Sovereign AI for regulated science.
Reign for Life Sciences — powered by BioCompute.ai — gives pharma, biotech, and CROs a sovereign AI platform purpose-built for GxP, 21 CFR Part 11, HIPAA, and your IRB. Train and run foundation models on your data — without your data ever leaving your perimeter.
Foundation models can transform discovery — if you can deploy them under GxP.
Pharma and biotech leaders want LLMs writing protocols, agents triaging clinical data, and multimodal models reading slides. But none of that ships if your QA group can't validate it, your regulator can't audit it, or your IRB can't trace it. Public AI services aren't an option for IND data, PHI, or proprietary biology.
21 CFR Part 11 and EU Annex 11 require validated, attributable, contemporaneous, and accurate records of every system interaction — including AI.
Foundation models produce non-deterministic outputs that traditional CSV/CSA frameworks weren't designed to validate.
PHI, IND data, and trade-secret biology cannot be sent to public LLM endpoints under HIPAA, GDPR, or your CDA obligations.
Internal MLOps platforms can't keep up with the cadence of new open-weight models from NVIDIA, Mistral, and Anthropic.
FDA's AI/ML guidance and the EU AI Act both pull clinical-decision-support AI into high-risk regimes.
Your auditors and inspectors expect provenance for every training set, fine-tune, prompt, and output.
How iTmethods serves life sciences
Reign and Forge — the Trust Layer for Enterprise AI — give regulated enterprises the trust, runtime, and sovereign infrastructure they need to move at AI speed.
Sovereign by Construction
Run open-weight foundation models inside your environment — VPC, on-prem, or fully air-gapped. PHI, IND data, and biology never leave.
GxP-Aligned Audit Trail
Every prompt, response, training run, and fine-tune is logged with a 21 CFR Part 11-aligned, tamper-evident record.
Multimodal & Bio-Aware
BioCompute.ai supports protein, genomics, and imaging models — not just text — with the right hardware and evaluation harnesses.
Reign-Powered Governance
Reign Evidence Engine generates the controls and evidence your QA group, IRB, and regulators need on demand.
Validated Workflows
Pre-built validation packages for clinical document drafting, regulatory writing, and lab data analysis — accelerate your CSV/CSA cycle.
NVIDIA Inception Partner
BioCompute.ai is built with NVIDIA's bio-AI stack and runs validated reference architectures for healthcare and life sciences.
Products purpose-built for your stack
Pick what you need. Run it where you need it. Govern everything from one control plane.
Reign
AI Governance
Govern every model, agent, and prompt across your discovery, clinical, and commercial AI estate from one control plane.
- Evidence Engine for FDA, EMA, MHRA, and EU AI Act
- PHI redaction and prompt-injection defense
- Three-lines-friendly: science, QA, and audit
Forge
Managed Runtime
Validated DevOps platform for the engineers who build your scientific software. SOC 2 Type II, GxP-deployable.
- Managed Jenkins, GitLab, JFrog, SonarQube, and more
- Validation-ready CI/CD with audit hooks
- Air-gapped and private-cloud deployments
Reign for Life Sciences
Powered by BioCompute.ai
The deep-specialty configuration of Reign for pharma, biotech, and CROs. Foundation models on your data, in your environment — protein, genomics, imaging, and clinical text.
- Air-gapped and on-prem foundation model deployment
- Multimodal: text, protein, genomics, and imaging
- GxP, 21 CFR Part 11, HIPAA, GDPR aligned by design
Built for the regulations you actually face
Evidence is generated automatically. Auditors, regulators, and internal risk teams get what they need — without your engineers writing another spreadsheet.
Electronic records and signatures for AI workflows, with attributable, contemporaneous, and tamper-evident logs.
Validation-ready architectures for AI used in development, lab, manufacturing, and clinical settings.
PHI never leaves your perimeter. BAA-friendly deployment models, including air-gapped.
Data residency, lawful-basis tracking, and right-to-explanation built into the AI Gateway and Evidence Engine.
Clinical decision support, diagnostic AI, and HR-screening models classified, documented, and conformity-ready.
Aligned with FDA's PCCP and good machine learning practice for software as a medical device.
Where teams in life sciences are starting
Regulatory & medical writing
LLMs drafting CSRs, protocols, and INDs — with provenance every QA reviewer and inspector will accept.
Clinical operations agents
Governed agents that triage adverse events, normalize lab data, and summarize EDC outputs without ever exposing PHI.
Discovery & translational AI
Run protein, genomics, and imaging foundation models on your private compute — sovereign, fast, and reproducible.
Pharmacovigilance copilots
Reign governs every prompt; BioCompute.ai runs the model; your safety team owns the audit trail.
Validated developer platform
Forge gives your scientific software engineers a SOC 2 / GxP-deployable CI/CD platform — without the multi-year build.
CRO / sponsor data exchange
Sovereign deployment lets sponsors and CROs collaborate on AI workflows without commingling regulated data.
Become a design partner. Help define sovereign AI for regulated science.
We are building Reign for Life Sciences (powered by BioCompute.ai) with a small cohort of pharma, biotech, and CRO leaders. Cohort members shape the validation packages, the GxP-aligned controls, and the multimodal model support — and get early access in their environment.
Outcomes we are targeting with the cohort
These are the outcomes the design partner cohort is working toward together. Not historical claims — co-developed targets, transparently tracked.
Scientists & developers
Foundation models on your data, in your environment — without the procurement, security, or QA marathon.
- Open-weight LLM, protein, and imaging models under one runtime
- Cursor, Copilot, and internal MCP servers governed by Reign
- Reproducible workflows with versioned prompts, datasets, and outputs
QA, regulatory, & IRB
Validated workflows and Annex 11-aligned evidence — packaged the way inspectors and auditors actually want them.
- 21 CFR Part 11 / EU Annex 11 aligned audit trails
- Pre-built validation packages for medical writing and lab workflows
- Provenance for every training set, fine-tune, prompt, and output
CSO, CMO, CIO, and the board
A defensible position in front of the FDA, EMA, and your investors — and AI moving fast enough to actually matter for the pipeline.
- Air-gapped sovereign deployment for the most sensitive programs
- Joint reference architectures with NVIDIA's bio-AI stack
- Co-developed roadmap aligned with discovery, clinical, and regulatory needs
“Pharma cannot ship AI workflows that QA cannot validate, IRB cannot trace, or the inspector cannot audit. The cohort is being built to make those three things possible at the same time as discovery moves at AI speed.”
— iTmethods Design Partner Cohort thesis
LIFE SCIENCES FAQ
Frequently asked questions
- Which life-sciences regulations does Reign address?
- Reign for Life Sciences is fluent in FDA PCCP (Predetermined Change Control Plans), 21 CFR Part 11, GxP (GLP, GCP, GMP), ICH Q9 quality risk management, EU GMP Annex 11, EU AI Act, ISO 42001, NIST AI RMF, and ALCOA+ data integrity. Assurance Packs map to IND, NDA, BLA, and PCCP submissions.
- What's the relationship between Reign and BioCompute.ai?
- BioCompute.ai is the deep-specialty sovereign AI platform for pharma, biotech, and CROs. Reign for Life Sciences is the vertical configuration of Reign — same four-component Spine (AI Gateway, Model Risk Validation, Audit Ledger, Assurance Packs) — extended with BioCompute.ai capabilities for life-sciences workflows.
- Does Reign support 21 CFR Part 11 e-signatures and audit trails?
- Yes. The Audit Ledger (CAVR) produces tamper-evident records that align with 21 CFR Part 11 audit-trail requirements. Combined with Reign Assurance Packs, e-signature workflows and validation evidence are captured continuously rather than reconstructed at audit time.
- Can Reign run in air-gapped environments for sensitive programs?
- Yes. Sovereignty is a deployment-tier property: SaaS, dedicated, customer cloud (AWS / Azure / GCP), or fully air-gapped. The most sensitive discovery and clinical programs deploy air-gapped without losing the governance Spine.
- How does Reign help with FDA PCCP for AI/ML medical devices?
- Reign Model Risk Validation maintains an approved-model registry with cryptographic versioning, predetermined change-control packets, drift detection, and validation harnesses. Every change packet feeds the Audit Ledger; Assurance Packs render PCCP-aligned evidence ready for submission.
- Is Reign for Life Sciences generally available?
- Reign is in Design Partner phase — engagement is qualified cohort by cohort with regulated life-sciences organizations. Forge (Managed Runtime + Modern DevOps) is GA. Life-sciences organizations interested in Reign apply to the Design Partner Program.