AI-Powered Clinical Intelligence for Pharmaceutical Organizations
Project Foresight delivers governed signal detection, protocol optimization, regulatory compliance AI, and cross-system clinical data analysis: validated at 96/100 EXCELLENT with SHA-256 audit trails on every output.
Foresight is a product of Mentis Health, a Bespoke Mentis company.
Performance Validated Across Six Clinical Cutoffs
Four Failures Costing Pharma Billions Every Year
The clinical development process is broken in predictable ways. These are not edge cases. They are structural, recurring, and expensive.
Manual Protocol Analysis
Clinical protocol review is performed manually by overstretched research teams. Deviations surface weeks after they occur. Every hour of delay compounds downstream risk.
Protocol deviations detected late cost an average of $600K per incident in CRO delays
Slow Signal Detection
Adverse event signals buried across FAERS, literature, and clinical databases take weeks to surface. By the time analysis is complete, the signal has grown.
Mean time from FAERS signal emergence to detection: 14-28 days with manual review
Regulatory Burden
21 CFR Part 11, GCP compliance, and FDA audit readiness each demand documentation at a scale most clinical teams cannot sustain. Audit gaps accumulate silently.
FDA 483 observations related to data integrity cost on average $1.2M to remediate
Siloed Clinical Data
Trial data sits in disconnected systems: EDC, CTMS, safety databases, and lab systems that never communicate. Cross-functional decisions get made on incomplete pictures.
Data silos add an average of 6-9 months to Phase III trial completion timelines
What Project Foresight Does
Four governed intelligence capabilities designed for the specific failure modes of pharmaceutical clinical development.
Signal Intelligence
Real-time detection of adverse event signals, competitive pipeline movements, and regulatory flag patterns across FAERS, ClinicalTrials.gov, and global regulatory feeds. Every signal is source-attributed and SHA-256 verified at the moment of detection.
Protocol Optimization
AI-assisted protocol analysis that compares your design against historical trial outcomes, FDA precedent, and NCCN patterns. Surfaces deviation risk, endpoint selection vulnerability, and inclusion or exclusion criteria gaps before IND submission.
Regulatory Compliance AI
21 CFR Part 11 electronic records compliance, GCP audit trail maintenance, and FDA audit readiness scoring built into every output. Constitutional AI governance ensures no output bypasses the compliance layer.
Clinical Data Analysis
Governed synthesis of cross-system clinical data: EDC, CTMS, lab systems, and safety databases unified into a single auditable intelligence layer. Outputs are typed, citation-bound, and cryptographically traceable to source records.
Five-Step Clinical Intelligence Flow
From raw clinical data to a SHA-256 verified, audit-ready intelligence output: every step is governed, traceable, and reproducible.
Data Ingestion
Foresight ingests structured and unstructured clinical data from your connected systems: EDC exports, CTMS feeds, FAERS reports, ClinicalTrials.gov, PubMed, and regulatory filings. Every record receives a cryptographic fingerprint at ingestion.
Signal Detection
The Signal Intelligence core continuously scans ingested data for adverse event patterns, protocol deviation indicators, competitor regulatory activity, and emerging safety signals. Detections are scored by severity and regulatory exposure level.
Governed Analysis
Bounded retrieval reasoning operates only on verified, source-attributed context. No output can be surfaced without a traceable citation chain. Confidence bounds are displayed on all outputs. Human review gates enforce approval at defined clinical decision points.
Structured Recommendation
Intelligence outputs are typed and structured: protocol risk assessments, signal escalation reports, regulatory compliance scorecards, and competitive landscape briefs. Each output carries source citations, knowledge cutoff documentation, and governance session ID.
Immutable Audit Trail
Every query, every output, and every decision is permanently recorded in a SHA-256 hash-chained evidence ledger. The record is tamper-evident by design and regulator-ready for 21 CFR Part 11 submissions, FDA audits, and GCP compliance reviews.
Built for Regulated Environments
Governance is not a feature added to Foresight. It is the operating foundation. Every compliance standard below is addressed at the architecture layer, not through post-processing or documentation workarounds.
21 CFR Part 11
Electronic records and electronic signatures. Foresight audit trails satisfy FDA requirements for clinical data integrity and electronic record authenticity.
HIPAA-Aware Architecture
Customer-controlled data model. Patient records and PHI remain within your trust boundary and are never used for model training or cross-client inference.
GCP Compliance
Good Clinical Practice documentation standards applied to AI-generated outputs. Every intelligence product is traceable, versioned, and audit-ready for trial inspection.
FDA Audit Readiness
Audit trail format, evidence chain integrity, and output documentation designed to satisfy FDA inspection requirements and respond to 483 observations.
ISO 14155 Support
Clinical investigation of medical devices. Foresight supports the documentation, risk assessment, and protocol review requirements of ISO 14155 compliant trials.
SHA-256 Evidence Chain
Every output is cryptographically fingerprinted. Any output can be verified as unmodified at any point after generation: tamper-evident by design, regulator-ready by architecture.
Validation Documentation Available
All Foresight engagements include a validation documentation package: User Requirements Specification (URS), Functional Requirements Specification (FRS), IQ/OQ/PQ templates, 21 CFR Part 11 compliance matrix, data use prohibition, and audit rights SLA. Bespoke Mentis supports your QA/RA team through the Computer Software Assurance (CSA) process.
Foresight vs the Alternatives
| Capability | Project Foresight | Manual Processes | Legacy Clinical Systems |
|---|---|---|---|
| Audit-ready output documentation | |||
| SHA-256 cryptographic evidence chain | |||
| Real-time adverse event signal detection | Partial | ||
| 21 CFR Part 11 electronic records compliance | Partial | ||
| Cross-system clinical data unification | |||
| AI-assisted protocol optimization | |||
| FDA audit readiness scoring | |||
| Zero-contamination knowledge cutoffs | |||
| Constitutional AI governance layer | |||
| Citation-bound intelligence outputs | Partial |
Built for Every Tier of Life Sciences
Pharmaceutical Companies
Medical affairs, regulatory affairs, and market access teams at clinical-stage to commercial pharma organizations. Foresight replaces fragmented CI tools and manual protocol review with a single governed intelligence platform.
Contract Research Organizations
CROs managing multi-sponsor trial portfolios need cross-trial signal detection, protocol compliance tracking, and audit-ready documentation at scale. Foresight provides the intelligence infrastructure without the headcount.
Biotech Startups
Early-stage biotech with a single asset and lean teams cannot afford a full CI function. Foresight delivers enterprise-grade intelligence at a fraction of the cost of traditional CI platforms, with governance built in from day one.
Academic Medical Centers
Research institutions conducting investigator-initiated trials need protocol optimization, regulatory compliance support, and signal detection capabilities without dedicated commercial software budgets.
Medical Device Companies
ISO 14155 clinical investigation requirements and FDA 510(k) or PMA submission intelligence. Foresight supports device trial protocol review, adverse event monitoring, and regulatory submission intelligence.
Request Pharma AI Demo
Foresight is available for qualified pharmaceutical and biotechnology organizations. Schedule a demo tailored to your therapeutic area and use case. Validation documentation and compliance architecture briefings available on request.
Contact for pricing: Scoped Pilot (60-day) · Intelligence Pilot (year one) · Commercial Platform · Constitutional Enterprise
Common Questions