Solutions · Small Pharma
Phase 2 Delivered. No Biometrics Build. DB Lock in 3–4 Months
Maxis AI expanded Phase 2 biometrics execution capacity, reducing manual query burden by 60-70% without requiring a full permanent function buildout.
3–4 Months
DB lock vs 6–8 months traditional
40–50%
Faster database lock
60–70%
Queries auto-resolved
30%
Cost savings vs. traditional CDM
WHO IT IS
The Context
A Series B oncology biotech moving into Phase 2 did not have the internal biometrics infrastructure required to support a more complex, multi-site trial.
The company had clinical momentum but lacked mature in-house data management, RBQM, and statistical programming capacity. Building those functions internally would add cost, time, and execution risk at a stage where investor timelines and study-readiness milestones were already under pressure.
The challenge was not simply outsourcing. The company needed a governed execution layer that could support data cleaning, query resolution, RBQM oversight, and database lock readiness without requiring a full permanent biometrics buildout.
Challenges
Key barriers to Trial Execution
No Mature Biometrics Infrastructure
- Limited in-house data management capacity
- No mature query resolution workflows
- Statistical programming support needed for downstream readiness
Data Fragmentation
- Clinical data spread across systems and sources
- 5,000–50,000 query exposure per trial
- Limited unified visibility into data quality risks
DB Lock Timeline Risk
- 6–8 months DB lock projection
- Manual reconciliation delays readiness
- Milestones exposed to downstream delays
RBQM Requirement
- ICH E6(R3) RBQM required
- Static KRIs may miss risks
- Governed oversight and audit traceability needed from study start
Operational solution
Maxis AI agentic workflows — under human oversight throughout
AI for Clinical Data Management
- AI-assisted cleaning and validation
- Routine query resolution
- Unified cross-source visibility
Outcome
60–70% auto-resolved routine queries
AI for RBQM
- Predictive risk signals
- Governed central monitoring
- Audit-ready oversight
Outcome
ICH E6(R3)-aligned RBQM oversight
Biometrics Capacity Without Full Buildout
- Expanded execution capacity
- Focus on review and oversight
- Reduced CDM buildout needs
Outcome
30% cost savings vs. traditional CDM
Maxis AI operates as a governed and supervised execution layer within existing systems throughout.
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Measured impact
Quantified outcomes after deploying Maxis AI's agentic workflows
| Metric | Before Maxis AI | After Maxis AI |
|---|---|---|
| Database Readiness | 6–8-month database lock timeline | Database lock in 3–4 months; 40–50% faster |
| Query Burden | High manual review burden | 60–70% of routine queries auto-resolved |
| Biometrics Capability | Limited internal CDM infrastructure | Expanded execution capacity without full buildout |
| Cost Model | Traditional manual CDM model | 30% cost savings |
| RBQM Oversight | Static review cycles | ICH E6(R3)-aligned RBQM oversight with audit traceability |
Outcome
Quantified Benefits
Phase 2 execution was supported without a full permanent biometrics buildout. Database lock readiness improved from the traditional 6–8 month cycle to 3–4 months, while routine query handling and data-quality workflows moved under supervised AI execution.
DB lock in 3–4 months vs. 6–8 months traditional timeline
60–70% queries auto-resolved under expert oversight
40–50% faster database lock
Expanded biometrics capacity without full team buildout
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