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RoslinCT to Participate in the Northern Alliance Advanced Therapies Treatment Centre

RoslinCT, a UK-based cell and gene therapy contract manufacturing organisation, is delighted to be part of the Northern Alliance Advanced Therapies Treatment Centre (NAATTC) consortium. As an industry partner within the consortium, RoslinCT will provide advice on the development, manufacture and clinical supply of cell, gene and tissue engineered therapies.
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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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SMi presents the 13th Conference on ADMET

9-10 July 2018, Holiday Inn Kensington Forum, London, UK

SMi is delighted to announce the 13th annual ADMET conference returning to London to explore the optimisation of ADMET modelling techniques, preclinical DMPK applications and development of biopharmaceuticals.
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