Clinical Trial and Disclosure Transformation

Challenge

A multinational Fortune 500 pharmaceutical, medical devices, and consumer packaged goods company had grown through acquisitions and was challenged by different organizational structures, processes, IT systems, and cultures across business segments. Of particular importance, the company needed to harmonize decentralized clinical trial disclosure (CTD) operations and establish centralized, optimal solutions to meet the needs of each business segment and align with the overall company strategy.

Approach: Think + Do

Acquis partnered with the client to define and operationalize an enterprise-wide virtual center of excellence to reinforce the organization’s commitment to compliance. Acquis executed numerous key activities, including:

• Creating the business unit strategy and designing the target operating model
• Defining and establishing enterprise data disclosure processes flexible enough to support differing business models but with sufficient harmonization to allow for centralized control and reporting
• Identifying and implementing IT systems and tools to facilitate real-time decision making and track compliance across the global enterprise
• Clearly communicating throughout the organization the need, impacts, and benefits of change
• Managing internal cross-functional teams and leading project management initiatives to

Results

The new operating model has allowed the client to harmonize and increase the efficiency of CTD processes effectively, as well as foster ongoing collaboration across its three business segments.