An audit is a systematic & independent examination of any activity.

As Clinical Research systems are becoming robust and multiple players (multiple sites, changes in the site personnel within a clinical trial, multiple roles played by the same individuals, usage of vendors, etc.) are being involved, the business risks are also rapidly multiplying. Hence, the managements of clinical trial processes are in need of assurance by cross-verifications by autonomous bodies to certify that the organizations & / or the clinical studies under consideration are in the right path and are not erring on the legal parameters too.

With this background, the views and judgment of an external auditor(s) (consultant(s)) adds value to those who have been regularly involved with the process. It is to be understood that a series of “Complex combination of factors lead to making a decision” and the experience and competence of individuals who are assigned to conduct the audits do not stop at identifying the issues but also should extend to suggest the way-outs for the complex situations in order to save the integrity of the data collected thus far.

To ensure this process, we at Consortium Clinical Research, provide experienced and skilled auditors to not only look beyond the obvious but in addition, propose alternative corrective measures where required.

The different types of audits that may be conducted by us include (but are not restricted to) -

  • Clinical Study Report Audits
  • CRO / Vendor Audits
  • Database Audits
  • GCP Audits
  • In-house Files Audits
  • Investigator Site Audits
  • Laboratory Audits
  • SOP Audits
  • Systems Audits


Do you know the difference between Adequacy Audits and Compliance Audits?

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