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.
The client previously outsourced their clinical operations and clinical data management to Contract Research Organizations. The company decided to bring these critical clinical development processes in-house. As part of this strategic shift, they procured Oracle’s Clinical One System for executing the end-to-end clinical data management processes in-house using their team members. The client had the following challenges to successfully complete the implementation and validation of this new system:
- Limitation on Application Knowledge: To implement and validate Oracle’s Clinical One application, the client did not have a talent pool who had both application knowledge and business process expertise for timely completing the rollout of this new system to support their clinical data management operations.
- Lack of Configuration & Validation SMEs: Due to a shortage of trained Subject Matter Experts (SMEs), the client faced difficulty in configuring the Clinical One application to suit their business process needs before validating it for regulatory compliance.
- New Process Documentation: Although they had quality policies and procedures in place, there was a pressing need to develop new Standard Operating Procedures (SOPs), Policies and Procedures (POLs), and work instructions for effectively using the Clinical One application.
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.
“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.”