Newcastle Clinical Trials Unit (NCTU) is a UKCRC Registered CTU that works in collaboration with investigators to design and deliver clinical trials and studies answering important clinical questions, whose findings bring substantial impact to patients and the NHS; it has a portfolio across many clinical 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 £30m, these include international trials 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 ensures robust trial design are conducted in line with MHRA and other legislated regulatory requirements that stand up to international scrutiny. The systems(s) must be suitable for use in academic trials units and ensure they operate in a way which is complaint with applicable legislation. The systems should combine excellent functionality with customisability that will also require the set-up time of trials 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 Clinical Data Management System and Randomisation System to be used by all members of the 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 systems must be accessed via a web-based interface. The systems must have different user profiles to support the setting up, management and data removal for statistical analysis.
This tender process is divided two lots. Suppliers may submit a bid for one of the lots or both lots. Each Lot will be assessed separately. Lot 1 – Clinical Data Management System and Lot 2 – Randomisation System.

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