Medical Affairs
Medical Affairs supports the planning, conduct and evaluation of clinical studies worldwide with a primary focus on patient safety.
The Medical Affairs team consists of experienced physicians that have expertise in nearly all areas of medicine. They provide contracted medical services and liaison services relative to:
- Implementation and conduct of clinical trials, including inclusion/exclusion criteria
- Primary medical contact to the sponsor, investigative sites, and project team
- Connections to clinical specialists and thought leaders
The Medical Affairs Support Center is the main point of contact for questions and issues involving medical monitoring. It is staffed with Medical Monitoring Associates who serve as high-level interface between PRA's Medical Directors and Clinical Monitors. They address questions from investigative site personnel, ensuring that all issues and requests are handled in an expedited fashion.
PRA's Medical Affairs team protects each patient's safety on an ongoing basis through:
- Ongoing laboratory review
- SAE/AE review
- SAE/AE Coding review
- CRF review
These reviews are an important component for detecting safety issues from the outset in a clinical trial. Combining the ongoing Medical Monitoring with PRA's Safety Profiling/Benefit-Risk Assessment review is an effective method of monitoring a drug's safety profile.
Phase I-IIa
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Therapeutic Expertise
