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Phase 1 Trial: First Patient In <100 Days. Under $400K.
Outcomes
What we did
<100
First patient in
45%
Faster startup
2–3x
Enrollment conversion
50%
Faster DB lock
<$400K
Fixed price vs $2–5M
About Company
A Boston-basedoncology biotech advancing its first asset into a Phase 1 trial faced astructural execution gap.
With no internalclinical operations team, execution was fragmented across protocol design, datamanagement, statistical programming, and medical writing without a single pointof accountability.
A traditional CROproposal of $3M+ over 18 months placed significant pressure on cash runway.
At the same time, ICH E6(R3) requirementsrequired RBQM to be operational and audit-ready before first patient, nottreated as a post-hoc compliance exercise.
With no internalclinical operations team, execution was fragmented across protocol design, datamanagement, statistical programming, and medical writing without a single pointof accountability.
A traditional CROproposal of $3M+ over 18 months placed significant pressure on cash runway.
At the same time, ICH E6(R3) requirementsrequired RBQM to be operational and audit-ready before first patient, nottreated as a post-hoc compliance exercise.
Challenges
Key Barriers
to Trial Execution
Startup
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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
Core platform
Operational Solution
Maxis AI Agentic Workflows — Under Human Oversight Throughout
AI Accelerated Startup & IRB
Fragmented data across EDC, eCOA, lab, safety
Static KRI thresholds
Risks detected too late
↓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
ICHE6(R3) compliant
Phase 1 Accelerator
End-to-end execution from design to CSR
One team, one contract
Fixed price under $400K
2–3× enrollment uplift
Maxis AI operated as a governed and supervised execution layer within existing systems throughout.
Core platform
Measured Impact
Quantified Outcomes After Deploying Maxis AI’sAgentic Workflows
| Metric | Before Agentic AI | After Agentic AI |
|---|---|---|
| Startup Duration | ~28 weeks (industry avg: 24.8 wks) | ~15–16 weeks - up to 45% reduction; first patient in under 100 days |
| Enrollment Conversion | ~29.5% screening-to-enrollment | 60–70% - 2–3× improvement via structured AI patient matching |
| Query Volume | Manual — consuming team capacity | Reduced by 60–75%; predictive risk signals 8–12 weeks in advance |
| Database Lock | Delayed in 30–40% of trials | Up to 50% faster; submission advanced 3–4 months = $3–5M total value |
| Phase 1 Cost & Timeline | $2–5M avg CRO cost; 15–18 month timeline | Under $400K fixed price; delivered in 9–12 months |
Outcomes
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 firstreview - fully ICH E6(R3) compliant
Zero vendor complexity -one team, one contract
Clear pathway to Phase 2/3under the same execution model
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