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Nanobiotix half year results for the six months ended 30 June 2016

Nanobiotix releases financial information for the six months ended 30 June 2016, complete with updated shareholder composition
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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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CPhI Worldwide 2016

4-6 October 2016,

The world’s leading pharmaceutical platform CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 36,000 visiting pharma professionals over three days. 2,500+ exhibitors from 150+ countries gather at the event to network and take advantage of more than 100 free industry seminars. Every sector of the pharmaceutical market is represented under one roof, this year in a new location in Barcelona. Attending CPhI Worldwide is the most cost effective way to establish new business relationships, meet with global partners and stay updated on the latest industry trends.
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