Brief · Use case · Medical Affairs

Real-World Data Vendor Landscape.

LiveLandscape

Give the board a view of real-world data vendors: market size by source, who plays where by data type and what it means for evidence generation.

MarketVendors of claims, electronic health record and registry data

GeographyUnited States and Europe

ReaderAn evidence generation team

ExpertGlobal Real-World Evidence Lead

Not askedA ranking of vendors

LengthStandard

Real-World Data Vendor Landscape is a ready-made use case for Medical Affairs. It ships under the Landscape template.

For medical affairs and evidence leads. You get the picture in brief, the boundary and inclusion rule, size estimates side by side, vendors by data type and what it means for your studies. Figures are cited or marked as gaps.

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

The decision

What is the landscape of real-world data vendors that supply claims, electronic health record and registry data in the United States and Europe, for an evidence generation team?

What is mapped

For Europe there is a public catalogue of data sources, which makes the boundary checkable. The landscape uses it and says where the United States side has no equivalent.

Segment or source	What it holds	What the landscape does with it
The European catalogue of sources	The HMA-EMA catalogues are two public registries of metadata, one for real-world data sources and one for studies. They hold metadata only and give no access to the records.^{1European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.}	The catalogue entries, which describe data holder, countries, data type, time span and publications.
EMA’s own network	DARWIN EU is EMA’s network for generating real-world evidence, with a coordination centre and data partners that run analyses on their own data. Figures for data partners and countries change, so the landscape dates them.^{2European Medicines Agency. Data Analysis and Real World Interrogation Network (DARWIN EU).}	EMA’s DARWIN EU pages.
What regulators expect of the data	EMA’s reflection paper on real-world data in non-interventional studies, finalized in 2025, and the NICE framework, both of which ask whether data are fit for the question.^{3European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.,4National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). Published 23 June 2022.}	The reflection paper and the NICE real-world evidence framework.

What the landscape does

Metadata, not access. The HMA-EMA catalogues describe what data exist and how studies have used them, and they say that they do not provide access to the primary records. The landscape separates a source that exists from a source an evidence team can buy or license.^{1European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.}

Fit for purpose is the sponsor’s case to make. EMA’s reflection paper notes that it is for the applicant to justify that the use of real-world data is appropriate for regulatory decisions. The landscape lists, for each vendor, what a team would need to show about data quality.^{3European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}

The United States side. There is no public catalogue equivalent to the European one in the sources the landscape used. It lists US vendors from their own descriptions and marks each such entry as a company statement.

A framework for the questions payers ask. The NICE framework names three principles: data of good provenance, relevance and quality, transparent generation, and methods that minimize bias. The landscape uses them as the columns of its comparison of vendors.^{4National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). Published 23 June 2022.}

Recommended length

Standard

The market has a clear boundary and a short list of players. Standard carries the picture, the boundary, the numbers, the players and what it means in about 1,500 words.

You can pick another length on the form. The other two stay available.

Assumptions the landscape checks

The landscape states the assumptions its boundary and its sizes rest on, and says what each gap limits. Examples for this market:

A source listed in the catalogue is available to license on terms an evidence team can accept.
A vendor’s description of its coverage matches the data it supplies.
The reflection paper cited is the final version.

Standards, guidance and sources

European sources

HMA-EMA catalogues of real-world data sources and studies.^{1European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.}
EMA, Data Analysis and Real World Interrogation Network (DARWIN EU).^{2European Medicines Agency. Data Analysis and Real World Interrogation Network (DARWIN EU).}

Expectations of the data

EMA, reflection paper on use of real-world data in non-interventional studies to generate real-world evidence, final, 2025.^{3European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}
NICE real-world evidence framework, 2022.^{4National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). Published 23 June 2022.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any vendor known only from its own description, any source in a catalogue that is not for sale, and any US entry with no public record.

What arrives

The picture in brief
Scope and boundary
The market in numbers
Who plays where
What is shaping it
What it means for us
What we could not source

What it will not do

It does not rank players or give a single market size. It shows estimates side by side with their sources, and a position on a map is labeled analyst judgment.

It does not assess data quality for a particular study, and it does not recommend a vendor.

It does not give a single market size when the sources disagree. It shows each estimate and says why they differ.

It does not rank players. A map places them on defined axes and labels the placement as judgment.

It is a snapshot of one date, from public sources. A player it could not find is listed as a gap.

References

[1] European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies. Known from EMA’s news page and search excerpts; the catalogues themselves were not searched. The launch date is stated differently in EMA documents.
[2] European Medicines Agency. Data Analysis and Real World Interrogation Network (DARWIN EU). Known from EMA’s page listing and search excerpts; partner and study counts change.
[3] European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025. Status and dates as given in EMA’s page listing and search excerpts; the paper was not read in full.
[4] National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). Published 23 June 2022. Known from NICE’s page listing and search excerpts; the framework was not read in full.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

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