Develop and implement strategies for clinical research compliance
At PMI, we think that research compliance is the result of a combination of factors: well-designed protocols and data capture forms; appropriate clinical standard operating procedures; effective site training and monitoring; and periodic project audits. While we maintain our own ISO certified Quality Management System, we work with you to develop and implement compliance strategies specific to your study and oriented toward the successful clearance of clinical study inspections by regulatory authorities.
Our commitment to compliance begins with project teams comprised of individuals who are experienced with the application of Good Clinical Practices (GCP). We support our teams with relevant clinical study procedures, guidance with respect to GCP expectations, and detailed checklists and logs to facilitate appropriate performance of study–related activities. Early in each project, we begin training, and we monitor and continue to train throughout your study.
Our Research Compliance services include:
- Audits/FDA Inspection Support
- GCP Seminars
- Clinical SOP Development