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Maxis AI — THE FIRST AI WORKFORCE IN CLINICAL TRIALS
For Directors of Clinical Data Management

Supervised Execution for Clinical Data Management

Move from reactive query management to continuous, AI-supervised data readiness.

A Day in the Life of a Director of Data Management

The query backlog grew overnight. Lab and EDC reconciliation surfaced ten new discrepancies. A site is two days from a monitoring visit and the data isn't clean. Database lock is six weeks away across two studies.

The team is skilled. The systems work. The volume of repetitive, manual review is what is slipping the timeline. Every cycle still depends on senior hands.

Maxis AI gives data management structured throughput — without compromising validation or audit traceability.

08:00Daily Standup
11:30Risk Review
14:00CRO Sync
16:45Board Briefing

Human-in-the-loop validation · Audit traceability · Governed execution

Pressures

The Pressures Data Management Leaders Carry Every Day

Query Volume At Scale

Rising data volumes drive query counts and reconciliation cycles faster than teams can resolve them — backlog becomes the constraint.

Cross-System Complexity

Reconciling EDC, lab, safety and imaging sources is largely manual and creates fragile, person-dependent workflows.

Database Lock Pressure

Documentation, re-validation and clean-up extend the path from data entry to lock — squeezing every downstream function.

The constraint isn't capability — it's execution capacity around the data.

Industry Reality

Industry Reality

  • Trial data volume continues to grow across more sources and modalities.
  • Query and reconciliation expectations rise with regulatory scrutiny.
  • Skilled DM resources are scarce and difficult to scale linearly.
  • Late-stage clean-up creates disproportionate timeline risk.
  • Inspection-readiness must hold across every workflow, every time.

Data management is being asked to scale review — not just monitoring.

How Maxis AI Is Built for Clinical Data Management

Maxis AI deploys supervised agents inside data management workflows — query generation and routing, edit-check review, cross-system reconciliation and database-lock preparation. Validation checkpoints and audit logs are preserved end-to-end.

Data managers stop chasing repetitive cycles and return to higher-value review and oversight. Every action is logged with full context and remains inspection-ready.

How it Works

From Pain to Outcome: How Maxis AI Works for You

Query backlog grows faster than resolution.

Context-aware query agents with prioritization and routing.

Reduced backlog and faster resolution cycles.

Manual reconciliation across multiple sources.

Cross-system reconciliation agents under defined validation.

Continuous reconciliation across EDC, lab, safety and imaging.

Edit-check review consumes senior DM time.

Automated edit-check review with human-in-the-loop oversight.

Continuous data-quality monitoring across studies.

Documentation extends database lock timelines.

Auto-captured action logs and validation traces.

Compressed database-lock cycles with audit traceability.

Late-stage findings disrupt downstream functions.

Continuous monitoring with structured intervention.

Earlier surfacing of issues and fewer late-stage surprises.

Case Study

Reduced Database Lock Time by 40–50%, Accelerating Trial Data Readiness

With 5,000–50,000 queries per trial and 80% of team capacity tied to manual cleaning, clinical data management needed faster execution. Read how database lock timelines were brought under control.

55%

Lower Query Backlog

30%

Faster Database Lock

100%

Audit Traceability

0

Workflow Disruption

FAQ

All You Need to Know

Supervised agents embed across cleaning, reconciliation, edit-check review and query workflows to reduce backlog and accelerate database lock.

Yes. Every action is logged with full context. Validation checkpoints remain intact while repetitive workload is reduced.

No. Maxis AI integrates within existing governance and validation frameworks across EDC and source systems.

Query throughput, cross-system reconciliation and database-lock cycle time.

Yes. As data volume and complexity grow, supervised automation strengthens consistency and predictability.

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Explore the Agentic AI Platform.

See how AI agents are transforming study startup, data management, oversight, and regulatory submissions.