spacer
home > ict > winter 2018 > promoting patterns
PUBLICATIONS
International Clinical Trials

Promoting Patterns

The clinical trial industry is transforming, and the vision for this is simple: embrace quality and automation across the clinical trial spectrum and move closer to zero-delay trials. Why? It provides better, faster results, offers more information for sponsors, allows more innovation for CROs, and, most importantly, presents expedited outcomes for patients in need. This transformation is just beginning and requires that we challenge ourselves, our teams, partners, and clients – the entire clinical trial industry – to work smarter and eliminate preventable delays.

Data Dilemmas

Drug or device trials are fundamentally science experiments. Everyone has some familiarity with how that works from those exciting high school or college labs where one measured some Newtonian physics principle. However, unlike those, in clinical trials, the outcome is unknown, and the data are never as crisp and predictable. For the most part, the signalto- noise ratio is exceedingly small. If the data collection or the analysis processes adds more noise to the system, the signal may become undetectable. When that happens, therapies that might have helped patients in need may never be approved because the data was not handled appropriately.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Abraham Gutman founded AG Mednet in 2005 and leads the company’s mission to improve, automate, and expedite outcomes in clinical trials by ensuring quality and compliance within drug, biologic, and device trials. Abraham holds a BA in computer science from Cornell University and an MSc in computer science from Yale University, US.
spacer
Abraham Gutman
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

WuXi AppTec Completes Acquisition of OXGENE to Further Strengthen Cell and Gene Therapy Service Offerings for Global Customers

PHILADELPHIA and OXFORD, March 2, 2021 - WuXi AppTec, a leading global provider of R&D- and manufacturing-enabling services in the pharmaceutical, biotechnology and medical device industries, today announced that it has completed the acquisition of OXGENE, a pioneering United Kingdom-based contract research and development organization that designs and develops scalable gene therapy technologies. This acquisition enables WuXi AppTec to offer its customers end-to-end support in the creation and development of cutting-edge cell and gene therapies for patients in need worldwide.
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 >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement