Auditing

ClinSearch performs internal and external audits of vendors and partners for your clinical evaluations and post-marketing studies under the responsibility of our Regulatory Affairs/Quality Systems Manager.

Our services include:

  • Study documents audits (study protocol, CRF…),
  • Trial Master File (TMF) Audits,
  • Investigator Site File audits,
  • Database Audits,
  • Clinical Study Report Audits,
  • System Audits (Quality Management Systems, Data management, SOP compliance).

Our standards are based on:

  • ICH — Good Clinical Practice,
  • GHTF and AHWP guidance,
  • Good epidemiological practice,
  • Application of regulatory requirements,
  • ISO 900,
  • ISO 19011,
  • ISO 14155,
  • ISO 13485,
  • ISO 14971.

All audits are performed to assess the quality of study data and conduct and ensure compliance with the above-detailed standards. These standards correspond to your study type (clinical trial or epidemiological study, evaluation of a drug or a medical device, etc), as well as appropriate Standard Operating Procedures (SOPs) and the study protocol. According to your company’s preference, either ClinSearch’s Standard Operating Procedures (SOPs) or yours can be used.

Please see also our Quality Policy.