Clinical Operations

PRA's Clinical Operations Group provides clients with highly-trained, locally-based, study teams globally. Our local project teams develop rapport with study sites, ensuring quality and on-time receipt of all clinical deliverables. PRA's Lead Clinical Research Associates (LCRAs), Clinical Research Associates (CRAs) and In-House Clinical Research Associates ensure a successful site startup, maintenance and close-out for each trial. Key competencies of PRA's Clinical team are:

• Knowledge of local regulations
• Medical practices
• Safety
• Therapeutic-specific knowledge

Project Start-up Services

PRA's Project Startup Services team is dedicated to rapid site activation for clinical trials. Our specialists combine global and country-specific expertise to deliver economy and efficiency in study site recruitment and retention.

PRA's startup 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)

Clinical Site Monitoring Services

PRA monitors investigator sites in over 60 countries. PRA's CRAs:

• Assess sites for ability to conduct study
• Activate sites on completion of start up activities
• Monitor recruitment, eligibility, and informed consent procedures
• Validate and verify data collected at site
• Review IP and accountability records
• Review adverse events and Serious Adverse Event reporting procedures
• Monitor Investigator Site Files

In-House Site Management

PRA clients benefit from our strong support structure for clinical teams. In-House CRAs 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 activities include:

• Reviewing and processing site documents in eTMF (electronic Trial Master File)
• Assisting with resolution of site queries
• Tracking clinical activity status in the PRA Clinical Trial Management System
• Tracking and assisting with resolution of data queries
• Providing support to CRAs and LCRAs