Our expert Quality Assurance and Compliance Department has over 50 years of collective clinical research experience, ensuring the integrity of source documents, regulatory files and CRF data at every step. We fully understand that our job demands delivery of data that can withstand regulatory authority inspection. Our emphasis on quality is evidenced by successfully passing dozens of routine large pharmaceutical sponsor audits, as well as 3 recent successful routine FDA inspections with no observations.
How do we deliver audit-ready data? We are an SOP-driven organization that conducts quality control assessments of study data on a rolling basis. Quality control processes are followed by routine and periodic internal audits. Observations are noted and corrective actions are initiated, prior to database lock. Continuous training and education in Good Clinical Practice is essential. Both in-house training modules and formal, off-site research management seminars are provided to all coordinators and investigators. Our study staff members are all CITI-certified (Cooperative IRB Training Initiative). We’re very proud of our 40+ ACRP certified clinical research coordinators.
Our QA Team is responsible for:
- SOP Development, Revision & Implementation
- Sponsor and FDA Audit Preparation
- Staff Training
- “QA Tip of the Week” to Coordinators
- Standardization
- Upfront and Backend QA Procedures
- Investigator Lunch & Learn Series
