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European Pharmaceutical Contractor

The Most Important Current and Future Data Management Tasks ahead

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.


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By Anders Hansson, Business and Data Management Consultant at VVTT

Anders Hansson is a Business and Data Management Consultant at VVTT. From 1983-1989, he worked as Clinical Data Manager and Statistician at Pharmacia Diagnostics. In 1989 Mr Hansson joined Kabi-Pharmacia as Clinical Systems Manager, where he was responsible for implementing the corporate CDM system in Sweden, the US and Japan. Mr Hansson was also Systems Manager for the global safety system and Project Manager for the corporate data standardisation project. In 1993 Mr Hansson was appointed Director of Biometrics & Information Systems at Pharmacia in Japan, where he remained for five years. He joined Clinitrac in 2000, working as Vice President of Business Development.

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