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International Clinical Trials

Delivering Breakthrough

One of the most important factors in successfully conducting clinical trials is effectively managing clinical study supplies along the international supply chain. Historically, clinical trials represent the longest and most cumbersome aspect of product development due to the complexity of international studies. Additionally, it has become increasingly difficult to manage the international clinical trial supply chain due to an upsurge in the number of regulatory requirements facing manufacturers both in terms of study design and movement of supplies across borders.

It is often reported that clinical development takes on average six to eight years to complete, absorbing up to two-thirds of a drug’s development budget; thus, much of this spend is typically dedicated to the management of study supplies. One reason for this is that supply management not only requires detailed monitoring, but also the precise planning and coordination of activities from many players, both within and outside the pharmaceutical company itself. Solutions that facilitate collaboration and compliance related to the manufacture and management of clinical trial supplies are critical to reducing time to market, shortening study timelines and reducing R&D costs. In this article, we examine the key challenges facing international clinical trial supply management, and evaluate potential solutions available to pharmaceutical development organisations.

CLINICAL TRIAL SUPPLY CHALLENGES

At the outset of any clinical trial, organisations estimate the demand based on forecasted patient enrolment for each treatment arm and dosing regimen. This demand estimate is used to plan for the amounts of drug products, placebos and comparators, including ancillaries, that are needed. However, this demand formula does not always work.


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Sivakumar Rajagopalan is a Senior Manager at BearingPoint in the life sciences practice. Over the last 24 years he has delivered several large and small ERP, compliance and validation projects for Fortune 100 and SMB companies in North America, Europe, Asia (India and Japan) and the Australian sub-continent. He is credited with the pioneering of right shoring in validation projects, jointly designing a modified GAMP X model and a CSV framework for ERP life cycle. Sivakumar holds an Engineering degree from Shivaji University, India and is currently doing his Masters in Quality Assurance/Regulatory Affairs at the Temple University, PA.

Rebecca Drinkwater is a Senior Consultant in the BearingPoint Life Sciences Practice based in the UK. She has over 10 years’ experience both in the pharmaceutical industry and consultancy to the life sciences sector. Her expertise in the sector is specifically in product development, supply chain, global trade management and change management. Rebecca’s qualifications include a First in Materials and Business Studies from Loughborough University, an MPhil in Process Improvement from Aston University, and more recently she gained her MBA from Cranfield University. Email: rebecca.drinkwater@bearingpoint.com

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Sivakumar Rajagopalan
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Rebecca Drinkwater
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