Beta v1.0
Capital-Efficient CRO Engine & FDA Validation Architecture
Eliminating legacy CRO bloat, opaque invoicing, and redundant software overhead. Led directly by Mohammad Alajarmeh, M.D., Eunoia Health provides precision trial management, regulatory auditing, and endpoint verification across South Florida and the Boston-Worcester Corridor.
Flexible, Transparent Engagement Models
Match your trial cash flow directly with project scope and development phase.
Embedded Senior Specialist
Flat Hourly Advisory Model
Direct clinical operations oversight for preclinical biopharma startups and emerging innovators needing expert protocol design or data auditing without adding permanent executive headcount.
- 1099 Consulting Agreement
- Predictable Flat Hourly Billing
- Direct M.D. Command & Protocol Review
Extended Project Team
Lean Deployment Model
Direct pass-through access to dedicated trial contractors—including biostatisticians, clinical monitors (CRAs), and medical writers—billed transparently at cost plus a lean management fee.
- Direct Pass-Through Billing
- Hand-Selected Contractor Talent
- Zero Opaque Invoicing Traps
Milestone Contract Billing
Fixed-Price Project Blocks
Structured, deliverable-based execution for defined clinical trial phases (Phase I–IV) and formal FDA submissions (510(k), PMA, IND), ensuring complete budget predictability.
- Fixed-Price Project Block Execution
- Mapped Strictly to Audit Milestones
- Audit-Proof Compliance Packages
Regulatory Auditing & Execution Pillars
High-integrity clinical execution designed to shield sponsors from FDA delays.
Regulatory Compliance Auditing
Dissecting foreign specs, technical files, and clinical outputs to verify signal precision and eliminate gaps before FDA submission.
- FDA Pre-Submission Readiness
- Orphan Drug & Small Business Waivers
- Signal & Endpoint Precision Audits
Protocol Architecture & FDA Submissions
Designing adaptive trial protocols, statistical analysis plans (SAP), and regulatory dossiers for FDA 510(k), PMA, and IND clearances.
- FDA 510(k), PMA, & IND Filings
- Human Physiology & Safety Protocols
- Target Endpoint Selection
Clinical Operations & Site Liaison
On-the-ground site liaison management across South Florida and Boston-Worcester clinical networks to ensure primary data purity.
- Pre-Screened Investigator Networks
- Risk-Based CRA Site Monitoring
- Rapid CTA & Budget Contracting
Phytochemistry & Natural Product R&D
Applying academic chemistry methodologies to isolate, synthesize, and validate active botanical compounds for commercial applications.
- Botanical Extractions & Synthesis
- Active Compound Isolation
- Bioactive Validation Assays
Data Integrity & Source Auditing
Protecting source data purity through rigorous oversight, ensuring zero exploratory bias and full CDISC/SDTM formatting.
- 21 CFR Part 11 Validation
- Data Dignity Enforcement
- Source Data Verification (SDV)
Stalled & Neglected Asset Rescue
Re-engineering deprioritized biopharma assets and neglected medical devices through advanced computational modeling and AI.
- Post-Hoc Signal Re-Analysis
- Repurposing Feasibility Review
- Fast-Track Clinical Pivots
Request Proposal or Regulatory Audit
Submissions route directly to 01_Commercial_Leads_CRO_Services