"We know you depend on Quality Data..& so do we"
As an investigative site, we are accountable not only to ourselves, but to our Sponsors as well as the laws & regulations that govern research itself and we take that responsibility seriously. Led by former FDA inspector of 13 years, Joe Kaufman, our Quality Assurance Department is dedicated to the essential need of making sure our science is professional…and your data is as accurate, compliant, and trustworthy as it can be.
Since the conception of Community Research in 1995, our attention to detail, adherence to FDA Regulations and the ICH GCP Guidelines, and continuing staff education have enabled us to achieve outstanding FDA Inspection and Sponsor Audits.
- FDA Inspections conducted in April 1997 - No form 483 was issued: No objectionable conditions or practices were found.
- Since 1995 we have also had over 30 Sponsor/CRO Audits all with similar positive findings.
- Established Independent Quality Assurance Program composed of internal audits, SOP development and maintenance, and ongoing staff training.
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