Berlin, Germany, March 28, 2013 --(PR.com
)-- 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
CDISC® is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC® mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC® standards are vendor-neutral, platform-independent and freely available via the CDISC® website.
ICRC-Weyer is an established all-phase contract research organization (CRO) based in Berlin, Germany. The company was founded in 1993 by Prof. Dr. Geerd Weyer and offers services ranging from pre-clinical through to phase IV clinical trials. ICRC-Weyer provides complete turnkey solutions including data management, monitoring and medical review services for all stages of the clinical development process.
ICRC-Weyer has special expertise in Advanced Therapies, Nutrition, CDISC® Data Standards and Medical Review.