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Auditing
1. Auditing of clinical research organizations such as Sponsors, Contract Research Organizations (CROs), Institutional Review Boards
(IRBs), and Clinical Investigators, where we apply a Systems-Based review of procedures, policies, study data, training, and the
various processes involved.
- We are not simply a check-list type auditing company just observing if you have certain systems, but do you have the proper
systems and are they functioning properly independently and along with the other systems for research.
- Our audits can be systems audits, Mock FDA Audits, or protocol-specific audits.
- We can audit to the US FDA 21 Code of Federal Regulations (21 CFR), International Conference on Harmonisation (ICH) E6, your
Protocols, your SOPs, and perhaps other standards you might apply.
- Our audit reports include graded observations/findings, an overall audit grading, as well as recommendations for improvement
and corrective actions.
- Our auditing rates range from $150 – 225 per hour USD, plus travel expenses
- We employ former US Food and Drug Administration Investigators and well-experienced Clinical Research Professionals to conduct our audits.
2. We also conduct Good Manufacturing and Good Laboratory Practice Audits.
Following is the short list of the services we offer. If you wish to know more about our Clinical Research capabilities, send an email to: support@helixresearchcenterworld.com.
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