The STUDY COMPOSER is a user-friendly tool that claims to create harmonious and efficient teamwork for producing the CRF and data validation plan, both for Study Managers and Data Managers and in doing so to save a CRF design on the basis of the CDSIC ODM standard.

In the conventional work process, various team members create various Word and Excel documents, which often exhibit discrepancies, both amongst each other and when compared to the database specification of the programmers. These discrepancies have to be manually compensated for, which takes time and effort.

In the new, harmonious process based on a solution like the STUDY COMPOSER, all the team members use only the STUDY COMPOSER instead of Word or Excel. Everyone works on the same page, many of the documents required are generated automatically and are therefore automatically consistent with each other at all times. This makes the collaboration truly efficient and save a lot of time and energy.

If you use an EDC system which is certified for the import of CDISC ODM metadata, the new procedure achieves a maximum increase in efficiency: the programming of the database and the trial-specific EDC system validation can be omitted without replacement because the EDC system based on the CRF design provided by the STUDY COMPOSER in the CDISC ODM format is configured completely automatically.

To learn more about the STUDY COMPOSER, » click here.