Product Acquisitions: Take a Closer Look at the Clinical Trial Data
Companies interested in quickly extending product pipelines through acquisitions should strongly focus on the clinical trial perspective in addition to the financial elements of the deal. Unidentified compliance gaps within a clinical program can lead to very expensive, time and resource-consuming FDA remediation activities for the acquirer. Clinical trial auditing could help mitigate risks and reduce liability by focusing on the clinical aspects including Good Clinical Practice (GCP) compliance, protocol accuracy and completeness, and data integrity. In addition, professional clinical auditors who are members of the due diligence team ensure any bias is removed or reduced as internal staff may not have extensive auditing experience and sometimes tend to see things from one perspective. Contact Anson to get the specifics about auditing capabilities.
