A new eDC (electronic data capture) system is required by MRC CTU at UCL for the electronic capture of clinical trial data. Over time, we are looking to make a wholesale move away from paper CRFs. Compliance with regulatory requirements is essential. Thus, we are looking for a hosted product, to meet the regulatory requirement that trial data are not in the sole control of the sponsor. A new eDC system will provide us validated tools for data management and monitoring, enhancing data quality and ensuring data integrity. We intend to integrate the new system with our existing inhouse systems for randomisation and drug supply. It is our intention that ongoing trials in our existing systems (in MACRO or in-house system) will complete in their current systems rather than be migrated into the new system. For long-term trials, we would look to redevelop in the new system rather than migrate.

A new eDC (electronic data capture) system is required by MRC CTU at UCL for the electronic capture of clinical trial data. Over time, we are looking to make a wholesale move away from paper CRFs. Compliance with regulatory requirements is essential. Thus, we are looking for a hosted product, to meet the regulatory requirement that trial data are not in the sole control of the sponsor. Our existing systems do not meet this requirement, as well as needing upgrading in terms of technology stack. A new eDC system will provide us validated tools for data management and monitoring, enhancing data quality and ensuring data integrity. We intend to integrate the new system with our existing inhouse systems for randomisation and drug supply. It is our intention that ongoing trials in our existing systems (in Macro or in-house system) will complete in their current systems rather than be migrated into the new system. For long-term trials, we would look to redevelop in the new system rather than migrate. The specification detailing UCL’s full requirements is set out in Schedule 5 (Specification) and should be read before bidders begin to respond to this ITT.