Partnerships in Clinical Trials Europe 2018

27-29 November 2018, CCIB, Barcelona

Partnerships in Clinical Trials Europe is back – and bigger than ever. Europe’s most complete clinical meeting is bringing together 1000+ of the industry’s leading experts this November for it’s 17th annual gathering, and you’re invited!
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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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BioIVT Acquires UK-based Clinical Trials Laboratory Services

BioIVT, a leading provider of research models and services for drug development, today announced that it has acquired Clinical Trials Laboratory Services (CTLS), a donor center and laboratory based in London, UK. CTLS provides dedicated high-quality serum, plasma and blood collection services. It also offers full-service cell processing capabilities on site.
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