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.
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 responded to the client’s needs by providing Oracle certified Clinical One specialized consultants, who had expertise in both computer systems validation and clinical data management domain knowledge. Key aspects of the project included:
- System Requirements Gathering: Techsol’s team worked closely with the client’s personnel to collect system requirements for implementing the next-generation Electronic Data Capture (EDC) application. To meet the urgent business requirements, three full-time equivalent (FTE) resources from Techsol collaborated with the client’s team.
- Installation Qualification: Oracle completed the installation qualification of the Clinical One application for the client, as it was a cloud-based solution. Our team ensured that all the key validation documents provided by Oracle were verified and accounted for regulatory compliance.
- Configuration & Validation: Techsol undertook the essential tasks of configuring and validating the Clinical One application in adherence to the client’s validation standard operating procedures. All validation documentation was authored, executed, reviewed, and approved by adhering to the industry recommended GAMP 5 validation methodology.
- Process Gap Analysis & New SOP Development: A comprehensive gap analysis was performed to ensure that system configurations were in alignment with the newly developed SOPs and work instructions. Given the absence of readily available SOPs, Techsol team drafted the necessary SOPs aligned with industry best practices for executing the client’s clinical data management process using the Clinical One application.
- Training and User Acceptance Testing: Techsol’s SMEs delivered hands-on application training to the client’s team, enabling them to execute Performance Qualification/User Acceptance Testing (PQ/UAT).
The collaboration between Techsol and the client resulted in significant achievements:
- Effective Coordination: Techsol established seamless coordination with client’s Clinical Operations, Digital and Process Excellence (DPEX), Quality Assurance (QA), and Validation departments. This collaboration streamlined the project, ensuring that every department’s requirements were met.
- Zero Execution & Process Errors: The project was executed without any errors, ensuring a smooth implementation of the Clinical One application. Techsol’s team of consultants had hands-on experience on both the Clinical One application and the Clinical Data Management process which eliminated process errors and validation execution errors.
- IQ Documentation: Installation Qualification (IQ) documentation was provided by Oracle, given the nature of the application which was delivered using the Software as a Service (SaaS) model.
- OQ Documentation: Our team had leveraged our validation accelerator package which had readily defined Operational Qualification (OQ) test scripts for the Clinical One application. This resulted in a 40% time reduction for the client, helping them to achieve their planned timeline for system rollout.
- PQ/UAT Scripting & Execution: With our certified Clinical One Consultants, we authored the PQ/UAT scripts that were aligned to the newly drafted SOPs, enabling the client to seamlessly execute the User Acceptance Testing. Our team was readily available to support users for completing the UAT execution.
- Cost Reduction: With a remote project engagement model and readily available validation accelerators, the client experienced an impressive 45% reduction in the overall Clinical One implementation and validation costs. By transitioning to in-house capabilities and optimizing their systems, the client achieved substantial cost savings.
- Regulatory Compliance: Techsol followed the GAMP 5 Risk-based validation approach, ensuring that the client achieved 100% compliance with FDA’s 21 Part 11 and EU Annex 11 regulatory requirements. This provided accountability on the data integrity of all electronic records and validity of executed electronic signatures that were correctly reflected in the audit trail.
Conclusion:
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.”