End-to-End Biometrics
Your entire biometrics pipeline, automated inside your environment.
Astraea's AI-native platform generates every biometrics deliverable — SAP, SDTM/ADaM, TLFs, Define-XML, and submission documents — running inside your validated environment. Our biostatisticians and programmers operate it end to end, so you get inspection-ready outputs through NDA, BLA, and IND without your data ever leaving your systems.
Platform-Powered Delivery
Premium biometrics deliverables, produced by the platform.
Every deliverable — SAP, SDTM/ADaM, TLFs, Define-XML, CSR support — is generated and QC'd by Astraea's controlled AI workflows. Our biostatisticians, programmers, and medical writers operate the platform inside your environment, under your SOPs, so outputs meet FDA and EMA expectations and are BIMO inspection-ready — without Astraea ever accessing your data. See how this model differs in Astraea compared with a traditional CRO.
What We Deliver
Deliverables across every study phase.
Trial Design & Planning
Protocol development, randomization schedules, sample size determination, and adaptive design support, with simulation built in.
Statistical Analysis Plans
Comprehensive SAP design and implementation aligned with clinical objectives, regulatory conventions, and downstream programming.
CDISC-Compliant Programming
SDTM and ADaM dataset generation, Define-XML, aCRF, and eCRT packages, validated end to end with Pinnacle 21.
Interim & Final Analyses
Support for DMC and DSMB activities, safety summaries, efficacy evaluations, and integrated summary packages.
Medical Writing
Integrated collaboration across biostatistics and scientific communications, CSRs, integrated summaries, and publication support.
Regulatory Submission Support
NDA, BLA, IND, and supplemental submissions to FDA and EMA, inspection-ready with full traceability.
Why Sponsors Choose Astraea
Regulatory precision, at platform speed.
Regulatory Precision
Deliverables meet FDA and EMA expectations and are BIMO inspection-ready, with independent QC on every dataset.
Unmatched Data Integrity
Automated validation, full traceability, and reviewer-ready documentation across SDTM and ADaM.
Platform-Powered Speed
Astraea's controlled AI workflows produce datasets and TLFs in a fraction of the time, so tight timelines no longer trade off against quality.
Your Data Never Leaves
The platform is deployed and operated inside your validated environment. Astraea never sees or holds your trial data.
Move from data to decision with confidence.
Tell us about your program and we'll scope a platform-led engagement — running in your environment — that fits your timeline, standards, and submission targets.