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Clinical Insider
Clinical Insider

Industry teams to take on clinical sample management inefficiencies

Posted by on 01 July 2024
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GSK, Moderna, Novartis, Roche and Takeda have joined trial tech firm Slope to develop best practices for the handling of samples from drug studies.

The firms were named as founder members of the Biospecimen Management Consortium (BMC) last week alongside Grail, ILiAD and Teal Health.

According to Slope, the consortium will drive a variety of initiatives aimed at developing best practices and industry standards, streamlining biospecimen lifecycle operations and data management and influencing regulatory policy.

BMC executive director Amy Ripston said "This consortium is the first of its kind dedicated to the nuanced biospecimen-related operational, regulatory, and data management challenges faced in the execution of clinical trials.

"The criticality of this work cannot be understated, and it is imperative that we begin to address existing challenges, so we don't impede scientific advancement."

Anna Kosenko, team lead, Clinical Biomarker Sample & Data Operations, at Takeda said, "The BMC aims to shine a light on the aspects of the process that need to change, and help break down existing siloes among the various stakeholders and systems that drive clinical research."

This was echoed by Xavier Briand, associate director at Novartis, who suggested fragmentation in the CRO space is a source of inefficiency.

"Lack of control and visibility to biospecimen lifecycle and their metadata is a direct result of a clinical ecosystem that is fragmented, siloed, and reliant on people and processes which can still rely on paper-based approaches.

He added: "To drive sample excellence we must unite as an industry to establish a baseline, identify gaps, and challenge the status quo."

The BMC’s first action will be to gauge current practices via an industry survey to “better understand current practices, derived from both qualitative and quantitative metrics.”

The group also invited pharmaceutical or biotechnology organizations to join, adding that, in 2025, membership will be expanded beyond sponsors to include clinical research sites.


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