Regulatory Compliance & Quality Assurance
Sinclair is fully GLP-compliant and our personnel have many years of GLP experience. Sinclair has an independent Quality Assurance Unit that audits the facility, protocols, in-life critical phases, raw data, and reports for GLP studies. Sinclair is inspected by the FDA on a regular basis.
Sinclair utilizes the following data capture and SEND dataset creation systems:
- Pristima® Version 7.1 or newer
- SEND Savante ™ 7.4.0 BUILD 16
Sinclair Research Center is proud to offer GLP data sets in SEND (Standard for Exchange of Nonclinical Data) format for submission to the FDA, which supports faster and better quality regulatory review. We use Xybion’s suite of programs, notably Pristima® and SEND Savante™ for quality data acquisition, reporting and dataset creation. Our dedicated study data team works in-house to ensure your data, from collection to submission, is accurately converted to SEND format. Systems are validated and have been assessed for 21 CFR Part 11 compliance. Data capture using the Xybion suite of programs allows Sinclair to provide cost effective and compliant management and oversight of studies.
Sinclair Research maintains certifications, licensure and successful audits and inspections from many agencies. These include:
- AAALAC- accredited
- State of Missouri agencies