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External Auditors
WHY EXTERNAL AUDITORS?
WHY SELECTING EXTERNAL AUDITORS IS A BETTER CHOICE?
Below are some of the important reasons why external auditors should be chosen for conducting audits
  • They are not associated with either the sponsor or the CRO or any other interested party, Independent Audit agencies can offer unmatched insight in the auditing process.
  • A skilled and experienced auditor is able to pick up a minor inconsistency, deduce possible reasons, and then investigates, uncovering significant underlying issues.
  • An external Auditor has handled various projects so has a wide exposure and in depth understanding of how and when things can go wrong.
  • He/she could be an out of box thinker as he is not physically present, related to any one in the CRO/ Sponsor’s group.
  • These insights and findings can then be used to fix the gaps but also those to create a robust system to avoid the costly mistakes in the future.
NEED OF AUDITING SERVICES
The need for auditing services in clinical research has been much emphasised. All regulated markets lay importance to quality of clinical trial be it before the clinical trial, during the clinical trial or after the clinical trial. For most Auditees, the audit process is one of uncertainty, unpredictability, and uneasiness. The process preparation is tiring, frantic and sometimes grueling. For many companies, the failure of any audit may be not only become very costly, but also very concerning, because in an industry that is one of the largest in the world, the word of mouth is more worrisome. As large as the industry is, it is also very influential. Also, since many sites are now participating in Clinical trials, many external players like SMOs, Central labs, translation agencies) have come in to being , electronic data capture has taken over paper CRF filling so there is a far more possibility of high error rate, so robust quality systems needs to be in place proactively to check compliance at all these levels.
What's New
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
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