Legal Disclaimer

1. Product Classification

ClinicalOS is a decision support tool designed to assist clinical operations professionals in managing clinical trials. ClinicalOS is not a medical device, not a GxP system of record, and not intended to replace the professional judgment of qualified clinical research personnel.

All AI-generated outputs, scores, recommendations, and analyses provided by ClinicalOS are for informational and decision-support purposes only. They do not constitute medical, regulatory, legal, or clinical advice.

2. Limitation of Liability

ClinicalOS and its operators shall not be held liable for any clinical, regulatory, or business decisions made based on the outputs of this platform. The sponsor and their qualified personnel retain full responsibility for all clinical trial decisions, including but not limited to:

• Site selection and qualification
• Investigator selection and oversight
• Protocol design and amendments
• Patient enrollment and consent
• Safety reporting and pharmacovigilance
• Regulatory submissions and filings
• Data integrity and quality assurance

3. AI and Machine Learning Disclaimer

ClinicalOS uses artificial intelligence and machine learning models to generate recommendations and predictions. These models:

• May produce inaccurate, incomplete, or biased outputs
• Are trained on historical data that may not reflect current conditions
• Should not be used as the sole basis for any clinical or regulatory decision
• Require human oversight and validation before any action is taken
• Are subject to ongoing refinement and may change without notice

Users must independently verify all AI-generated outputs against primary sources and apply professional judgment before relying on any recommendation.

4. Data Sources Disclaimer

ClinicalOS aggregates data from publicly available sources including ClinicalTrials.gov, PubMed, EudraCT, and WHO ICTRP. While we strive to maintain data accuracy and currency:

• Public registry data may be incomplete, outdated, or contain errors
• Data synchronization may introduce delays of up to 48 hours
• Scoring models are based on available data and may not capture all relevant factors
• Users should verify critical data points directly with the source registries

5. Regulatory Status

ClinicalOS Module 1 (Site & Investigator Intelligence) has undergone internal Computer System Validation (CSV) following GAMP 5 Category 5 methodology. The complete CSV documentation pack (URS, FS, DS, Traceability Matrix, IQ, OQ, PQ) is available at /legal/csv. The platform is designed with regulatory awareness (GDPR, 21 CFR Part 11, ICH E6 R3). External certification (SOC 2, ISO 27001) is planned.

Organizations using ClinicalOS in GxP-regulated environments should review the CSV documentation and perform their own qualification activities in accordance with their internal procedures.

6. Module Classification

Each ClinicalOS module carries a classification indicating its maturity and intended use:

7. Contact Information

For questions about this disclaimer, the regulatory status of ClinicalOS, or to report concerns: