PRA’s Clinical Operations group provides clients with highly-trained, locally-based study teams. Our local project teams develop a strong relationship with each study site, ensuring consummate quality and on-time receipt of all clinical deliverables. PRA's experienced clinical research teams lead the study to ensure a successful site start-up, maintenance and close-out for each trial. Key competencies include:
- Knowledge of local regulations and country-specific expertise
- Knowledge of medical practices
- Safety
- Therapeutic-specific knowledge
PRA's project start-up services include:
- Recruiting investigational sites
- Supporting PRA Regulatory Affairs with regulatory authority submissions
- Coordinating ethics committee approvals
- Collecting and reviewing initial essential documents
- Closing investigator contracts (clinical trial agreements)
PRA clients benefit from a strong support structure for clinical teams. Our in-house clinical research associates (IHCRAs) take responsibility for site management activities and logistics, allowing field CRAs to focus on the most critical aspects of their monitoring visit.
In-house site management includes:
- Reviewing and processing site documents in eTMF (electronic Trial Master File)
- Assisting with site queries
- Tracking clinical activity status in the PRA Clinical Trial Management System
- Tracking and assisting with data queries
- Providing support to CRAs and lead CRAs
