ClinDatrix was founded on a strong quality system approach to all aspects of the business to deliver impeccable service to our clients. Our approach includes a full suite of SOPs, full validation of computer systems and quality assurance oversight of all internal processes and documents.
In addition, ClinDatrix provides quality assurance services to our clients that include:
- Gap Analysis and Process Mapping – Review existing guidance documents, department processes and work flow. We develop process maps and identify the SOPs, work instructions and QC checklists to be revised and/or implemented.
- SOP Services – Create de novo SOPs or review and optimize existing SOPs.
- Vendor Audits – Ensure that clients’ critical vendors’ compliance systems and processes are consistent with industry standards.
- Site Audits – Verify that all study documentation is in order in anticipation of a potential regulatory agency audit or as part of due diligence ahead of an acquisition or licensing agreement.
- Compliance and Quality Systems Evaluations – Pre-audit our clients’ facilities, processes and SOPs prior to visits from the FDA or other external auditors.