Published
Redéveloppement de la plateforme SIGREC (Système d'Information et de Gestion de la Recherche et des Essais Cliniques), maintenance et prestations associées
Notice number: 26-71360
KEY INFORMATION
- Submission deadline
- • Sep 14, 2026
- Location
- 🇫🇷 France
- Contracting authority
- CHU de Lille - ES du GHT HPGL
- Accepted Languages
- FRA
- Tender type
- Services
- Contract Value
- Published date
- Jul 19, 2026
TENDER DESCRIPTION
This tender seeks proposals for the comprehensive redevelopment, maintenance, and associated services of the SIGREC platform (Information and Management System for Research and Clinical Trials). Structured as a 60-month composite framework agreement, commencing approximately April 2027, the scope includes design, development, deployment, and ongoing maintenance, alongside functional enhancements, regulatory adaptations, consulting, and training. Key technical requirements mandate modern web development using widely adopted Open Source technologies, an API-first modular architecture, adherence to HL7 FHIR R4 and CDISC CTR-XML standards, robust application security (RGPD by design), federated authentication, and automated data recovery from sources like CTIS and ECLAIRE, with hosting on CHU de Lille infrastructure. Proponents must demonstrate structured project management, hold relevant certifications (e.g., ISO 27001 or equivalent), and provide financial declarations detailing global and contract-related turnover for the last three available financial years. Offers are required to be submitted in French and expressed in EURO, with the Service Ready Validation (VSR) expected around…
TENDER BRIEF
The contract timeline is as follows:
- Total Duration: 5 years from the date of notification (TO).
- Contract Start Date: Estimated April 2027, which is the notification date (TO).
- Key Milestones/Phases:
- Notification (TO): Marks the start of the contract, estimated for April 2027.
- Conception: Involves kick-off, detailed expression of needs, mock-ups, and MOA validation. The specific timeline for this phase is to be described by the candidate.
- Développement (Development): Includes the development of SIGREC API + XSD, interface, V1 inbound connectors, and migration. The specific timeline for this phase is to be described by the candidate.
- Recette et vérifications (Reception and Verification): Comprises internal reception, aptitude verification (VA), corrections, and initial training. The specific timeline for this phase is to be described by the candidate.
- VSR (Service Ready Validation): A contractual milestone that triggers maintenance, expected approximately 23 months after the notification date (T0 + 23 months).
The dates provided are provisional, and the detailed planning for the development phase will be proposed by the contractor in their offer.
Sources
- 1Note de Contexte du Projet SIGREC.pdf — “est établi sur une durée totale du marché de 5 ans à compter de la notification (TO). Les dates sont prévisionnelles; le planning détaillé de la phase de développement est proposé par le titulaire dans son offre. 5.2 GOU…”
- Modern web development (front-end and back-end) using widely adopted and well-documented Open Source technologies.
- REST API design.
- Interoperability principles.
- HL7 FHIR R4 as a reference for API structuring and for data recovery via API.
- CDISC CTR-XML as inspiration for XSD schema structure and nomenclature.
- Application security and RGPD compliance by design.
- Identity management and federated authentication using OAuth 2.0 / OpenID Connect.
- API-first, modular architecture, clearly separating front-end, back-end, and interoperability layer.
- Hosting on the CHU de Lille infrastructure.
- Automated data recovery from CTIS (EMA) via API REST/JSON.
- Automated data recovery from EUDAMED (EMA) via API EMA, with format to be specified.
- Automated data recovery from SI RIPH2G / ECLAIRE (ANS) via API FHIR R4.
- ClinicalTrials.gov consultation via AACT API and XML PRS file export.
- Exchanges with CTMS via SIGREC API or via import/export of XML files compliant with the SIGREC XSD schema.
- Conduction of a multi-year project with structured project management, including regular steering committees (quarterly COPIL, monthly COMOP) and iterative deliverables.
- Certifications required or equivalent: ISO 27001, ISO 9001, ISO 27701, ISO 20000-1, SOC 2 Type II report, or PGSSI-S.
- Offers must be written in French and expressed in EURO; if in another language, they must be accompanied by a French translation.
Sources
- 1Note de Contexte du Projet SIGREC.pdf — “solution développée et de l'ensemble de ses composants (code source, documentation, modules, contenus, nom de la plateforme, droits d'utilisation et interfaces s'y rapportant). Le titulaire réalisera la prestation de dév…”
- 2RC.pdf — “Signature Déclaration sur l'honneur pour justifier que le candidat n'entre dans aucun des cas | Oui d'interdiction de soumissionner | Renseignements concernant la capacité économique et financière de l'entreprise : Libel…”
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Unlock tender brief for freeTENDER DOCUMENTS
DIRECTORY • 6 FILES
- AWS-Achat_depot-sans-signature.pdf572 KBPDF
- RC.pdf99 KBPDF
- MPI1851594_AAPC.pdf14 KBPDF
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