Astraea GTM brain
Astraea provides sponsor-operated AI software for clinical data management and statistical programming through submission preparation.
category
Clinical biometrics automationmarket profile
- text: Clinical biometrics involves dependent standards, analysis datasets and outputs that require expert review and traceability.
- text: Sponsors can compare internal programmers, CRO services and emerging biometrics automation platforms.
personas
- title: Head of biometrics or statistical programmingpains:
- SDTM, ADaM and TFL production consumes scarce programming capacity
- Study revisions propagate across outputs and require repeated QC
- title: Clinical data management directorpains:
- Protocol rules and edit checks require manual translation
- Disconnected data and documentation handoffs complicate review
- title: Clinical quality or information security leaderpains:
- Must establish validation, access and accountability before clinical data enters a workflow
- Needs traceability from source data to approved output
icp
- text: Biotech and pharmaceutical sponsors running complex Phase II or III studies, particularly oncology and rare disease.
- text: Sponsor teams with qualified biometrics reviewers, existing clinical systems and an environment capable of hosting the software.
message pillars
- text: Accelerate standard study deliverables, subject to review and validation.
- text: Keep clinical experts accountable for final outputs.
- text: Maintain continuity between artifacts and review.
objections
- objection: Can AI outputs meet our regulatory and quality standards?response: Pilot one study deliverable with independent QC, traceability and documented sponsor validation before broad use.
- objection: We already use a CRO or statistical programming team.response: Evaluate a focused workflow alongside existing providers while preserving sponsor and expert responsibilities.
- objection: Clinical data cannot leave our controlled environment.response: Evaluate the customer-environment deployment and agree access and security controls with IT and quality.
competitors
- name: Clymb Clinicalwebsite: https://www.clymbclinical.com/why: Clymbr Hub automates SDTM, ADaM and TFL workflows with biometrics services.
- name: Emmes Group Veridix AIwhy: Its biostatistics agent addresses clinical data transformations and TFL generation.
- name: Saamawhy: Provides clinical data management, biostatistics and AI-enabled analytics.
influencers
- name: Sanmay Saradaurl: https://www.linkedin.com/posts/sanmay-sarada_launched-and-in-production-if-youre-a-clinical-activity-7460818058811662337-QcD_why: Cofounder sharing the launch with clinical sponsors and CROs.
- name: Joshua Wangurl: https://www.linkedin.com/posts/joshua-wang-229196319_excited-to-be-in-the-space-activity-7460813784299819008-nSNewhy: Cofounder and CEO sharing the company launch.
keywords
- clinical biometrics automation
- SDTM mapping automation
- ADaM programming AI
- TFL generation clinical trials
- clinical statistical programming software
- CDISC submission automation
- clinical data QC
voice
- precise and clinical
- accountability-conscious
- practical
signals
- text: A sponsor is preparing a Phase II or III readout or regulatory submission and needs more biometrics capacity.
- text: Hiring SDTM or ADaM programmers or changing CRO arrangements suggests an active capacity or workflow decision.
stack
- R
- SAS
- CDISC SDTM
- ADaM
pricing
model: unknown
motion
sales_ledchannels
- industry events
- SEO
confidence
highFounders
- name: Joshua Wangtitle: Founder/CEOrole: CEObio: Stanford dropout previously studying CS and Math. Top 250 united states (USAMO) Qualifier, USACO Platinum, first intern at Salient (W23) developing enterprise systems.
- name: Sanmay Saradatitle: Founder/CTOrole: CTObio: prev Data Engineer @ Baylor College of Medicine | 4 Publications in Fetal Medicine | CS and Bio at Stanford