Brief · Use case · Clinical Operations
Decentralized Trial Vendor Landscape.
LiveLandscapeGive the board a view of CROs offering decentralized and hybrid trial services: size by source, who plays where and what it means for partner choice.
Decentralized Trial Vendor Landscape is a ready-made use case for Clinical Operations. It ships under the Landscape template.
For clinical operations leads selecting partners. You get the picture in brief, the boundary and inclusion rule, size estimates side by side, vendors by segment and what it means for the program. Figures are cited or marked as gaps.
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The decision
What is the landscape of contract research organizations offering decentralized and hybrid trial services, for a sponsor choosing partners for a Phase 3 program?
What is mapped
The inclusion rule is the heart of this landscape. A vendor is included only if it offers decentralized elements as the regulators define them, and the landscape says how it checked.
| Segment or source | What it holds | What the landscape does with it |
|---|---|---|
| The regulators’ definition | FDA’s guidance describes a decentralized trial as one that includes decentralized elements, where trial activities occur at locations other than traditional sites, such as telehealth visits and in-home visits.1 | FDA’s final guidance of September 2024. |
| The European view | The European medicines regulatory network’s recommendation paper of December 2022, with an annex of national provisions that changes over time.2 | EMA’s ACT EU recommendation paper. |
| The standard they must meet | Annex 2 of ICH E6(R3), adopted on 3 June 2026, covers decentralised elements, pragmatic elements and real-world data.3 | The ICH good clinical practice guideline. |
What the landscape does
An inclusion rule a sponsor can check. The landscape states what a vendor must offer to be included, for example remote data capture or home visits, and where it found the evidence, such as a vendor’s published service descriptions. Vendors that do not meet the rule are counted and set aside.1
Acceptance differs by region. The European recommendation paper is a recommendation from the regulatory network with a national annex, and national provisions vary. The landscape records which vendors operate in the countries a Phase 3 program would use.2
Market size from filings, side by side. Commercial size estimates for contract research differ by definition. The landscape cites listed companies’ filings and the reports it found, with their definitions, and does not average them.
What a sponsor will ask next. A sponsor choosing partners needs to know what a vendor could do under the current standard. The landscape notes where the new ICH annex changes what is expected.3
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:
- Vendors’ published descriptions reflect what they deliver in a Phase 3 trial.
- The countries the sponsor will use accept the decentralized elements the vendors offer.
- The ICH annex is in effect in the regions the sponsor will use.
Standards, guidance and sources
Regulators and standards
The decision practice behind the memo itself is on the template page.
What gets flagged
Any vendor included on its own description alone, any country whose provisions the landscape could not confirm, and any size estimate with a different definition from the others.
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 is not a vendor selection and does not assess any vendor’s quality.
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] U.S. Food and Drug Administration. Conducting Clinical Trials With Decentralized Elements. Final guidance, September 2024. Docket FDA-2022-D-2870. Status and definition as given in FDA’s announcement and search excerpts; the guidance text was not read in full.
- [2] European Medicines Agency and the European medicines regulatory network (ACT EU). Recommendation paper on the use of decentralised elements in clinical trials. First published December 2022. Known from EMA’s news page and search excerpts. Check whether a newer version exists.
- [3] International Council for Harmonisation. ICH E6(R3): Guideline for good clinical practice. Principles and Annex 1 adopted 6 January 2025; Annex 2 adopted 3 June 2026. Dates as given in ICH and EMA listings found by search; EU effective dates are stated differently on EMA pages, so check the current page.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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