The report suggests most clinical supply organizations use two main strategies to achieve timely and accurate delivery of clinical materials to the study subjects: the use of outsourced vendors for the execution of some or all of the clinical supply activities; or an information management system designed to initiate, control and track clinical supply activities through the supply chain.
However, the report concedes that although most organizations employ these methods, many face difficulties when integrating them together. And the challenge doesn'st stop there. The clinical supply chain is becoming increasingly complex as clinical materials move between sponsors and Clinical Supply Service Providers (CSSPs), all of whom have their own information systems to control such activities.
A comprehensive information integration strategy needs to be developed in order to be able to trace these movements through the entire chain, the report suggests. An integration strategy is necessary in order to control the execution of activities at all locations, maintain accountability of product as well as for financial tracking and planning reasons. It is also important to develop a strategy to set a framework for all future relationships with CSSPs.
The report proposes an efficient integration strategy will enable organizations to minimize the difficulties involved in adding new vendors, but warns that companies should develop a strategy that incorporates a number of elements, from creating data flow charts and visions of what outputs are needed, to assessing current systems and practices and providing flexibility for future activities.
As a conclusion, the report suggests it is the sponsor who is ultimately responsible for the conduct of clinical trial activities and their successes.
It is imperative for the sponsor to have a strong information management system to control all aspects of the clinical supply chain to ensure accountability and control throughout the entire process, the report concludes. As more and more clinical supply activities are outsourced, it is important to have a strategy in place to track and control these in the sponsor's clinical supply system. A flexible clinical supply system that has built-in abilities to interface with other systems and maintain data integrity is a key factor in the success of a clinical supply organization in this growing and ever changing field.
To view the Integrating Clinical Supply Systems & Outsourced Service Providers report in full, click here
You can learn more about how your company can benefit from clinical outsourcing and how strategic alliances and partnerships can increase your pipeline productivity at eyeforpharma's upcoming conference, Collaborative Strategies in R&D Europe, 2-4 December 2002, Amsterdam. Click here for full details.
For more information on speaking or sponsorship, please contact Event Director, Sebastien Rooryck on Tel: +44 (0) 20 73 75 75 51 or Email: sebastien@eyeforpharma.com.
