Data Management Services

This is a call for tenders issued by the European Medicines Agency (EMA) for data management services, structured into three distinct lots. The overall estimated value for this procurement is €59,450,000, with the following allocations: Lot 1 for SPOR and Veterinary Medicinal Products Data Management at €36,000,000; Lot 2 for EudraVigilance and EurEKA services at €17,000,000; and Lot 3 for Anonymization and Redaction of documents at €6,450,000. The maximum contract duration for all lots is 72 months.

The procurement strategy is based on a framework agreement without reopening of competition, emphasizing a best price-quality ratio in the evaluation criteria. The submission process is mandatory to be conducted electronically, and the deadline for tender submissions is set for August 18, 2025.

Eligible applicants include any economic operators capable of fulfilling the specified requirements, with no explicit restrictions on the type of entities. This allows participation by corporations across the spectrum, including small and medium enterprises as well as larger companies. However, the SME suitability indicator is marked as false, indicating that larger entities may be better equipped to meet the tender's complex requirements.

The funding type is a procurement contract, not a grant, meaning successful bidders will receive monetary compensation for their services—further supported by electronic payment systems post-award. Geographic eligibility aligns with EU public procurement standards, generally allowing bidders from EU and EEA countries. However, international bidders must comply with EU data protection regulations, such as GDPR, in their service provisions.

The primary sector targeted by this call is the pharmaceutical and healthcare industry, reflected in the CPV classification of 72300000 for data services, specifically relating to medicinal product data management, pharmacovigilance data processing, and document confidentiality assessments.

The tender is categorized as an open procedure, meaning it is accessible to any qualified entity. Submission requirements include having a Personal Identification Code (PIC), which is a prerequisite for participation. The tender details are publicly published, and key documents are available for download, including the invitation letter and technical specifications.

In summary, this tender, expiring on August 18, 2025, seeks providers for specialized data management services integral to the EMA's regulatory operations, reinforcing the demand for quality-driven service provision in the pharmaceutical sector.

This is an invitation to tender for data management services issued by the European Medicines Agency (EMA). The procedure identifier is EMA/2024/OP/0019. The TED reference is 134/2025 464893-2025. The estimated total value of the tender is 59,450,000 EUR. The TED publication date is 16/07/2025. The deadline for receipt of tenders is 18/08/2025 at 16:00 Europe/Amsterdam. The date and time of public opening is 19/08/2025 10:00 Europe/Amsterdam. The contracting authority is not bound to reply to questions submitted after 08/08/2025 05:00 Europe/Amsterdam.

The tender is divided into three lots:

Lot 1: Data Management Services SPOR and Veterinary Medicinal Products Data Management. The estimated value for this lot is 36,000,000 EUR. The SPOR (Substances, Products, Organisations and Referentials) programme provides master data services (people, process, data and technology) for all SPOR data for both human and veterinary regulatory domains. The services are intended to support regulatory procedures throughout the European Union and across the whole medicinal product lifecycle. The SPOR programme enables master data to be re-used by EMA, National Competent Authorities (NCAs) and the industry across the different business processes. The maximum contract duration is 72 months. The award method is best price-quality ratio.

Lot 2: Data Management Services EudraVigilance and EurEKA. The estimated value for this lot is 17,000,000 EUR. EudraVigilance (EV) is the European data-processing network and management system, established at EMA to support the electronic exchange, management and scientific evaluation of Individual Case Safety Reports (ICSRs) related to all medicinal products authorized in the European Economic Area (EEA). EurEKA is the EMA's tool that encodes the undesirable effect terms from Summaries of (medicinal) Product Characteristics as MedDRA terms. The maximum contract duration is 72 months. The award method is best price-quality ratio.

Lot 3: Data Management Anonymization and redaction of documents and datasets. The estimated value for this lot is 6,450,000 EUR. The Agency assesses whether any information contained in some documents would constitute commercially confidential information (CCI) or protected personal data (PPD). The services covered by the procedure are intended to support the Agency in assessing the presence of CCI in the documents and to redact them, and in assessing the presence of PPD in the documents and to anonymize them. These services require scientific expertise in order to realize such CCI and PPD assessments. The maximum contract duration is 72 months. The award method is best price-quality ratio.

The main classification (CPV) for all lots is 72300000 Data services. The nature of the contract for all lots is services. The framework agreement is a framework agreement, without reopening of competition.

Submissions must be sent exclusively via electronic submission.

The following documents are available for download:

Invitation to tender letter (Invitation letter, All lots, Version 1, Published on 16/07/2025)
Annex XI.1 Statement of Work (Technical specifications, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.2 Profiles description (Technical specifications, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.3 Costing sheet and Price Scenario Lot1 (Financial offer form, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.4 Award Case Scenario for Technology Advancement and Response questionnaire (Technical specifications, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.5 Test package (Technical specifications, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.6 Draft framework contract Lot 1 (Draft contract, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.7 Draft Service Level Agreement (Draft contract annex, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.8 European Commission Standard Contractual Clauses between controller and processor (Draft contract annex, Lot 1, Version 1, Published on 16/07/2025)
Annex XI.9 Specific documents related to workstreams (Technical specifications, Lot 1, Version 1, Published on 16/07/2025)

FAQ regarding eSubmission:

How to proceed if the system is slow or doesn’t work while uploading/downloading documents? Use the latest versions of Google Chrome or Mozilla Firefox. If the issue persists, clear the cache and cookies on the Internet browser. Published on 13/02/2025 20:52
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Where can I find my submissions in Manage My Area, in the Funding & Tenders portal? In ‘My Submission(s)’: tenders in response to open calls for tenders, requests to participate. Published on 17/10/2024 20:40
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Can I view and edit my draft submission? Until the deadline for the submission has been reached, submissions in the draft status can be edited, viewed and deleted. Published on 24/03/2023 21:32
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I sent my submission on time and a few days later, I received an automatic email informing me that the deadline for the reception of submissions had been reached. Does this mean that my submission was not correctly sent? No, this is an auto-generated notification sent when the time limit of receipt defined for the call for tenders has been reached. Until then, you had the possibility of withdrawing. Published on 03/08/2021 22:05

In summary, this is a call for tenders by the European Medicines Agency for data management services. The tender is divided into three lots covering SPOR and veterinary medicinal products data management, EudraVigilance and EurEKA data management, and anonymization and redaction of documents and datasets. The total estimated value is 59,450,000 EUR, and the deadline for submissions is August 18, 2025. The tender documents and submission must be done electronically. A PIC code is mandatory for participation.

Eligible Applicant Types: The opportunity details do not explicitly list eligible applicant types. However, given that it is a call for tenders for data management services, it can be inferred that eligible applicants are likely to be companies, including SMEs and large enterprises, with expertise in data management, IT services, and potentially consulting firms. Research institutes or universities might be eligible if they have relevant service offerings.

Funding Type: Procurement. This is a call for tenders, indicating a procurement process where the European Medicines Agency (EMA) is seeking to purchase services.

Consortium Requirement: The opportunity details do not explicitly state whether a single applicant or a consortium is required. The FAQ mentions that a Personal Identification Code (PIC) is mandatory to participate in a call for tenders as a sole candidate/tenderer or as a member of a group (consortium). This suggests that both single applicants and consortia are eligible.

Beneficiary Scope (Geographic Eligibility): The opportunity is related to the European Medicines Agency (EMA) and mentions the European Economic Area (EEA) in the context of EudraVigilance. This suggests that the geographic eligibility likely includes the EU and EEA countries. However, the specific eligibility criteria should be checked in the official call documents.

Target Sector: This program targets the data services sector, specifically within the context of the pharmaceutical and veterinary medicine industries. It includes data review, validation, cleansing, maintenance, document redaction, anonymization, and customer service.

Mentioned Countries: No specific countries are mentioned, but the European Union (EU) and European Economic Area (EEA) are referenced.

Project Stage: The project stage is for service provision, indicating that the work involves the operational delivery of data management services rather than research, development, or demonstration.

Funding Amount: The estimated total value for the entire call for tenders is 59,450,000 EUR. The estimated values for the individual lots are: Lot 1 (Data Management Services-SPOR and Veterinary Medicinal Products Data Management): 36,000,000 EUR, Lot 2 (Data Management Services – EudraVigilance and EurEKA): 17,000,000 EUR, and Lot 3 (Data Management- Anonymization and redaction of documents and datasets): 6,450,000 EUR.

Application Type: Open call. The procedure type is explicitly stated as an "Open procedure."

Nature of Support: Non-monetary services. The selected tenderers will receive service contracts to provide data management services.

Application Stages: The number of stages is not explicitly mentioned, but it is a standard procurement process. Applicants will need to submit a tender, which will then be evaluated based on pre-defined criteria. This likely involves at least two stages: submission and evaluation.

Success Rates: The success rates are not provided in the opportunity details.

Co-funding Requirement: The opportunity details do not explicitly mention a co-funding requirement.

Summary:

This is a call for tenders by the European Medicines Agency (EMA) for the provision of data management services. The overall estimated value is 59,450,000 EUR. The call is divided into three lots: Data Management Services for SPOR and Veterinary Medicinal Products Data (36,000,000 EUR), Data Management Services for EudraVigilance and EurEKA (17,000,000 EUR), and Data Management for Anonymization and Redaction of Documents and Datasets (6,450,000 EUR). The services include data review, validation, cleansing, maintenance, document redaction and assessment, anonymization, and customer service. The procedure is an open call, and submissions must be electronic. The deadline for receipt of tenders is August 18, 2025. The contract duration is a maximum of 72 months. The award method is based on the best price-quality ratio. The call is relevant to companies with expertise in data management and IT services, particularly those with experience in the pharmaceutical and veterinary sectors. A Personal Identification Code (PIC) is required for participation, whether as a single applicant or as part of a consortium. The European Union and European Economic Area are likely the geographic areas from which applicants can apply.