Aml Research

Clinical Quality & Compliance

Our Clinical Quality & Compliance (CQC) group can advise your company on ensuring adherence to protocols and international regulatory guidelines, verification of integrity of trial data and protecting research subjects' rights and welfare.

The GCP audit and consulting service includes:

  • Clinical quality assurance audits
  • Clinical investigator site audits (routine, for cause, and pre-inspection audits)
  • Clinical database audits and study report reviews
  • Clinical study document 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

 

In addition to the auditing services, our QCQ group can also provides you with:

  • Support in set up and maintenance of quality systems and quality documents
  • Change control and change management
  • Training of quality assurance and clinical research personnel

 

The CQC group not only provides services to external clients but also provides a comprehensive internal clinical quality and compliance program within AML to ensure we work according to the highest quality level possible.