GxP Compliance
Built with controls for GxP, HIPAA, and 21 CFR Part 11 for audit readiness.
Why ChatGPT for clinical research introduces compliance risks
Generic AI works for pilots but fails under GxP. LyzrGPT provides the secure, compliant AI infrastructure built for validated clinical research workflows.
Maintain GxP compliance
Protecting patient privacy
Accelerate study timelines
Clinical Research:
Governed AI Workflows
LyzrGPT provides a secure, private AI platform designed for GxP environments. It enables teams to automate complex tasks while maintaining total data control and compliance.
Secure Cloud
Deploy into your private cloud or VPC, ensuring data residency and absolute privacy.
Grounded Answers
AI responses are grounded in your approved documentation like SOPs, protocols, and past submissions.
Workflow Agents
Automate medical writing, monitoring reports, and CSR drafting with specialized agents.
eTMF Integration
Connects with CTMS, EDC, and eTMF systems for seamless clinical trial workflows.
Workflows
Workflows
Automate and accelerate critical stages of the clinical trial lifecycle, from protocol design to final submission, with secure and compliant AI agents.
Protocol Authoring
Draft and amend complex clinical protocols faster with AI grounded on regulations.
Trial Monitoring
Automate deviation detection and monitoring report narratives using your trial data.
Medical Writing
Generate draft CSRs, narratives, and safety summaries based on your templates and data.
LyzrGPT is not a replacement for clinical expertise but an accelerator for your expert teams.
The Business Impact of
Compliant AI
Faster Protocol to CSR
Cut down time on authoring, QC, and reviews for all key clinical documents.
Reduce Compliance Risk
Minimize human error and ensure consistency with regulatory standards like ICH-GCP.
Improve Document Quality
Maintain a consistent tone and style across all trial documents and submissions.
Enhance Team Focus
Free your clinical experts from repetitive tasks to focus on science and strategy.
Enterprise Architecture
for Clinical AI
LyzrGPT is built with the security, control, and validation support required for deployment in regulated life sciences environments.
Secure Workspaces
Isolate data, models, and knowledge bases by study, team, or therapeutic area.
Knowledge Grounding
Connect your SOPs, CTMS data, and eTMF to ensure context-aware, accurate AI.
Immutable Audit Trails
Log every query, response, and data access for 21 CFR Part 11 compliance and inspection.
Clinical System APIs
Integrate directly with your existing EDC, CTMS, and eTMF systems via secure APIs.
AI Safety Guardrails
Implement custom rules to prevent PHI leakage and ensure all output is compliant.
LyzrGPT vs. Other AI
for Clinical Trials
| Feature | Generic AI Tools | ChatGPT Enterprise | Lyzr |
|---|---|---|---|
| GxP Compliance | Not designed for | No validation | Built for GxP workloads |
| PHI/PII Safeguards | Shared infrastructure | Limited data control | Private cloud isolation |
| Audit Trails | No immutable logs | Basic user logs | 21 CFR Part 11 compliant |
| Deployment | Public cloud only | Public SaaS model | Private cloud or VPC |
| Data Grounding | Uses public data | Limited RAG control | Grounded in private eTMF |
| Role-Based Access Control | No granular roles | Basic user roles | Per-study access rules |
| Protocol Authoring | Generic text | Non-compliant output | Follows ICH-GCP templates |
| CSR Generation | Unstructured text | Lacks clinical context | Structured, data-driven |
| Monitoring Support | No data integration | Manual data input | Connects to CTMS & EDC |
| Validation Support | Not applicable | Black box model | Validation package provided |
Why Lyzr for Your
Clinical AI?
Built for GxP
Our platform is designed specifically for regulated clinical trial environments.
Private by Design
Your data never leaves your control, ensuring total privacy and data residency.
Clinical Accuracy
Lyzr's RAG technology grounds all outputs in your approved clinical trial documents.
Rapid Adoption
An intuitive platform that your clinical operations and medical writing teams can use now.
Trusted by Leading
Clinical Teams
Lyzr is trusted by innovative CROs, pharmaceutical companies, and clinical research organizations to bring compliant AI into their most critical GxP workflows securely.
LyzrGPT has transformed our medical writing. We've cut CSR drafting time by 40% while improving quality and consistency. The platform's GxP compliance and audit trails gave our quality assurance team the confidence to approve its use in our validated environment.
Sr. Director · Clinical Operations, Global CRO
Zero
Data exfiltration incidents
Get Started With Lyzr For
Trials
Define Scope
We map your GxP use cases and define the specific success criteria for rollout.
Connect Knowledge
Securely link your eTMF, SOPs, and other documents for context-aware AI.
Set Guardrails
Configure access controls, PHI filters, and quality checks for your GxP needs.
Launch & Validate
Deploy to your teams with our support package for documentation and validation.
Common Questions About Secure AI
in Clinical Research
Is using ChatGPT for clinical research GxP compliant?
Standard ChatGPT is not GxP compliant. It lacks the necessary audit trails, validation documentation, and data controls required for regulated environments. LyzrGPT is designed specifically for these requirements, offering a private, auditable, and validatable platform that can be safely deployed within GxP workflows.
What are the risks of ChatGPT for clinical research data?
The main risks are data privacy. Using public AI can expose sensitive patient data (PHI) and proprietary information. LyzrGPT mitigates this by deploying in your private cloud, ensuring data never leaves your control.
How does LyzrGPT integrate with ICH-GCP workflows?
LyzrGPT is grounded in your specific documents, including ICH-GCP guidelines and internal SOPs. This ensures its outputs, from protocol suggestions to CSR drafts, align with required standards, helping maintain compliance throughout the trial lifecycle.
How does LyzrGPT support audit trail needs?
Yes, every action in LyzrGPT is logged in an immutable audit trail, from user queries to data access. This provides transparency needed for inspections and is designed to meet 21 CFR Part 11 requirements.
How does LyzrGPT reduce AI model 'hallucinations'?
Our platform uses Retrieval-Augmented Generation (RAG), grounding every AI response in your verified knowledge base, such as approved protocols and SOPs. This dramatically minimizes the risk of fabricated or inaccurate information, ensuring outputs are reliable and fact-based.
What document types can LyzrGPT work with?
LyzrGPT can process a wide range of clinical documents, including protocols, Investigator's Brochures, informed consent forms, CSRs, and regulatory correspondence. It securely connects to your eTMF or other document repositories to access and utilize this information.
Why not just use a private ChatGPT for clinical research?
Even a private instance of a generic model lacks the purpose-built guardrails for clinical research. LyzrGPT adds critical layers for GxP, including role-based access, validation support, immutable audit trails, and specialized workflows for tasks like protocol authoring.
How does deployment work in our secure private cloud?
LyzrGPT is packaged for deployment within your existing Virtual Private Cloud (VPC) on AWS, Azure, or GCP. This ensures it operates entirely within your security perimeter, inherits your existing controls, and meets all data residency requirements you have.
Can LyzrGPT integrate with our existing CTMS or EDC?
Yes, LyzrGPT offers robust APIs designed to integrate with standard clinical trial systems like CTMS, EDC, and eTMF platforms. This enables seamless data flow, allowing the AI to access real-time trial data for tasks like automated monitoring reports.
How can a CRO roll this out to multiple clients safely?
Lyzr's secure workspace architecture allows CROs to create completely isolated environments for each client. This ensures that data, documents, and AI models for one sponsor are never exposed to another, maintaining strict confidentiality and security across all projects.
Got a use case in mind?
8 weeks from use case to
8 weeks from use case to
agents running in production.
Platform, people and FDEs, all in. Bring your environment. We’ll co-build and stay until it’s
live.