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Spring 2013

   
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News and Press Releases

Arcis Biotechnology appointments Professor Steve Howell as Non-Executive Chairman

Daresbury, UK, 24 July 2019: Arcis Biotechnology (“Arcis”), the nucleic acid sample preparation solution provider, today announced it has appointed Professor Steve Howell as Non-Executive Chairman of its Board of Directors. Steve takes over the position from Paul Foulger, who was serving as Chairman on an interim basis on behalf of the Board.
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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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Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
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