CRO SERVICES
Phase 1 Trial: Protocol to Database Lock in 9-12 months. Trial Cost Under $400K.
Maxis AI helped an oncology biotech accelerate study startup by 45% through one governed Phase 1 execution model - from protocol through database lock.
45%
Faster startup
2–3×
Enrollment conversion
40-50%
Faster DB lock
<$400K
Fixed price vs $2–5M
WHO IT IS
The Context
A Boston-based oncology biotech advancing its first asset into a Phase 1 trial faced a structural execution gap.
With no internal clinical operations team, execution was fragmented across protocol design, data management, statistical programming, and medical writing without a single point of accountability.
A traditional CRO proposal of $2-5M+ over 18 months placed significant pressure on cash runway.
At the same time, ICH E6(R3) requirements required RBQM to be operational and audit-ready before first patient — not treated as a post-hoc compliance exercise.
Challenges
Key barriers to trial execution
Startup
- Prolonged IRB drafting cycles
- Fragmented site tracking
- Late-stage escalation after timeline slips
Enrollment
- Only 29.5% patient conversion
- Low screening-to-enrollment rate
- Slowed cohort progression
Data Quality
- Fragmented data across EDC, eCOA, lab, safety
- Static KRI thresholds
- Risks detected too late
Compliance
- ICH E6(R3) RBQM requirements active
- No system in place pre-trial
Cost & Coordination
- $2–5M CRO costs impacting runway
- 4–5 vendors managed separately
- No single point of accountability
Operational solution
Maxis AI agentic workflows — under human oversight throughout
AI Accelerated Startup & IRB
- Protocol-aware IRB packages auto-generated
- Real-time site tracking
- Deviations flagged within 2–3 days
Outcome
45% faster startup
AI Data Quality & RBQM Hub
- Unified data layer across all systems
- Queries resolved under human oversight
- Predictive risk signals 8–12 weeks early
Outcome
40-50% faster DB Lock
Phase 1 Accelerator
- End-to-end execution from design to CSR
- One team, one contract
- Fixed price under $400K
Outcome
2–3× enrollment uplift
Maxis AI operates as a governed and supervised execution layer within existing systems throughout.
See it on your study
Curious how this could work for your Phase 1 protocol?
We'll review your study workflow, identify execution gaps, and map where AI agents can deliver measurable operational impact in a 30-minute working session.
Measured impact
Quantified outcomes after deploying Maxis AI's agentic workflows
| Metric | Before Maxis AI | After Maxis AI |
|---|---|---|
| Startup Duration | ~28 weeks traditional startup cycle | ~15–16 weeks - up to 45% faster startup execution |
| Enrollment Conversion | ~29.5% screening-to-enrollment | 60–70% — 2–3× improvement via structured AI patient matching |
| Query Volume | Manual review consuming team capacity | Reduced by 60–75%; predictive risk signals 8–12 weeks in advance |
| Database Lock | Delayed in 30–40% of trials | 40–50% faster - driven by AI-assisted data cleaning; estimated $3–5M in deferred trial value from earlier submission |
| Phase 1 Cost & Timeline | $2–5M avg CRO cost; 15–18 month protocol-to-DB-lock timeline | Under $400K fixed price; protocol to DB lock delivered in 9–12 months |
CONCLUSION
Quantified Benefits
Proof-of-concept delivered in 9–12 months at under $400K versus $2–5M traditional CRO cost — one team, one contract.
Board confidence maintained through real-time dashboards and proactive safety monitoring
RBQM audit-ready on first review — fully ICH E6(R3) compliant
Zero vendor complexity — one team, one contract
Clear pathway to Phase 2/3 under the same execution model
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