March 26, 2013 -- As part of a continuous growth process, ICRC-Weyer has added further members to its data management team enabling the company to meet the increasing demand for a complete range of services for phase I-IV clinical trials as well as post-marketing studies. In addition, the company has recently joined the Clinical Data Interchange Standards Consortium (CDISC) on a gold-level membership.
For several years now, the company has been working compliant to CDISC standards in data management and biostatistics. This includes the development of template case report forms based on CDASH*, the preparation of the Case Report Tabulation Data Definition Specification (define.xml), mapping specification based on study protocol and CRF according to the latest SDTM* version as well as the definition and creation of study specific analysis datasets according to ADaM*.
‘We have been implementing studies according to the various CDISC standards for quite some time now.’ says Deborah Severin, Head of Data Management at ICRC-Weyer. ‘And we have been following news and updates about the development of these standards as part of the local German CDISC User Group. In order to actively promote and contribute to this development, we have decided to join CDISC on a gold-level membership. This enables us to exchange views with other CDISC members, review drafts and give constructive feedback for the implementation of new data standards.’
ICRC-Weyer can now benefit from accessing new documentation that supports the implementation of CDISC standards (e.g. the CDASH user guide), CDISC case studies and other useful tools and information such as archived webinars and ADaM validation checks. A membership also allows for participation in CDISC’s licensed training programs.
‘Especially beneficial to us are the training programs and the related material which we intend to use for internal trainings of our data management staff.’ Ms Severin continues. ‘This and all the other benefits enable us as a clinical research organization to continuously improve our data management processes and therefore contribute to standardized and streamlined submission guidelines that ultimately improve the quality of data in clinical trials.’
CDISC furthermore organizes regular events such as the annual CDISC Interchange conferences. The upcoming European Interchange will take place in Frankfurt, Germany, 22-26 April 2013, which ICRC-Weyer will also attend.
*CDASH = Clinical Data Acquisition Standards Harmonization
*SDTM = Study Data Tabulation Model
*ADaM = Analysis Data Model