D&O Deploys Oracle Clinical
By Julia Fernandes
Mumbai, Dec 15, 2004

In an effort to speed the automation of the clinical trial process, Mumbai-based D&O Clinical Research Organization, has deployed Oracle Clinical- a comprehensive clinical data management solution.

Typically, clinical data management involves processes like capturing data (from various test reports over a period of time), cleaning, analyzing, validating the data, and then entering it into the legacy applications. Even though D&O accomplished these tasks, the company had to encounter several challenges.

The research organization used to spend considerable time on designing and developing the database (single data entry), manually verifying the entries, generating queries, getting queries resolved from the sites and then completion of the report.

Speaking to CXOtoday, Nikhil Varma, manager- IT support services, D&O Clinical Research Organization, said, "With the deployment of Oracle Clinical, the validation time has been significantly reduced as there does not involve client side installations. Moreover, the strong remote data capture feature enables entries from remote site easier and faster."

Summarizing the factors that titled in favor of Oracle, Girish Virkar, CEO, D&O Clinical Research Organization, said, "The fact that the software is fully compliant with 21CRF Part11 guidelines is very essential to ensure that the data captured in the database is thoroughly auditable. Secondly, the timely service support from Oracle is very vital as when a project requires any technical support, the vendor should be available to address the issues."

The suite includes remote data capture for entering and managing data from the investigative site, thesaurus management system for classifying investigator terms against medical dictionaries, and the adverse event reporting system for managing product safety.

According to Varma, the solution was deployed in a phased manner. Says Varma, "Initially all the modules were implemented on a single server. In the second phase, we distributed the same on three different servers as per Oracle architecture. While the first phase took around seven days, the second phase which is currently on and which involves system validation and documentation is expected to last for another three months."

The solution deployed across five users sits on Oracle 9.2.0.3. At the server level, Windows 2000 Advanced server is being used while Windows 2000 Professional adorns the clients.

D&O is a contract research company engaged in the field of R&D and custom synthesis for more than a decade.