Revolutionizing Clinical Protocol Design by streamlining Research and accelerated approvals with insight-driven Solutions
Overview.
The pharmaceutical industry constantly grapples with inefficiencies in protocol design, development, and approval processes. Our customer is a prominent player in the pharma sector, facing significant challenges due to outdated standards and disjointed processes. Our domain expertise in healthcare and a robust Go-To-Market (GTM) solution aimed to address these issues, providing customer with a streamlined, data-driven approach to clinical research.
The customer is seeking to tackle a multi-billion-dollar problem in clinical trials that is compounded by disjointed processes, siloed research, manual authoring, and delayed feedback.
Protocol management relied heavily on word documents and email communications, leading to inefficiencies and errors.
Research and data insights for trial design were fragmented and isolated.
The manual process for protocol authoring was time-consuming and prone to delays.
Feedback from regulatory authorities was often delayed, slowing down the approval process.
85% of clinical trials fail to recruit enough patients.
3-6 Months average time to draft and finalize the protocol.
2.1 - The average number of substantial protocol amendments = $1.2 million to the overall cost of each study
Solution
Coforge enhanced the IDP solution on the Pega Launchpad platform by ensuring necessary functionality is established, enhanced, and maintained to better position customer’s platform to secure sales of their digital protocol solution. Key activities included:
Roadmap Consulting: Outlined a clear roadmap for transitioning to an integrated protocol design process.
Rollout Feedback: Analyzed feedback from initial rollouts to optimize the implementation strategy.
Scheduler Activity Mapping: Developed a tool to visualize and manage scheduler activities.
Workflow Review: Identified bottlenecks and areas for improvement in existing workflows.
Quality Engineering for Protocols: Ensured high standards in protocol design and execution.
Enhanced clarity and organization by differentiating procedures according to specific activities.
Protocol Comparison: Developed tools for comparing protocols, aiding in better decision-making.
One-Layer Data Integration: Established a unified data integration layer to support insight-driven clinical development.
Dedicated Support for client integration and implementation
The Impact
Starting with insights, data capture, and streamlined workflows, protocol efficiencies increased significantly.
Leveraged insights in clinical trial design and execution using a low-touch tech-stack, enhancing research quality and speed.
Provided data to contextualize clinical findings, improving accuracy and relevance.
Fostered genuine cross-team collaboration, breaking down silos and ensuring seamless communication across departments.
