Comparison
Astraea vs. Traditional CRO & In-House Biometrics
A traditional CRO or in-house team brings deep therapeutic expertise and accountability regulators trust. Astraea automates the mechanical 80% of the biometrics pipeline around that expertise — so submission-ready outputs arrive in days, not months.
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
A traditional CRO or in-house biometrics team is the right choice when you need deep therapeutic judgment, established regulatory relationships, and a single accountable partner. Astraea is the right choice for teams that want the entire biometrics pipeline — SDTM, ADaM, TFLs, Define-XML, and Pinnacle 21-style QC — automated end to end in one auditable system that runs inside your own environment, where Astraea never sees your data, compressing months of manual programming into days while statisticians keep control of every scientific decision. Astraea is software your team runs to take control — not a CRO that runs the trial for you.
Side by side
How Astraea compares to a CRO or in-house team.
Overseeing a CRO and running biometrics in-house are different operating models — both carry high cost and long timelines. Astraea removes the manual labor from either path without removing the expertise.
| Criterion | Astraea | Traditional CRO | In-House Biometrics |
|---|---|---|---|
| End-to-end pipeline in one system | YesSAP, eCRFs, TFLs, SDTM/ADaM, Define-XML, QC, documents — one auditable system | PartialStitched across vendor teams, tools, and handoffs | PartialStitched across internal functions and point tools |
| Time to submission-ready outputs | YesDays | NoMonths (industry avg ~68-day build, ~35-day lock) | NoMonths, gated by internal team capacity |
| Automation model | YesAgentic execution, human-reviewed | NoManual SAS/R programming by vendor FTEs | NoManual SAS/R programming by internal staff |
| Human-in-the-loop control | YesNamed-reviewer sign-off on every output | YesCRO statisticians own the analysis | YesYour statisticians own it directly |
| Auditability & traceability | YesFull lineage, versioning, 21 CFR Part 11 aligned | YesStandard practice (double programming) | YesDepends on internal SOPs and double programming |
| CDISC / regulatory conformance | YesSDTM, ADaM, Define-XML, Pinnacle 21-style checks built in | YesEstablished conformance workflows | PartialRelies on in-house CDISC expertise |
| Therapeutic & indication coverage | YesClients across oncology, rare disease, other indications, and devices | YesDeep, cross-indication, established | PartialLimited to your team's own indications |
| Cost model | YesPlatform subscription | NoPer-study fees / vendor FTE billing | NoFull-time headcount, tooling, and overhead |
| Data ownership & control | YesRuns in your environment; Astraea never sees your data | PartialFragmented across vendor handoffs | YesData stays inside your own environment |
| Deployment / ramp | YesInstalled in your environment by forward-deployed engineers | NoVendor onboarding and contracting | NoHiring and ramping a specialized team |
Where a CRO wins
What a traditional CRO or in-house team does best.
Deep therapeutic expertise
Established CROs bring cross-indication statistical judgment and years of study-design experience that Astraea does not replace.
Regulatory relationships & accountability
A CRO is a single accountable partner with existing FDA/EMA/PMDA relationships and defense experience through inspection.
Full-service trial operations
A CRO can run the whole trial operationally — site management, monitoring, and clinical operations — as an outsourced service. Astraea is software your team runs to create and control your own trials, not a services team that runs them for you.
Where Astraea wins
Three reasons teams automate the pipeline with Astraea.
01 · Whole pipeline
One system, not stitched tools and teams.
Astraea automates everything after protocol and raw data — the SAP, eCRFs, TFLs, SDTM and ADaM datasets, Define-XML, QC, and submission documents — in one auditable system, instead of stitching outputs across separate teams and point tools.
02 · Months to days
Compressed timelines, without losing control.
Agentic execution compresses the mechanical ~80% of biometrics work — derivations, mapping, QC — that takes months of manual programming today, while statisticians keep scientific judgment and named-reviewer sign-off on every output.
03 · Built for regulators
Inspection-ready by construction.
CDISC-native with Pinnacle 21-style checks built in, full lineage and versioning, and 21 CFR Part 11-aligned audit trails — inspection-ready by construction, not reverse-engineered at study end.
FAQ
Astraea vs. CRO, answered.
The questions biometrics and biostatistics leads ask most when weighing automation against a traditional CRO or in-house team.
Astraea vs. Traditional CRO — Common Questions
Is Astraea better than a traditional CRO?
What is the difference between Astraea and a CRO?
Is Astraea cheaper than a CRO?
Can Astraea replace my CRO or in-house team?
Who should use a traditional CRO instead of Astraea?
See months of biometrics work compressed into days.
Keep your statisticians in control of the science. Let Astraea automate the pipeline around them — CDISC-native, auditable, and inspection-ready by construction.