KCL-00001528 King's Clinical Trials Unit (KCTU) Electronic Data Capture System Requirements

King's College London is looking to procure an Electronic Data Capture System (EDC) with integrated ePRO functionality, in response to the evolving landscape of clinical trials management and technology. Spearheaded by the KCTU (King's Clinical Trials Unit), this initiative is driven by the need to ensure business continuity, enhance efficiency, and maintain the confidence of academic researchers and external partners.

The KCTU has significantly expanded its portfolio of clinical trials since the adoption of its current EDC system in 2005. From a mere three studies, the KCTU now supports over 130 concurrent studies, with approximately 100 utilizing the EDC system. As the volume and complexity of trials have grown, the KCTU seeks a system that offers not only regulatory compliance but also advanced features, including direct patient data entry modules and optimal data export formats.

The decision-making process involves careful consideration of factors such as prospective study setup, seamless migration, regulatory compliance, user-friendliness, and overall system cost. The procurement is critical not only for KCTU's operations but also for sustaining King's College London's reputation as a leading research institution. The new EDC system will be instrumental in upholding the university's commitment to transformational research, maintaining research momentum, and supporting the academic pipeline. The introduction of an advanced EDC system is expected to have widespread benefits. From enhancing research efficiency and maintaining business continuity to ensuring regulatory compliance and delivering improved customer service, the system's impact will resonate across researchers, trial managers, administrators, IT teams, and external stakeholders. This initiative aligns with King's College London's strategy to uphold its position as a research leader by providing cutting-edge tools and services that empower researchers and drive impactful results.

Please note an included set of Pass/Fail Requirements as part of this ITT, which each Bidder must adhere to, incl.:

• The solution's licencing must NOT be based on the number of system users and, therefore, the system must be based on an 'unlimited user' model, without a Cost implication for the University.
• The Supplier's proposed solution must be an off-the-shelf product with NO required bespoke set-up and/or configuration.

Additional information: Is a Recurrent Procurement Type? : No