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End-to-End Biometrics

Full-service biostatistics, from protocol to submission.

Astraea pairs cross-functional biostatistics and programming teams with our AI-native platform to deliver inspection-ready outputs, from protocol design through NDA, BLA, and IND submissions.

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Next-Level Biostatistics

Experts with a standards-native platform underneath them.

Our biostatisticians, programmers, and medical writers deliver everything you expect from a premium biometrics provider, protocol, SAP, SDTM/ADaM, TLFs, CSR support, accelerated by Astraea's controlled AI workflows. Every deliverable meets FDA and EMA expectations and is BIMO inspection-ready.

What We Deliver

Deliverables across every study phase.

  1. 01

    Trial Design & Planning

    Protocol development, randomization schedules, sample size determination, and adaptive design support, with simulation built in.

  2. 02

    Statistical Analysis Plans

    Comprehensive SAP design and implementation aligned with clinical objectives, regulatory conventions, and downstream programming.

  3. 03

    CDISC-Compliant Programming

    SDTM and ADaM dataset generation, Define-XML, aCRF, and eCRT packages, validated end to end with Pinnacle 21.

  4. 04

    Interim & Final Analyses

    Support for DMC and DSMB activities, safety summaries, efficacy evaluations, and integrated summary packages.

  5. 05

    Medical Writing

    Integrated collaboration across biostatistics and scientific communications, CSRs, integrated summaries, and publication support.

  6. 06

    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 AI-native speed.

Regulatory Precision

Deliverables meet FDA and EMA expectations and are BIMO inspection-ready. Independent QC on every dataset.

Unmatched Data Integrity

Pinnacle 21 validation, full traceability, and reviewer-ready documentation across SDTM and ADaM.

Collaborative Delivery

Seamless coordination among statisticians, programmers, and medical writers, backed by one shared platform.

Proven Track Record

Trusted by leading sponsors to ensure compliant, high-quality submissions under tight timelines.

Move from data to decision with confidence.

Tell us about your program, we'll scope a project-based engagement that fits your timeline, standards, and submission targets.

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