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