Implementation and Validation of a Cloud-based Clinical Data Management System for a Leading Pharmaceutical Company

Implementation and Validation of a Cloud-based Clinical Data Management System

About Client:

Our client, a top 5 Indian pharmaceutical company headquartered in Hyderabad, India, specializes in the development, manufacturing, and distribution of various generic formulations, active pharmaceutical ingredients (APIs), biosimilars and proprietary products. The company’s generic products are indicated for the treatment of gastrointestinal disorders, various cancer types, pain, cardiovascular diseases, central nervous system disorders, infectious diseases, and pediatric diseases.

Operating in over 100 countries, they are committed to improving global healthcare access, promoting innovation, and enhancing patient well-being.

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Techsol’s validation expertise and collaborative team effort resulted in the successful implementation of Oracle’s Clinical One application for the client empowering them to establish their in-house clinical data management operations. The collaborative development of new SOPs and work instructions for using the Clinical One application was a key learning for Techsol as it involved multiple discussions with various stakeholders from the client side. With this success, the client has now entrusted us to provide application support after Go-Live to ensure business continuity.

Client Testimonial

“Our decision to bring in-sourcing was driven by the desire for greater control, efficiency, and the ability to tailor our processes to meet the specific needs of our clinical trial programs. This milestone is the culmination of months of meticulous planning, hard work, and collaboration across teams. We would like to give a special shout out to Techsol team members for their exceptional contributions, hard work, and support in timely completing the Clinical One systems validation and CDM process development.

The successful go-live of Clinical one sets a high standard for the continued phases of this initiative and have full confidence that our dedication and collaborative spirit will carry us forward to accomplish our business goals around clinical data management.”

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