Protas Unified Clinical Trials Management Platform

Concepts

• protas
• salford
• software programming
• trial design
• clinical trials
• support of the platform
• run trials
• complexity of the current clinical trial process
• non-functional requirements of the future platform
• clinical trials management platform

Location

SALFORD

Description

Protas, a non-profit organisation, will facilitate the development of better treatments for common diseases and improve public health outcomes by combining smart randomized trial design with effective technology and collaborative partnerships with organisations undertaking clinical trials. Protas seeks to engage a provider to design, develop, deploy, operate, and support a new, globally available, Unified Clinical Trials Management Platform (UCTMP). A more detailed description of the procurement is provided below. The full scope of the services required is provided in the tender documentation.

Total Quantity or Scope

Protas, a not-for-profit organisation, was formed in 2020 to transform the way clinical trials are run and to reduce the barriers to the discovery and licensing of new medicines. Large-scale randomized trials are powerful approaches to demonstrating the safety and efficacy of new medicines; the current Recovery trial used national datasets and large populations properly randomized to demonstrate the efficacy of dexamethasone in treating Covid in the most ill people as well as unequivocally demonstrating the lack of effect of hydroxyquinoline in the same patient group. There is an opportunity for well-designed large-scale trials with randomization and clear outcomes to transform the cost of drug development. The excessive cost and complexity of the current clinical trial process has made development of new medicines (especially for common chronic conditions) a high-risk business. Phase 3 trials for drugs are very expensive (typically costing hundreds of millions of US Dollars and potentially over 1billion US Dollars). As a consequence of the very high cost, too few participants may be recruited, or the trial may be run for too short a period to demonstrate the full effect of the treatment. As a result, many pharmaceutical companies are re-directing their portfolios to treatments for rare diseases, the resultant lack of new treatments for common, chronic conditions will place a significant burden on healthcare systems and funders. Well-designed trials, efficiently run can be completed typically a fraction of the average cost of a trial. To achieve this requires: • Good design with focus on a few principal outcomes supported by follow up through health records; • Efficient processes for running trials in as few locations as possible; and • A unified IT system that supports data ingress, use and analysis, enables the entire process of running and monitoring the trial and complies with the regulatory and data use requirements of different national bodies. Protas has the expertise and processes to deliver well-designed, efficiently run trials and now seeks to engage a provider to design, develop, deploy, operate, and support a new, globally available, highly configurable, first in class Unified Clinical Trials Management Platform (UCTMP). The functional and non-functional requirements of the future platform are articulated in the tender documentation. Once on contract, and through an Agile software development process, the chosen supplier will be required to define the individual implementation level requirements in collaboration with the Protas Product Team. Collaboration with the Protas Product Team will be further required during consecutive Agile sprints as platform functionality is iteratively designed, developed, and deployed in readiness for configuration for the first clinical trial. Continual verification and validation to regulatory standards will be required. As such, the contract covers development and concurrent operation and support of the platform as functionality is taken into use. The future Protas UCTMP will be required to support all phases during the lifecycle of a typical clinical trial: Phase 1 - Trial design. Phase 2 - Prepare for delivery. Phase 3 - Recruit to trial. Phase 4 - Follow up. Phase 5 - Close and analyse. Phase 6 - Post-trial activities. These phases are typical and provided as an illustration only. Clinical trial context is described in more detail in the draft Invitation to Participate in Dialogue (ITPD). Protas' main business will be running trials for customers, but it may elect to license the UCTMP to customers to use in trials they conduct themselves (or with another third party) and Protas may be involved in training such customers (and/or another third party) in the use of UCTMP. As such, Protas expects to have the commercial freedom to license use of the UCTMP to other parties. The precise requirements that a customer of Protas may need will depend on the logistics of running a particular trial and the provider may therefore be required to provide services to Protas which are in support of a service which Protas provides to a customer (although such support and the terms of such support would be equivalent and no more onerous to those involved in a trial which Protas might run itself). The UCTMP requirement is described functionally by 22 feature groups each with listed features and supporting detail. Additionally, a list of non-functional requirements describes the overarching properties required. The full set of requirements are set out in the Statement of Work (SoW) provided as part of the tender documents.

Renewal Options

The contract will be for an initial duration of 36 months. Protas will have two options to extend the contract, each option for a period of 24 months, providing a maximum contract duration of 7 years. The contract will be for an initial duration of 36 months. Protas will have two options to extend the contract, each option for a period of 24 months, providing a maximum contract duration of 7 years.

CPV Codes

• 72200000 - Software programming and consultancy services
• 48180000 - Medical software package
• 48430000 - Inventory management software package
• 48460000 - Analytical, scientific, mathematical or forecasting software package
• 48600000 - Database and operating software package
• 48814200 - Patient-administration system
• 48814400 - Clinical information system
• 72210000 - Programming services of packaged software products
• 72220000 - Systems and technical consultancy services
• 72250000 - System and support services
• 72261000 - Software support services
• 72262000 - Software development services
• 72263000 - Software implementation services
• 72265000 - Software configuration services
• 72266000 - Software consultancy services
• 72267000 - Software maintenance and repair services
• 72316000 - Data analysis services
• 72317000 - Data storage services
• 72322000 - Data management services

Indicators

• Bids should cover the whole contract.
• Options are available.
• Renewals are available.
• Award on basis of price and quality.

Other Information

A detailed timetable is provided in the procurement documents. A high-level summary is as follows: 11:00am (GMT) on 10th June 2022: Deadline for submission of supplier responses to Selection Questionnaire 1st July 2022: Estimated date of despatch of Invitations to Participate in Dialogue (ITPD) 11th July-26th August: 7-week dialogue period (expected dates) 9th September: Estimated date of despatch of Invitations to Submit Final Tender (ISFT) 16th November: Estimated date of Contract Award All interested suppliers are required to register into the Protas Platform Procurement Data Room where they can access the Selection Questionnaire (SQ) and all procurement documents. Access is provided for free and there is no barrier to entry. Suppliers wishing to raise clarification questions are welcome to do so via the data room by using the communications functionality therein. The data room can be accessed via this URL address: https://award.bravosolution.co.uk/protas/web/project/4cd04141-cd84-4dd6-84ba-863... Groups of economic operators may participate in this contract opportunity and are not required to have a specific legal form in order to submit a tender or a request to participate. However, Protas requires that any contract awarded by Protas pursuant to this procurement process will be entered into with a single contracting party. This Contract Notice is linked to the Prior Information Notice (PIN) titled 'Protas Clinical Trials Management Platform' published 2 December 2021 via the www.gov.uk/find-tender service. The direct link to the PIN is here Protas Clinical Trials Management Platform - Contracts Finder. The procurement documentation relating to this contract notice fully replaces the previously published Request for Information (RFI), which is now out of date. The Protas website provides additional information related to this procurement. Recent press releases may be particularly relevant. See - Protas | News & Stories. All communication regarding this procurement must be conducted via the Protas Platform Procurement Data Room. Suppliers corresponding with Protas about this procurement via email will be referred to the Protas Platform Procurement Data Room. In order to submit a request to participate in this procurement, a supplier must complete the Selection Questionnaire (SQ) and upload it to the Protas Platform Procurement Data Room no later than 11.00am (GMT) on 10th June 2022. Suppliers who expect to submit an SQ response are invited to indicate their intention to submit in advance of the deadline to Protas via the data room. This will be interpreted as the supplier's expression of interest. Suppliers that do not express an interest are still fully entitled to submit an SQ response before the deadline. Protas reserves the right to change without notice the procedure for awarding the contract, to reject all or any bids for the contract; to terminate discussions with any or all interested parties and/or to stop the process and not award a contract at any time without liability on its part. Protas also reserves the right to award a contract for only part of the advertised scope. Protas shall not be liable for any costs or expenses incurred by any supplier in connection with the completion and return of the information requested in this contract notice, or in the completion or submission of any tender.