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At Clinilabs, we understand that a CRO’s job is not simply to deliver data, it’s job is to deliver data that can withstand audit by regulatory authorities. Perhaps that is why we’ve successfully passed dozens audits by large pharma companies, and recently completed a routine inspection by the FDA 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, ensuring the integrity of source and CRF documents at every step. Quality control processes are followed by routine and periodic internal audits. Observations are noted, and corrective actions are initiated, before database lock.
Our Quality Assurance and Compliance department oversees a vendor management office. This office establishes criteria for all of the sub-vendors we use, and conducts vendor audits to assure criteria are met.
- Internal audits
- External audits
- Quality control
- Vendor management
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