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Aperlena

Netherlands - Data services - Data Management Services

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Description

Provision of data management services for data review, validation, cleansing and maintenance; document redaction and assessment; and customer service. 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.; 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 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.

Official source

Source: TED - Tenders Electronic Daily (Publications Office of the EU)

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Last verified against TED - Tenders Electronic Daily (Publications Office of the EU) 3 weeks ago

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    • Title: "Netherlands - Data services - Data Management Services" to "Netherlands – Data services – Data Management Services"
    • Award date: Awarded on December 17, 2025
    • Scope and criteria: The description was expanded. Re-read it before you bid.

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Market context

Avg. open tender · IT services
€23,632,713
5,686 open across Europe right now 152% above sector average
Buyer track record on Aperlena
18 notices tracked · 7 awarded

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