Challenges in Implementing CDISC & CDASH Standards in Oracle Clinical RDC by Quyen Nguyen

www.innoventz.com

A standard database structure using the CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data. According to the PhRMA-Gartner-CDISC project, there is a per study cycle time reduction of 8.1 months and a per study cost savings of $9 million, when standards are implemented in the study startup stage. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials.

There are some challenges in implementing CDISC in EDC:

1. Key personnel in companies must be committed to implementing the CDISC/CDASH standards.

2. There is an initial cost for deployment of new technology: SDTM Data Translation Software, Data Storage and Hosting, Data Distribution and Reporting Software.

3. It can be difficult to understand and interpret complex SDTM Metadata concepts and the different implementation guides.

4. Deciding at what point in a study to apply the standards can be challenging: in the study design process, during data collection within the CDMS, in SAS prior to report generation, or after study completion prior to submission.

5. Data managers, biostatisticians, and clinical monitors may find it difficult to converge on a new standard when designing standard libraries and processes.

6. Implementing new standards involves reengineering internal processes and SOPs.

7. Employees must be retrained on the use of new software and CDISC/CDASH standards.

8. There are technical obstacles related to implementation in Oracle Clinical (OC), including 8 character limitations on numerous variables, determining when to use supplemental qualifiers versus creating new domains, and creating vertical data structure.

Innoventz, a California based CRO can help to manage the transition of your clinical trial to CDISC compliant data standards. Innoventz is a part of the CDISC Medical Device Sub-team and the CDASH Project. We are well informed of the new standards and changes to be released and we can help demystify the guidelines, standards, and processes for your company. Using the powerful engine of Oracle Clinical, Innoventz has developed a CDISC compliant standard study design that takes advantage of the benefits of CDISC standardization: decreased study start-up and design time, increased data quality, decreased data redundancy, improved data integration, enhanced scalability and re-usability of global library infrastructures in our Clinical Data Repository, facilitation of data interchange and inter-operability with external vendors, decreased time to FDA submission and cross-communication and review of regulatory submissions. A complete CDISC compliant study design and CRF set will save you time and money from study design, data collection, data exchange, data review, data analysis, data submission to data archival.

Innoventz, a full service CRO, offers data management services as well as customized software solutions. This expertise paired with an acute understanding of the CDISC/CDASH initiatives makes Innoventz an ideal partner for your data management needs.

For more information on the benefits of CDISC and CDASH and what Oracle Clinical can provide for your clinical trial, please visit us at www.innoventz.com or email us at info@innoventz.com.