A global biotechnology company developing products to fight disorders of Central Nervous System, our client is conducting trials across the globe working with different CRO’s.
Data of all the trials from phase II to phase IV was managed in Siebel Clinical. Siebel Clinical provides a centralized repository such as essential document tracking, subject visit tracking, investigator payment processing and site visit reporting, financial tracking. Connecting sponsors, CRO’s and investigator sites, improving the visibility, and control over trial operations, Vault eTMF was used establishing a study start up and inspection ready eTMF.
Siebel Clinical doesn’t fully support TMF reference model, sending documents and relevant tasks with in a single package. eTMF system addresses the challenge, but to maintain eTMF system we require basic information from CTMS system to avoid duplication in eTMF system. Techsol was engaged to streamline and automate the data without manual intervention resulting in a quality output.
- Automate the data migration from Siebel Clinical to eTMF system.
- To support the implementation of stream lined data collection process.
- Reducing the effort of data entry by 100%.
Growing number of trials and increase in complexity of the data received from different CRO’s across the globe, company was no longer able to avoid the duplication of data. Techsol with expertise in chosen area analyzed, redesigned and automated the data received.
The Siebel CTMS and eTMF are validated according to their functions. Siebel as CTMS shall build an application to retrieve data from CTMS and make it available for eTMF built Integration Services. Developed the custom SQL to extract data from Siebel CTMS and used Oracle Client, Oracle Data Access Components (ODAC) and MS.NET development User interface application environment to create the application.
Techsol delivered client delight by providing better results than requested by clients. Data entry was automated resulting in significant improvement of the quality of data, hence reducing the time.