XClinical GmbH, a European vendor of innovative software products for e-clinical trials, successfully passed the ODM certification process. The Clinical Data Interchange Standards Consortium (CDISC) announced today at the “CDISC European Interchange” in Montreux, Switzerland, that MARVIN will be the first EDC-CDM software suite to receive the official certification logo for full compliance with the Operational Data Model (ODM).
The ODM certification program was introduced by CDISC during the Interchange in Bethesda, Washington, in September 2006. Independent and thorough testing procedures warrant that the certification ensures full compatibility of software products with the ODM structure which allows the easy exchange of data between different applications in the e-clinical process.
“We are very proud to receive this certification logo.” states Dr. Philippe Verplancke, Managing Director of XClinical: “The use of data standards is our major development principle; when we started to develop MARVIN back in 2002, it was absolutely clear that we would build the product on the CDISC Operational Data Model. Not only as an import or export interface, but using the ODM structure to automatically generate the e-CRFs, the database structure and the query logic. The benefits are obvious: First of all, it allows a very straightforward and extremely fast set-up of an e-clinical trial. Second, as MARVIN is just one piece in the e-clinical chain, strict usage of data standards allow our clients to efficiently work with different applications and service providers up to transmission of data to the regulatory authorities. And, last but not least, the whole set of CDISC data standards enable our customers to establish data dictionaries that are independent from single applications. All this generates a strong, positive business impact concerning the duration and costs of clinical development.”
XClinical participates in the “CDISC End to End” workshop during the European Interchange in Montreux to demonstrate, together with other software vendors, the data compatibility between different applications.
For further information about our products and services, please visit us at CDISC European Interchange in Montreux on April 25 / 26 at Booth 11, or contact our Business Development Team: Karola Rohlff, phone +49 (0)89 45 22 77 – 52 20.
The ODM certification program was introduced by CDISC during the Interchange in Bethesda, Washington, in September 2006. Independent and thorough testing procedures warrant that the certification ensures full compatibility of software products with the ODM structure which allows the easy exchange of data between different applications in the e-clinical process.
“We are very proud to receive this certification logo.” states Dr. Philippe Verplancke, Managing Director of XClinical: “The use of data standards is our major development principle; when we started to develop MARVIN back in 2002, it was absolutely clear that we would build the product on the CDISC Operational Data Model. Not only as an import or export interface, but using the ODM structure to automatically generate the e-CRFs, the database structure and the query logic. The benefits are obvious: First of all, it allows a very straightforward and extremely fast set-up of an e-clinical trial. Second, as MARVIN is just one piece in the e-clinical chain, strict usage of data standards allow our clients to efficiently work with different applications and service providers up to transmission of data to the regulatory authorities. And, last but not least, the whole set of CDISC data standards enable our customers to establish data dictionaries that are independent from single applications. All this generates a strong, positive business impact concerning the duration and costs of clinical development.”
XClinical participates in the “CDISC End to End” workshop during the European Interchange in Montreux to demonstrate, together with other software vendors, the data compatibility between different applications.
For further information about our products and services, please visit us at CDISC European Interchange in Montreux on April 25 / 26 at Booth 11, or contact our Business Development Team: Karola Rohlff, phone +49 (0)89 45 22 77 – 52 20.
