Company
A Fortune 50 Company known as a leading global manufacturer of health care products and services for the consumer, pharmaceutical and professional markets.
Business Need
The company conducts clinical trials through the use of multiple internal and external systems. Ascendum was contacted by the company to assist in creating a solution based on CDISC/ODM standards that would integrate multiple vendors' databases with internal systems. The primary objective of the system was to optimize the integration of internal and external databases in order to shorten trial cycles, and increase the quality and reliability of trial data.
Solution
Ascendum recommended and implemented integration of the in-house system with the EDC Vendor database applying the CDISC standard ODM. This eliminated manual intervention, shortened clinical trial cycles and increased data quality. Ascendum set up a unique global deployment model consisting of judicious on-site project management coupled with off-shore resources of highly qualified technical engineers. Additionally, Ascendum represented the client on the industry standards body and added substantial value by providing guidance in the implementation of pharmaceutical and IT standards.
Technologies Used
Java, J2EE, Servlets, Visual Basic, XML and Oracle
Benefits / ROI
- Ascendum has successfully implemented a solution which is compliant with CDISC/ODM standards. Our Client leads the industry in CDISC/ODM standards compliance.
- Our Client achieved over 64% cost savings in solution implementation due to on-site and off-shore expertise.
- Efficiencies gained in system performance enables our Client to realize tremendous time and cost savings for every clinical trial conducted.
- Continuing to Grow in Quality, the Client - Ascendum team is now designing, developing and supporting the Client's CDISC standard ODM based corporate-wide initiative to ensure near real time availability of data.
