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
CMK SELECT
43 Route 46 East, Suite 705 Pine Brook, NJ 07058 USA
Rachel Phone: (973) 244-6060

FORGOT YOUR DETAILS?

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.

Leave a Reply

Your email address will not be published. Required fields are marked *

Share on:

... KNOWLEDGE & INSIGHTS

CMK SELECT

CMK Brings Order to Pharma Company’s Struggling Multi-Product, Multi-Release Launch

AUTHOR: CMK SELECT

A privately owned, rapidly growing pharmaceutical company was charged with rolling out 22 releases for a multi-product launch in one year’s time. In the early stages of the program, the client struggled with a series of issues that,…
CONTINUE READING
CMK SELECT

CMK Helps Global Pharmaceutical Leader Streamline Processes and Protocols to Meet Government Requirements and Deliver Ongoing Operational Efficiencies

AUTHOR: CMK SELECT

The U.S. cardiovascular team of a global pharmaceutical company needed help responding to a new Corporate Integrity Agreement for two launch products. Resource-constrained at the time, they were looking for a streamlined and efficient way to satisfy the…
CONTINUE READING

LIKE OUR PAGE

FOLLOW US

GET LINKED IN

TOP