Aml Research

Clinical Quality & Compliance

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