DARWIN EU® Coordination Centre 2

Selection criteria: legal and regulatory capacity – 13.1 Requirement: The interested economic operator must have the legal and regulatory capacity to pursue the professional activity needed for performing the contract.

Selection criteria: financial and economic capacity – 14.1 Requirement: Interested economic operators must be financially feasible and in a stable financial position and have the economic and financial capacity to perform the contract. The annual turnover of the interested economic operators or, in the case of non-profit organisations, their income and endowments, must be of a minimum value of EUR 26,000,000 for each of the last two financial years. In order to be financially feasible, an entity must be able to demonstrate a favourable total score for the following: liquidity, capability to cover its short-term commitments; solvency, capability to cover its medium and long-term commitments; and profitability, generating profits, or at least with self-financing capacity.

Selection criteria: technical and professional capacity – Requirement & evidence: conflict of interest and/or professional conflicting interest: The economic operator (including all partners in case of joint tenders) and subcontractors and the proposed personnel shall not have any conflicting interest (that is, 'conflict of interest' and 'professional conflicting interest') within the meaning of Article II.1 of the draft framework contract (Annex VII), which could affect the performance of the services of the contract. It follows that the interested economic operator (including all partners in case of joint tenders) and subcontractors shall not be in any situation that could compromise the impartial and objective performance of the contract with regard to the rendition of the services and/or supplies. In its assessment, EMA will take into consideration if an interested economic operator and/or subcontractor: is a pharmaceutical company as defined in Article 3.2.1 of the European Medicines Agency policy on the handling of competing interests of scientific committee's members and experts (EMA/54457/2024 of 12 December 2024); is a company in the biotechnology sector as defined in Article 3.2.1 of the above-mentioned policy; is a unit of a research organisation that manufactures medicinal products (including ATMPs under the hospital exemption) or acts as a marketing authorisation applicant or holder of a medicinal product.

Selection criteria: technical and professional capacity – Criterion 1: Federated network coordination experience: Documented experience of coordinating a network of real-world data partners for conducting multi-database non-interventional studies in a federated database network environment: for at least 3 years since 1 Jan 2020; and consisting of at least 3 data sources; and in at least 2 different European countries.

Selection criteria: technical and professional capacity – Criterion 2: Multi-database non-interventional study experience: Documented experience of at least 3 years since 1 Jan 2020 of conducting all the following steps of multi-database non-interventional studies: 1) feasibility assessment, 2) development of study protocol, 3) data analysis, and publication of study report.

Selection criteria: technical and professional capacity – Criterion 3: Human resources capacity: Documented evidence of available necessary capacity (quantity and seniority) of human resources for the expected volume of contract outputs (e.g. number of non-interventional studies) throughout the entire duration of the contract.

Selection criteria: technical and professional capacity – Criterion 4: OMOP Common Data Model experience: Documented experience of: converting healthcare data set into the OMOP common data model, AND; performing or coordinating federated analysis using the OMOP common data model.

Selection criteria: technical and professional capacity – Criterion 5: Data quality management experience: Documented experience of performing data quality management steps in healthcare data aligned to principles of data quality frameworks (e.g. EMA DQF) to verify the reliability of data sources for their use in non-interventional studies.

Selection criteria: technical and professional capacity – Criterion 6: Volume of multi-database non-interventional studies: Documented experience of having designed and conducted at least 20 multi-database non-interventional studies since 1 Jan 2020.

Selection criteria: technical and professional capacity – Criterion 7: IT, security and data protection: Knowledge and experience of identifying, handling, assessing and mitigating IT and Security risks related to cloud security and personal data protection.

Environmental, social and labour law compliance: Compliance with applicable environmental, social and labour law obligations established by Union law, national legislation, collective agreements or the international environmental, social and labour conventions listed in Annex X to Directive 2014/24/EU.

English language proficiency: The working language of the Agency is English and the contractor must confirm that it will be able to communicate with the Agency in English for seamless implementation and execution of all the services covered within the scope of the contract, including at the level of English proficiency and quality of scientific writing and the responsibilities resulting from regulatory requirements such as Health and Safety and Data Protection, as well as for the efficient and timely response in respect to contract management.

EU data protection compliance: Processing of personal data in connection with this service must comply with EU data protection legislation, in particular, Regulation (EU) 2016/679 (General Data Protection Regulation), in such a manner that processing of personal data will meet the requirements of Regulation (EU) 2018/1725.

Access to network of specialists: The economic operator must have access to a network of specialists required to perform the services to be delivered by the Coordination Centre and oversee all aspects of the operations of the Coordination Centre and the data partners.

Key personnel availability: Key personnel shall be made available in sufficient quantity and seniority. Notably, a minimum of one senior person (with at least seven years of experience) in each of the following expertise areas shall be available during the contract implementation: computer science, data management, data analysis, pharmacoepidemiology, statistics, personal data protection, project management and scientific reporting/medical writing. Study-specific clinical expertise shall be accessible, as needed. The expertise needs to be at sufficient volume and seniority levels to allow high quality of deliverables at scale, with a clearly defined time commitment to DARWIN EU®.

Confidentiality, integrity and availability: The economic operator must ensure the principles of confidentiality, integrity and availability during the provision of services are respected.

Disaster Recovery and Business Continuity Plan: The economic operator must adhere to the currently available Disaster Recovery and Business Continuity Plan (Annex XIII of the draft Framework contract (Annex VII)) and keep it current with updates and tests as per EMA requests.

Service Level Agreement (SLA): The economic operator must commit and adhere to the Service Level Agreement (SLA) available in Annex XII of the draft Framework Contract (Annex VII). The Agency may review the SLA from time to time and request amendment at its discretion.