Comparison
Astraea vs. Saama
Saama is an AI CRO — it runs biometrics and submission work for sponsors as a managed service on its own cloud platform. Astraea is software your team runs: forward-deployed engineers install it inside your own environment, where your data never leaves, and it automates everything after protocol and raw data — SAP, eCRFs, TFLs, SDTM and ADaM datasets, Define-XML, and QC.
What is Astraea?
Astraea is clinical trial automation software that pharmaceutical sponsors run themselves — not a CRO, and not a web-hosted service. It automates everything after protocol design and raw data collection: the SAP, eCRFs, TFLs, SDTM and ADaM datasets, Define-XML, QC, and the full set of FDA submission documents, in one auditable system. Because forward-deployed engineers install it inside the sponsor's own environment, Astraea never sees or holds your data. It is backed by Y Combinator (P26) and works across oncology, rare disease, other therapeutic areas, and medical devices.
The verdict
Saama is the right choice for teams that want a full-service AI CRO to run the biometrics and submission work for them, on a broad enterprise platform spanning clinical and commercial analytics. Astraea is the right choice for teams that want to run everything after protocol and raw data themselves — SAP, eCRFs, TFLs, datasets, Define-XML, and QC — deployed inside their own environment, where Astraea never sees their data. Astraea is software sponsors run to control their own trials — not a CRO that runs them for you.
Side by side
How Astraea compares to Saama.
Both use agentic AI to automate the pipeline. The difference is who runs it: software your team operates in your own environment versus a CRO that delivers the work for you on its cloud.
| Criterion | Astraea | Saama (AI CRO) |
|---|---|---|
| Delivery model | YesSoftware your team runs to create and control your own trials | PartialAI CRO — the work is delivered for you as a managed service |
| You run it in-house and stay in control | YesYour statisticians operate the pipeline and own every decision | NoA CRO team runs the biometrics and submission work on your behalf |
| Automates everything after protocol & raw data | YesSAP, eCRFs, TFLs, SDTM/ADaM, Define-XML, QC, documents — one system | YesBRAIN and Source-to-Submission automate across the pipeline too |
| Generates SDTM & ADaM datasets from raw data | YesDataset generation is core to the pipeline | YesAgentic AI generates datasets within the service |
| Agentic AI automation | YesAgentic execution across the full pipeline | YesSaama BRAIN is an agentic AI platform |
| Deployed in your environment (data never leaves) | YesInstalled in your systems by forward-deployed engineers; Astraea never sees your data | NoCloud platform; your data is processed in the vendor's cloud |
| Auditability & 21 CFR Part 11 | YesFull lineage, versioning, audit-ready by construction | YesValidated, GxP-aligned enterprise platform |
| Therapeutic & indication coverage | YesClients across oncology, rare disease, other indications, and devices | YesBroad, established across large pharma |
| Full-service CRO & commercial analytics breadth | NoFocused on the automation pipeline, not full CRO services | YesClinical + commercial analytics and full-service CRO delivery |
Where Saama wins
What Saama does best.
A full-service AI CRO
Saama runs the work for you. Teams that want a managed service — people and platform accountable for delivering the biometrics and submission work end to end — get an AI-augmented CRO rather than software they have to operate themselves.
Enterprise scale, proven with large pharma
Saama is an established enterprise vendor with a long track record across large pharmaceutical sponsors and big, complex programs. Organizations that need that scale and vendor maturity get it from Saama.
Breadth beyond biometrics
Saama's platform spans clinical and commercial analytics, not just the submission pipeline. Sponsors that want one vendor across trial analytics and commercial lifecycle data get a broader footprint than a focused pipeline tool.
Where Astraea wins
Software you run, in your environment.
01 · Software, not a CRO
You run it — nobody runs your trial for you.
This is the core difference. Saama is an AI CRO: its team delivers the work as a service. Astraea is software your own statisticians and programmers run to create and control your trials in-house. You keep ownership of the science, the pipeline, and the timeline — instead of handing them to an outside vendor.
02 · Deployed in your environment
Your data never leaves your systems.
Saama is a cloud platform, so your data is processed in the vendor's environment. Astraea is installed inside your own environment by forward-deployed engineers who work alongside your team, and Astraea never sees your data — a decisive difference for data residency, security, and IP.
03 · One focused pipeline
Everything after protocol and raw data, in one system.
Astraea generates the SAP, eCRFs, TFLs, SDTM and ADaM datasets, Define-XML, and QC end to end in one auditable system with named-reviewer sign-off on every output — a focused biometrics-to-submission pipeline rather than a broad enterprise suite delivered as a service.
FAQ
Astraea vs. Saama, answered.
The questions biometrics and biostatistics leads ask most when weighing software they run themselves against an AI CRO that delivers the work as a service.
Astraea vs. Saama — Common Questions
Is Saama a CRO?
What is the difference between Astraea and Saama?
Is Astraea better than Saama?
Can Astraea replace Saama?
Who should use Saama instead of Astraea?
See months of biometrics work compressed into days.
Astraea automates everything after protocol and raw data — SAP, eCRFs, TFLs, datasets, Define-XML, and QC — in one auditable system, deployed inside your environment where your data never leaves, with statisticians in control of every decision.