Notice Information
Notice Title
Protas Unified Clinical Trials Management Platform
Notice 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.
Lot Information
Lot 1
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. Additional information: Price is not the only award criterion and all criteria are stated only in the procurement documents
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.
Renewal: 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.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-h6vhtk-0335c4
- Publication Source
- Find A Tender Service
- Latest Notice
- https://www.find-tender.service.gov.uk/Notice/000570-2023
- Current Stage
- Award
- All Stages
- Tender, Award
Procurement Classification
- Notice Type
- Tender Notice
- Procurement Type
- Standard
- Procurement Category
- Services
- Procurement Method
- Selective
- Procurement Method Details
- Competitive dialogue
- Tender Suitability
- Not specified
- Awardee Scale
- Large
Common Procurement Vocabulary (CPV)
- CPV Divisions
48 - Software package and information systems
72 - IT services: consulting, software development, Internet and support
-
- CPV Codes
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
72200000 - Software programming and consultancy services
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
Notice Value(s)
- Tender Value
- £30,000,000 £10M-£100M
- Lots Value
- £30,000,000 £10M-£100M
- Awards Value
- Not specified
- Contracts Value
- £29,310,190 £10M-£100M
Notice Dates
- Publication Date
- 9 Jan 20233 years ago
- Submission Deadline
- 10 Jun 2022Expired
- Future Notice Date
- Not specified
- Award Date
- 23 Dec 20223 years ago
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Cancelled
- Awards Status
- Active
- Contracts Status
- Active
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- QUALITY BY RANDOMIZATION LIMITED
- Contact Name
- Available with D3 Tenders Premium →
- Contact Email
- Available with D3 Tenders Premium →
- Contact Phone
- Available with D3 Tenders Premium →
Buyer Location
- Locality
- SALFORD
- Postcode
- M3 5GS
- Postcode Area
- Manchester
- Country
- England
-
- Major Region (ITL 1)
- TLD North West (England)
- Basic Region (ITL 2)
- TLD3 Greater Manchester
- Small Region (ITL 3)
- TLD34 Greater Manchester South West
- Delivery Location
- Not specified
-
- Local Authority
- Salford
- Electoral Ward
- Ordsall
- Westminster Constituency
- Salford
Further Information
Open Contracting Data Standard (OCDS)
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.