Compare Astraea
Astraea vs. Koneksa Lodestar
Koneksa Lodestar is an early-access, AI-assisted submission workflow that Koneksa evaluated using its completed LEARNS Parkinson's study. Astraea is sponsor-operated software installed inside your own environment, where Astraea never sees the data, automating the connected post-protocol-to-submission workflow.
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
Koneksa Lodestar is the right choice for teams prioritizing an early-access workflow that Koneksa says runs through eCTD assembly, BIMO packaging, and FDA/EMA staging, backed by Koneksa-reported metrics from its completed LEARNS study. Astraea is the right choice for teams that need everything after protocol and raw data automated inside their own environment — where data never leaves — generating the SAP, eCRFs, TFLs and shells, datasets, Define-XML, and QC, used in active client studies across oncology, rare disease, and devices. Astraea publicly commits to an in-environment deployment model; Koneksa's public Lodestar materials do not specify Lodestar's hosting options.
Side by side
Where Astraea wins, and where Koneksa does.
Both use AI to automate submission workflows. The documented differences include published workflow scope, availability, benchmark evidence, and the deployment commitments each vendor makes publicly.
| Criterion | Astraea | Koneksa Lodestar |
|---|---|---|
| Publicly documented deployment model | YesForward-deployed engineers install Astraea in your own systems; Astraea never sees your data | PartialKoneksa's public Lodestar materials do not specify whether Lodestar is vendor-hosted or available in a sponsor-controlled cloud |
| Availability model | YesDeployed with clients running active studies | PartialEarly access with select sponsor and CRO design partners; broader availability expanding through 2026 |
| Generates SAP, eCRFs & upstream artifacts | YesGenerates the SAP, eCRFs, and TFL shells — not just reads them | PartialLodestar begins with SAP interpretation and EDC ingest; Koneksa separately offers clinical database build and data-management services |
| Indication & complexity coverage | YesClients across oncology, rare disease, other indications, and devices | YesKoneksa says Lodestar is configured for eight therapeutic areas and was evaluated on its completed LEARNS Parkinson's study |
| Generates SDTM & ADaM datasets from raw data | YesDataset generation is core to the pipeline | YesSDTM mapping and ADaM generation in the workflow |
| Generates TFL / TLG shells and outputs | YesProduces the shells and the populated outputs in one flow | YesTLG shells and render step in the pipeline |
| Continuous QC & conformance validation | YesConformance QC runs across the pipeline, audit-ready by construction | YesConformance checks and double-programming QC run continuously |
| AI-assisted workflow automation | YesAgentic execution across the full post-protocol pipeline | YesKoneksa says Lodestar sequences ten connected, AI-assisted workflow steps |
| Human review & 21 CFR Part 11 workflows | YesHuman review, lineage, and versioning; designed for compliant 21 CFR Part 11 workflows | YesEach output approved by a named human, cryptographically signed under 21 CFR Part 11 |
| eCTD assembly, BIMO packages & EMA submission | PartialPublic Astraea scope centers on biometrics outputs and submission documents; eCTD/BIMO assembly is not currently listed | YesExtends through SDRG/ADRG, Define.xml, BIMO packages, eCTD Module 5.3, and EMA transmission |
| Vendor-published metrics from a completed study | PartialNo public single-study benchmark with comparable metrics | YesKoneksa reports 80% fewer programming hours, 65% lower biometrics cost, and 16x faster QC in its LEARNS comparison |
Deployment diligence
Your data never leaves your environment.
Astraea documents exactly where its software runs and who can access the data. Koneksa's public Lodestar materials do not specify Lodestar's hosting options, so buyers should confirm them directly.
Astraea · In your environment
Installed where your data already lives.
- Forward-deployed engineers install Astraea inside your own systems.
- Astraea never sees your subject-level data — it stays behind your walls.
- No trial data is uploaded to a vendor cloud to be processed.
- Human review, lineage, and versioning support compliant workflows on your infrastructure.
Koneksa Lodestar · Verify during evaluation
Public hosting model not specified.
- Koneksa's public Lodestar pages do not specify vendor-hosted versus sponsor-controlled deployment.
- Koneksa documents secure environments, encryption, role-based access, and audit trails across its platform.
- Its broader clinical platform can be Koneksa-hosted or deployed in a customer's cloud; Lodestar-specific options should be confirmed.
- Lodestar is currently offered through early access with select sponsor and CRO partners.
Where Koneksa wins
What Koneksa Lodestar does best.
The full submission-assembly tail
Lodestar extends past the datasets into SDRG/ADRG, Define.xml, BIMO inspection packages, eCTD Module 5.3, and staging for EMA and FDA transmission. Teams that want the regulatory-assembly steps automated in the same tool get that reach from Koneksa.
Vendor-published study metrics
Koneksa evaluated Lodestar using its completed LEARNS Parkinson's study and reports 80% fewer programming hours, 65% lower biometrics cost, and 16x faster QC versus its traditional comparison workflow. These are Koneksa-reported results from one study.
Published early-access evaluation path
Koneksa offers Lodestar through early access and design-partner engagement with select sponsors and CROs. Teams that value a structured pilot around its documented EDC-to-eCTD workflow may prefer that evaluation path.
Where Astraea wins
Broader upstream generation, with a defined deployment model.
Your data never leaves your environment.
Forward-deployed engineers install Astraea inside your own environment and work alongside your team, and Astraea never sees your data. Koneksa's public Lodestar materials do not state whether Lodestar can be deployed in a sponsor-controlled environment, so teams with strict data-residency requirements should verify that architecture directly during evaluation.
Running in active client studies.
Lodestar is in early access with select sponsor and CRO partners and was evaluated end to end on Koneksa's completed observational Parkinson's study. Astraea is deployed with clients running active studies across oncology, rare disease, other indications, and devices.
Creates the upstream, not just the datasets.
Koneksa publicly describes Lodestar as beginning with SAP interpretation and EDC ingest. Astraea generates the SAP, eCRFs, and TFL shells — then the SDTM and ADaM datasets, Define-XML, QC, and submission documents — in one auditable system with human review, lineage, and versioning.
FAQ
Astraea vs. Koneksa Lodestar, answered.
The questions clinical operations and biometrics leaders ask most when comparing intelligent submission tools.
Is Astraea better than Koneksa Lodestar?
Astraea is better for teams that require sponsor-operated automation deployed inside their own environment and broader upstream generation. Koneksa Lodestar is better for teams prioritizing its documented eCTD assembly, BIMO packaging, FDA/EMA staging, and published LEARNS benchmark. Koneksa's public Lodestar materials do not specify hosting options.
What is the difference between Astraea and Koneksa Lodestar?
Koneksa describes Lodestar as an early-access, AI-assisted workflow from EDC ingest through CDISC mapping, TLG generation, continuous QC, and eCTD assembly. Astraea is sponsor-operated software installed inside the sponsor's environment, where Astraea never sees the data, and it also generates upstream artifacts including SAPs and eCRFs.
Is Astraea cheaper than Koneksa Lodestar?
Koneksa's public Lodestar materials direct prospects to early-access and demo engagement rather than listing a price. Koneksa reports a 65% biometrics-cost reduction in its own LEARNS comparison. A reliable comparison requires proposals based on study volume, scope, services, and deployment model.
Can Astraea replace Koneksa Lodestar?
Astraea can replace or complement specific Lodestar workflows when a sponsor wants the post-protocol-to-submission pipeline deployed inside its own environment. Koneksa says Lodestar extends into BIMO packages, eCTD Module 5.3, and staging for FDA and EMA transmission. The products are not like-for-like across every workflow.
Who should use Koneksa Lodestar instead of Astraea?
Teams prioritizing Koneksa's documented EDC-to-eCTD workflow, biometric services, published LEARNS benchmark, and early-access engagement should consider Lodestar. Teams requiring sponsor-operated software inside their own environment, broader upstream generation, and a model where Astraea never sees the data should consider Astraea.
See if Astraea fits your submission pipeline.
Tell us about your studies and environment. 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 and statisticians stay in control.