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Spring 2018

   
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News and Press Releases

3P Biopharmaceuticals welcomes Keensight Capital as majority shareholder


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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

ESMO Targeted Anticancer Therapies Congress 2020

2-4 March 2020, Paris, France

A unique and international mix of experts, researchers and decision makers both from academia and industry across the globe, will convene in Paris for a three-day Congress aiming at exchanging knowledge, experience and research innovations in cancer. TAT 2020 will focus, among others, on novel strategies in immuno-oncology, personalised medicine and molecular tumour boards, preclinical studies to identify effective combination therapies, use of microbiome, tumour agnostic trials, ADC technology, oncolytics, multispecific biological constructs and targeting cytokines. Participating in TAT 2020 will offer you the possibility to take part in interdisciplinary discussions inspiring new ideas and new collaborations.
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