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  6. Biopharma Company Consolidates CRO Study Assets into One Archive/Repository Solution

Biopharma Company Consolidates CRO Study Assets into One Archive/Repository Solution

Challenge

A Top 25 biopharmaceutical company was using various external contract research organizations (CROs) to conduct GLP studies in order to support product development and new drug candidate submissions. After over 15 years of conducting these studies, sample archiving and storage bills were coming in almost weekly from the various CROs, creating several challenges:

COSTS: Once compiled, the company determined it was spending over $1.2 million per year on the storage of samples, specimens, and data related to its GLP studies.

COMPLEXITY: Assets scattered across different CROs and Biostorage vendors led to dozens of different inventory formats, listings, and storage processes.

QUALITY: Highly valuable intellectual property spread across various Biostorage facilities meant that the assets were maintained using different systems, controls, and procedures, resulting in a decrease in overall quality and additional burden for the company when auditing vendors for compliance.

With the company conducting more and more studies to support its growth, what could be done to reverse the amassing complications in managing the delicate assets produced by these studies?

Solution

The straightforward answer was to simplify. Instead of dealing with multiple organizations and the unpredictable variables that came with them, the company sought to narrow its network of biostorage facilities and streamline the process of managing them. To this end, EPL Archives was able to provide a consolidation solution to the company that resulted in all study-related assets being transferred to a single purpose-built, secure biorepository, thereby centralizing the company’s point of contact and inventory listings for its various samples, specimens, and data.

EPL’s process of consolidating samples provided the utmost care in transferring the assets between storage facilities, while working within the variety of billing cycles from the other CROs and storage vendors. Going forward, the company instructed current CROs to transfer materials directly to EPL Archives within protocols on study design, ensuring that a suitable plan-of-action was already in place for decisions that could occur years from a study’s start.

Result

In addition to streamlining inventory listings and vastly simplifying the asset management process, the company was able to reduce annual storage spend by 82% – a total savings of almost $1 million (USD). As a result of this positive experience with handling GLP materials, the customer went on to refer EPL to its clinical trials group and is actively migrating clinical samples to EPL facilities -- resulting in even more savings and reduced complexity.

Biorepository cost savings with implementation of EPL Archives solution total costs dropped from -$1.2 million in year 1 to -$200K in year 4

Do you use multiple CROs? If so, please contact Avantor Services to see if a consolidated approach can improve quality, reduce risk, and save your company time and money.