I can help your company on adherence to protocols and international regulatory guidelines, verification of integrity of study data and protecting research subjects' rights and welfare.

The Clinical Quality & Compliance Services include:

Quality Management Systems:

• GAP analysis of existing QMS
• Support in set up and maintenance of quality systems and quality documents
• writing and review of Standard Operating procedures, policies and other QMS documents

Quality Control :

• Review of Clinical Study documents (Protocol, ICF, Clinical study Report, ...)
• Sponsor oversight activities like Co-monitoring visits with CRAs, review of monitoring reports, review of protocol deviations, set-up and follow-up of CAPAs

GCP audit and Consulting:

• Clinical quality assurance audits
• Clinical investigator site audits (routine, for cause, and pre-inspection audits)
• Clinical database audits and study report reviews
• System audits, to assess standard operating procedures (SOPs), processes and staff training programs and recommend improvements where needed
• Vendor audits, to evaluate vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations
• Inspection support, including mock visits.
• Risk assessment and trend analysis