NU/1960 Supply and Installation of a Randomisation System

Newcastle Clinical Trials Unit (NCTU) is a UKCRC Registered CTU that works in collaboration with investigators to design and deliver trials and studies answering important questions, whose findings bring substantial impact; it has a portfolio across many health and care disciplines and from different funders (public, commercial, and charitable). There are currently over 40 active interventional trials with a total funding value is excess of £50m, these include international trials and studies and a growing portfolio of trials with adaptive designs. Most of the portfolio are regulated by the Medicines for Healthcare Products Regulatory Agency (MHRA).

NCTU works in a demanding and constantly evolving ethical, legal, regulatory and scientific landscape, across multiple countries. We seek opportunities for faster, more efficient, cost effective, and better research. NCTU requires systems that ensure robust trial and study design are conducted in line with MHRA and other legislated regulatory requirements that stand up to international scrutiny. Systems must be suitable for use in academic trials unit and ensure they operate in a way which is complaint with applicable legislation and should combine excellent functionality with customisability that will also require the set-up time of trials and studies to be minimised without impacting on staff time needed to develop, test, and deploy trials and studies within the system. Staff move between locations to work, including from NHS Trusts and from home, and thus secure access from any location is needed to both build and manage the systems.

The scope is for the supply, implementation and support for a randomisation system to be used for clinical trials by all members of NCTU, and by trial teams across multiple clinical sites, nationally and globally. The requirements are for established cloud-based, off the shelf solutions which are in use within clinical trial environments. The system must be accessed via a web-based interface. The system must have different user profiles to support the setting up, management and data extraction for statistical analysis. These should include the user types detailed in Sections 2.5.1.6.

Newcastle University is not classified as a contracting authority and as such is not obliged to comply with Public Contracts Regulations 2015 (PCR), although we may choose to do so if required by a public funding body. For the avoidance of doubt, this opportunity is not being tendered as a regulated procedure under PCR but will follow an equivalent procedure deemed by the University to be fair and transparent. This ITT is issued as a competitive procurement procedure, publicly advertised on the University's e-tender system ProContract.