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8th Clinical Quality Oversight Forum 2017

11-13 October 2017
Sheraton Philadelphia Downtown Hotel, Philadelphia, PA

ExL’s Clinical Quality Oversight Forum continues to live up to its reputation as an elite gathering of senior-level executives. More>>

 
phone +44 (0) 20 7724 3456
web bit.ly/2tTxggs
email Sheraton Philadelphia Downtown Hotel, Philadelphia, PA
 

Outsourcing in Clinical Trials Nordics 2017

10-11 October 2017
Copenhagen, Denmark

Enabling local knowledge-sharing, benchmarking and network-building between Nordic biopharma and device industry peers More>>

 
web www.arena-international.com/octnordics
email Copenhagen, Denmark
 
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Industry Events

ChinaBio Partnering Forum 2018

25-26 April 2018, Kempinski Hotel Suzhou, Jiangsu, China

Access a world of opportunities through life science partnering in China. ChinaBio® Partnering Forum is the premier life science partnering event in China. The conference will be held April 25–26 in Suzhou, attracting biotech and pharma leaders from around the world along with hundreds of China-based developers of novel technologies for two days of productive partnering.
More info >>

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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.
More info >>


News and Press Releases

Prometic Bioseparations are very pleased to introduce their new purpose built ecommerce platform (Webshop)!

Their goal was to build a platform that is easy to navigate, informative and one that makes their products and services easily accessible to researchers and laboratories worldwide. They also wanted to make ordering as quick and easy as possible to meet the needs of the rapidly progressive industry. They have reflected these requirements with an ecommerce store in order to supply high quality products to customers from academia to big pharma.
More info >>

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