Proactive Auditing to Ensure CRO Corporate Compliance and Contract Adherence
Thursday, June 13 2013
2:00 pm – 3:15 pm
Location: Complimentary webinar
It is best practice for a manufacturer’s annual risk assessment and audit plan to include a focused evaluation of its CROs that not only considers the clinical processes and activities transferred and the regulatory consequences therein, but that also considers the CROs’ corporate compliance program and associated controls.
CIS has worked with manufacturers to build audit programs targeting compliance and contracting vulnerabilities and performed the transactional testing required to expose areas of concern, potential compliance threats, and/or business risks at the program level as well as at the individual investigator level. As a result of our audits, CIS has identified areas where policies and procedures must be improved and the internal control environment made more stringent; resolved issues of noncompliance with vendor contract terms; and uncovered substantial overpayments to investigators and third-party vendors used by CROs. Join CIS for a case study presentation that provides an overview of our first-hand experience and unique insight into working with and auditing CROs.