Product Registration Services
PRA is transforming clinical trials through our people, innovation and transparency. We have achieved a level of expertise that enables us to work across a range of compounds, from niche treatments to blockbuster drugs and biosimilars. Our Product Registration group executes complex, global Phase II-III studies for a variety of indications.
PRA provides personalized service customized to the unique requirements of each study. We serve our clients in 80+ countries by combining therapeutic and operational expertise with in-depth local knowledge. PRA supports our global reach through flexible and reliable service delivery. With eClinical solutions, advanced technological tools and finely tuned systems we achieve seamless delivery and operational transparency throughout our organization. Our 40 drug approvals demonstrate our successful approach to clinical research.
PRA’s success in helping clients achieve their goals must be ascribed to our therapeutic expertise, commitment to quality and a close involvement of the entire project team throughout the study.
Dedication to quality service is part of who we are and is highlighted in the following areas:
- Proven therapeutic expertise that includes our own drug development experts, regional key opinion leaders and a global network of proven investigators
- Strong project leadership with an ability to interact seamlessly across borders—sharing and benefiting from a collective experience
- People on the ground throughout the world who are intimately familiar with local regulatory requirements for study start-up, execution and subsequent submission. Local contacts enable us to recruit and sustain program-driven patient populations
- A unified, state-of-the-art global Information Technology (IT) infrastructure for ease of communication, data transparency and interim reporting
- The PRA Service Delivery Model provides the support of experienced senior staff for the duration of the study along with superbly trained internal staff and unique performance management feedback to you, the client