M&A DUE DILIGENCE READINESS AND INSPECTION READINESS

CRO and Vendor contracts done well is due to the negotiator's ability to link legal terms with operational study deliveries, understanding the dynamics and leverage possible risks and compromises within the written agreements made. To some Clients, this has not had the highest focus if time or skilled resources have been limited in the start-up phase, ending up with contracts either difficult to manage, of poor quality from a regulatory standpoint or simply not useful at all in case of disagreements with the CRO or Vendor.

Whether Client is preparing for a M&A due diligence process with a potential buyer or Client wish to ensure inspection readiness, the quality as well as the regulatory- and legislation compliance in CRO and Vendor contracs has to be in good order.

WIN Outsourcing Consult offers a full and detailed review of Client’s existing contracts/work orders to:

• Map all CROs/Vendors for each current running study
• Identify gaps and risks in the written commitments with the aim of potentially re-negotiate better terms or take other steps to risk-mitigate the study quality, costs, timelines or CRO collaboration and performance
• Review CRO/Vendor contracts for quality and consistency showing higher levels of transparency and oversight as preparations for a M&A due diligence processes or Inspections