
Clinical Trial and Disclosure Transformation
Acquis partnered with a Fortune 500 pharmaceutical company to design a new operating model and increase the efficiency of clinical trial disclosure operations.
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.
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