
- Non-clinical pharmacology
We understand that drug development is a complex interplay of many different activities and know how and when these need to come together to deliver drugs to the market. We work with our PRA colleagues in various functions and business units across the company to help ensure the various activities come together seamlessly and to ensure efficient and timely product development
Focused on the big picture.
We always ask, “What’s next?” to understand how the current program or study design impacts future studies and the probability of success.
What are the key risks in the development program, which need to be mitigated against and which risks may be worth taking?
Our integrated approach combines data, technology, patient focus, and flexible delivery models to drive drug development. With this approach, solutions and services come together and deliver new products to patients.
Master Protocols in Clinical Trials
Master protocols are a powerful but under-utilized option for complex clinical development programs. Our Greg Licholai, MD, explores:
Collaboration in Neonatal Study Addresses and Resolves Multi-Stage Difficulties
PRA’s project team turned around a challenging neonatal seizure study to enable successful recruitment. The relationships between the sponsor and the…
Ask the Experts: What Improvements are Being Made for Psoriasis Treatments?
October 29 is World Psoriasis Day, an annual day devoted to people with psoriasis/psoriatic arthritis. It is a day that was started by psoriasis…