CMK Helps Pharmaceutical Leader Streamline and Integrate Processes and Procedures for Study Teams Following Merger by CMK SELECT CMK SELECT CMK SELECT
CMK SELECT CMK SELECT CMK SELECT
The Challenge When two large pharmaceutical companies merged, the study teams struggled with a lack of clarity over which operating models to follow for their respective studies. With heritage procedures and IT systems in place across both entities, and pros and cons to each depending on the lifecycle management processes at play, the client needed
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CMK Helps Pharmaceutical Leader Streamline and Integrate Processes and Procedures for Study Teams Following Merger

by CMK SELECT / /
people gathered around a conference table looking at documents

The Challenge

When two large pharmaceutical companies merged, the study teams struggled with a lack of clarity over which operating models to follow for their respective studies. With heritage procedures and IT systems in place across both entities, and pros and cons to each depending on the lifecycle management processes at play, the client needed a way to define, streamline and integrate each disparate component for more efficient, audit-ready processes and protocols.

The Solution

CMK worked with the client to coordinate, compile and evaluate every operating model currently in use. They identified best practices and devised a mixed-models approach that assigned a specific operating model to each of the multiple processes. Recognizing the need for a central repository to house all pertinent information, CMK also partnered with key stakeholders to collect procedural documents and resources for every process, with source links to each respective system.

The Results

With the operating models and related IT systems defined and a single policy portal system that offers one version of the truth, the study team is well equipped to execute trials efficiently and without confusion. And with inspection-ready standard operating procedures in place, the team can quickly and easily respond to compliance inquiries.

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