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Industry Events

IRT Europe Summit

10-11 April 2018, The Hotel Brussels, Belgium

New clinical trial regulations are requiring sponsors to keep tighter oversight than ever before – from audit trails to tracking system changes – resulting in high costs and trial delays. IRT Europe explores implementation best practices and how interactive response technologies can be utilised to improve supply chain planning and optimise clinical trials.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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News and Press Releases

Charles River Laboratories Makes Investments in High-Throughput Screening Infrastructure

WILMINGTON, Mass.--(BUSINESS WIRE)--Feb. 1, 2018-- Charles River Laboratories International, Inc. (NYSE: CRL) today announced a new agreement which grants Charles River commercial access to AstraZeneca’s (NYSE: AZN) high-throughput screening (HTS) and compound management infrastructure. Through the agreement, Charles River will perform HTS programs for its clients utilizing AstraZeneca’s state-of-the-art HTS facility.
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