samedan logo
 
 
 
spacer
home > pmps > winter 2001 >
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer


Rate this article You must be a member of the site to make a vote.  
Average rating:
1
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
News and Press Releases

Europital forecast 30% CAGR from UK biotech for three years

Europital the global provider of medical management services for clinical research and drug development announces it is opening a UK site to further expand its services to the UK biotech industry.
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.
More info >>

 
Industry Events

CPhI Festival of Pharma

5-16 October 2020, Virtual

A virtual gathering for the pharmaceutical industry, the CPhI Festival of Pharma has been created to fill the gap left by in-person events at a time when travel and gatherings are off the cards.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement