spacer
home > ict > summer 2007 > the happy couple
PUBLICATIONS
International Clinical Trials

The Happy Couple

Katrien Vermeiren of SGS Life Science Services explores the relationship between EDC and CDISC – the perfect combination for successful submission

Since electronic data capture (EDC) has become a valid alternative to paperbased trials, we are frequently confronted with the problem of trial-specific database structures, which are inherent to EDC. The lack of regulated standards makes inter-departmental and inter-organisational collaboration difficult. A standard database structure, as prepared by the submissions data standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC), would certainly facilitate the collection, exchange, reporting and submission of clinical data. Ideally, the EDC provider would deliver a standard structure. However, SDS interpretation differences, the impact of database structure changes on the eCRF and the increasing amount of work upfront are important objections to this approach. Leaving the SDS conversion up to the sponsor or CRO seems the best solution – a close collaboration between the EDC provider and the sponsor or CRO should be encouraged.

ELECTRONIC DATA CAPTURE

EDC has been proven to reduce the cost of clinical research studies by improving quality and reducing the time to database lock. It can also accelerate the development time of a particular drug (1).

EDC enhances the visibility of clinical data, resulting in better data control and making faster interim analysis possible. The system enables companies to dynamically modify the management of allocated resources and trials. Moreover, EDC also seems to be a promising system for accurate operational metrics (2), which in turn helps to reduce the time-to-market and the cost of new medications.

With these benefits in mind, one can overlook the need to investigate the problems inherent to EDC. Ad hoc and informal trial specification methods, coupled with the lack of standardised data interchange formats, mean that study set-up and execution will continue to be problematic, timeconsuming and expensive. The lack of globally accepted pharmaceutical data formats is believed to cost the pharmaceutical industry in excess of US$156 million per annum (3).


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
4
     

There are no comments in regards to this article.

spacer
Katrien Vermeiren is Programming and Data Entry Manager within the biometrics department at SGS. Prior to joining SGS, Katrien Vermeiren worked at Janssen Pharmaceutica as a Clinical Data Co-ordinator in the oncology field, and as a Data Reviewer at MSI (now SGS). With three years of data review experience, she joined the programming group as Data Manager, where she mastered the relevant data management skills. As well as her Programming and Data Entry Manager activities, Katrien now focuses on implementing EDC technology within SGS.
spacer
Katrien Vermeiren
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

MedPharm’s CSO and University of Reading Professor co-author new book on dermal formulation development

MedPharm’s Chief Scientific Officer and Co-Founder, Professor Marc Brown and University of Reading’s Professor Adrian Williams have co-authored the new book: ‘The Art and Science of Dermal Formulation Development”. It is the latest addition to ‘Drugs and the Pharmaceutical Sciences’, a series of textbooks and monographs published by CRC Press.
More info >>

White Papers

Keeping Abreast of the Competitive Environment in Clinical Development

Thomson Reuters

Strategic management of a therapy area requires hard decisions to be made about which programs to invest in and which to let go. Understanding the rapidly changing competitive environment for your drug candidates is a key input into these decisions. It is easy to lose track of the broader picture when a clinical program is in progress and get blindsided by external events.
More info >>

 
Industry Events

PDA Europe Annual Meeting 2019

24 June 2019, Hilton Amsterdam

Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement