About Pharmastructure

We design and implement unified, compliant data platforms for pharmaceutical and biotech organizations. Our architecture‑first, vendor‑neutral approach consolidates EDC, CTMS, PV/Safety, Regulatory, Labs, and Manufacturing into a governed, analysis‑ready foundation—delivered in your tenant so you retain control.

Mission

Help life sciences accelerate R&D, enhance compliance, and prepare for an AI‑enabled future by delivering scalable, governed, and interoperable data platforms.

Vision

Become the leading partner enabling pharma to unify regulated data across domains, making it a trusted, strategic asset.

What We Do
  • Unified Data Platform — Lakehouse architectures (Snowflake, Databricks) that standardize data across EDC, CTMS, PV, Regulatory, Labs, and Manufacturing.
  • Enterprise Governance & MDM — Metadata catalogs, lineage, and master data for consistent, compliant identifiers (e.g., EMA IDMP alignment).
  • Cross‑Functional Integration — Connect safety, clinical, regulatory, and quality for lifecycle‑wide oversight and complex traceability.
  • AI/LLM Readiness — Curated datasets, scalable architectures, and guardrails for compliant AI adoption.
  • Data Write‑Back Enablement — Bi‑directional integrations so validated corrections can flow back to source systems with full audit trails.
  • Analytics Enablement — Make downstream tools (Power BI, Tableau, Spotfire, SAS) run on governed, analysis‑ready data.
Why Pharmastructure
  • Architecture‑first, vendor‑neutral (no ecosystem lock‑in)
  • Compliance by design (GxP, Part 11, GDPR, EMA IDMP)
  • Future‑ready foundation for analytics and AI
  • Bi‑directional data flow with write‑back to source systems
Who We Serve
  • Mid‑ to large‑size pharma with global R&D pipelines
  • Scaling biotech organizations
  • CROs seeking centralized sponsor oversight
  • Heads of Data Management, Clinical IT, Safety/Reg Ops, CIO/CDO
Leadership
  • Alexandra Meyer — CEO. 15+ years building regulated data platforms and leading vendor‑neutral unification initiatives.
  • Rahul Shah — CTO. Designs secure cloud architectures with lineage/MDM and Part 11 controls across Snowflake/Databricks.
  • Elena Petrova — Board. PV & regulatory advisor on IDMP alignment and inspection readiness.
  • David Chen — Board. Clinical ops & MDM advisor focused on lifecycle‑wide data unification.
Meet the team →
Get in Touch

Interested in unifying regulated data and enabling compliant write‑back? Let’s discuss your architecture, governance, and AI/LLM readiness goals.

Contact Us