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Unified Governance. $3–5M Recovered. Per Trial. Submission Accelerated.
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Outcomes
What we did
200+
Portfolio visibility
40–50%
Manual coordination cycles
$3–5M
Governance across all teams
8–12 Wks
Milestone predictability
About Company
A large pharma sponsor managing 200+ global trials faced a core execution constraint: coordination across CROs did not translate into consistent execution at scale.
Data signals were fragmented and acted on too late, leading to delayed risk resolution. Database lock timelines slipped by 6–8 months, deferring $3–5M in submission value per study and reducing portfolio predictability.
The issue was not visibility. It was executing on signals early enough to maintain timeline control across a global portfolio.
Data signals were fragmented and acted on too late, leading to delayed risk resolution. Database lock timelines slipped by 6–8 months, deferring $3–5M in submission value per study and reducing portfolio predictability.
The issue was not visibility. It was executing on signals early enough to maintain timeline control across a global portfolio.
Challenges
Key Barriers
to Trial Execution
No Portfolio View
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No unified view across 200+ trials
Risks identified too late
Higher cost and timeline impact
Manual Submission Prep
3–4 months per study
Issues surface too late to act
Manual processes and data remediation
Limited Readiness Visibility
Unclear submission readiness
Frequent cross-team escalations
DB Lock Slippage
6–8 month delays in DB lock
$3–5M deferred submission value per study
Static KRI Thresholds
Emerging risks not captured
Core platform
Operational Solution
Maxis AI Agentic Workflows — Under Human Oversight Throughout
AI for Data Quality & RBQM
Unified view across 200+ trials
Early risk detection
Portfolio risk 8–12 weeks early
AI for Clinical Data Management
Shift to strategic decision-making
Human oversight maintained
60–70% queries auto-resolved
60–70% queries auto-resolved
AI for Statistical Programming
SAP timelines reduced from weeks to days
Submission prep cut to 6–8 weeks
$3–5M value recovered per trial
Maxis AI operated as a governed and supervised execution layer within existing systems throughout.
Core platform
Measured Impact
Quantified Outcomes After Deploying Maxis AI’s Agentic Workflows
| Metric | Before Agentic AI | After Agentic AI |
|---|---|---|
| Biometrics Oversight | No unified view across 200+ trials; risks identified weeks too late | Single source of truth; risks flagged 8–12 weeks in advance across all CRO partners |
| Database Lock | 6–8 months per study; $3–5M deferred submission value per delay | Accelerated 40–50%; 3–4 months; $3–5M value recovered per trial |
| Submission Prep | 3–4 months manual preparation per study | 6–8 weeks; $200K–$400K programming savings per trial |
| Portfolio Visibility | Milestone dates variable; leadership lacked portfolio visibility | Continuous real-time oversight; predictable milestone delivery |
| Escalations | Escalation-heavy; submission readiness uncertain across programs | Milestone confidence restored; $3–5M value recovered per study via earlier submission |
Outcomes
Clinical leadership reported restored confidence in portfolio submission predictability. Risks identified and resolved weeks ahead of milestone impact.
Database lock accelerated 40–50% per study — $3–5M total value recovered
Submission prep cut from 3–4 months to 6–8 weeks
Unified view across all 200+ trials and CRO partners
Risks flagged 8–12 weeks in advance — escalation cycles eliminated
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