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PHARMACEUTICAL INDUSTRY EVENTS CALENDAR

Outsourcing in Clinical Trials Medical Device USA 2018

Arena Outsourcing in Clinical Trials Medical Device USA 2018

11-12 July 2018
Minneapolis, Minnesota

6th Outsourcing in Clinical Trials conference is the only clinical outsourcing platform for medical device companies within Medical Alley this year.

Develop the effective outsourcing strategies to ensure timely and cost-effective clinical studies. Be responsive to the industry trends and enable an early market penetration.

This conference offers great opportunity for delegates to network with industry professionals and service providers, as well as attending insightful lectures from experienced clinicians in the Minnesota area.

Register for a complimentary pass with the code MK-VA or contact us to events@arena-international.com

Website: www.arena-international.com/omdt/

phone +44 (0)207 936 6400
email events@arena-international.com
web www.arena-international.com/omdt
email Minneapolis, Minnesota
 
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Industry Events

SMiís 9th Annual Biosimilars & Biobetters Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Following the success of our previous events in both London and the US, Biosimilars and Biobetters UK 2018, SMi deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.
More info >>

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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News and Press Releases

Biologics Day

On 20. July 2018, Phenomenex and SCIEX will co-host a full day of seminars, providing solutions for Biologics. The series of mini-seminars presented by technical experts from both companies, will cover methods for characterisation and QC testing, troubleshooting and new trends in analysis for this industry.  
More info >>

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