|
 |
| home > epc > winter 2003 > the most important current and future data management tasks ahead |
|
|
 PUBLICATIONS |
European Pharmaceutical Contractor
|
For over 15 years the industry has discussed how to improve the process of capturing data in clinical trials. A lot of time and money have been invested in finding better ways of preparing data for high quality analysis immediately after the last patient has completed the trial. Most important are data standardisation and systems for entering data at the clinics, or systems whereby patients enter self-reported data. There are many good examples of that usage, but there are still a few trials not using paper CRFs and traditional data entry. While the requisite data standards are not in place, they could save time and money.
Data Standardisation
Data standardisation is difficult. You cannot standardise too much owing to the nature of clinical trials and the very different therapeutic fields. A total absence of standards causes problems with statistical analysis and complicates and slows down the study set-up. Many companies have quite successfully implemented standards, but all the mergers in the industry quickly destroy this work. In my previous company we spent two to three years defining and implementing data standards. After that the company merged four times, and new standardisation projects have taken place. That's why I very much support the Clinical Data Interchange Standard Consortium (CDISC). It is a good initiative from the industry to define data standards. The CDISC's original purpose was to address the need for data exchange amongst companies, CROs and authorities, but data standards will help large companies internally as well.
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
Industry Events |
 |
Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
More info >> |
|
 |
News and Press Releases |
 |
“PACK DIFFERENT” with EMBALLAGE 2008
“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
More info >> |
|
 |
