CDISC

The Clinical Data Interchange Standards Consortium (CDISC) has introduced a standard set of tools to the ever expanding, atypical clinical data industry:

• Lead the development of standards that improve process efficiency, while supporting the scientific nature of clinical research

• Recognise the ultimate goal of creating regulatory submissions that allow for flexibility in scientific content – to be easily interpreted, understood and navigated by regulatory reviewers

• Acknowledge that the data content, structure and quality of the standard data models are of paramount importance, independent of implementation strategy and platform

• Maintain a global, multidisciplinary, cross-functional composition for CDISC and its working groups

• Work with other professional groups to encourage maximum sharing of information and minimum duplication of efforts

• Provide educational programmes on CDISC standards, models, values and benefits

• Accomplish the CDISC goals and mission without promoting any individual vendor or organisation

The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability – improving medical research and related areas of healthcare.

The Cmed Approach: Timaeus

Timaeus captures data into an hierarchical database (with full data management capabilities inherent within the system) – this combination is unique within the industry. CDISC is an hierarchical data model: consequently mapping ODM metadata to Timaeus configuration is technically straightforward.

Converting relational databases to hierarchical models is complicated and time consuming, as many of our clients have previously discovered.