Database systems

Tender description

Newcastle University is looking to engage pre-tender with suppliers of Clinical Trials Data Management (CDMS) and a Randomization Systems. The purpose of the engagement is to understand the different solutions available and the pricing models. The information will be used to define the scope and specification of the Invitation to Tender. The University is looking for hosted solutions which are compliant with: — EU Clinical Trials Directive 2001/20/EC, — The Medicines for Human Use (Clinical Trials) Regulations 2004, and subsequent amendments, — Guideline for Good Clinical Practice E6(R2), — FDA 21 CFR Part 11, — Data Protection Act 2018, — Information Governance Toolkit, — access via secure SSL connections. Expressions of interest in this project can be made by registering via the University's e-tendering portal at: https://procontract.due-north.com/Login Newcastle University intends to purchase a Clinical Trials Data Management System (CDMS) and a Randomization System. Prior to advertising an Invitation to Tender (ITT) the University has issued a PIN for the purpose of engaging with the supply market to understand the different systems available. The information gained from the PIN will be used to inform the specification contained in the ITT. The CDMS will be used to support trials where data capture will be at multiple sites and for trials from Phase I to IV, scaling from single sites to multi-site trials. Access to and roles within the CDMS and Randomization System will be determined by University staff. The University wishes to meet with or hold a conference call with suppliers to: 1) View a demonstration of supplier systems and understand the functionality and analysis tools available; 2) Review systems compliance with the legislative requirements contained within: — EU Clinical Trials Directive 2001/20/EC, — the Medicines for Human Use (Clinical Trials) Regulations 2004, and subsequent amendments, — Guideline for Good Clinical Practice E6(R2), — FDA 21 CFR Part 11, — Data Protection Act 2018, — Information Governance Toolkit, — access via secure SSL connections; 3) Understand supplier pricing models and obtain indicative quotes for internal budgetary requirements. Expressions of interest in this project can be made by registering via the University's e-tendering portal at: https:// procontract.due-north.com/Login Further information is available to download from the above portal please see 2019 PIN Briefing Document EDMS and Randomisation_Final The dates for the meeting or conference calls are: 19th August (afternoon); 20th August (afternoon); 22nd August (afternoon); 22nd August (afternoon); 27th August (afternoon); 29th August (afternoon); 9th September; 16th September and 19th September (afternoon). The deadline for expressing an interest is noon 18.8.2019.