Sites, subjects, and visits—trial operations with monitoring and document control that sponsors and CROs can inspect.
Run trials with traceability—scheduling, deviations, and monitoring visits under control
We model protocols, arms, and visit schedules with CRUD permissions by role. Query management ties to data clarification; essential documents live in controlled repositories with version and signature expectations. Integration hooks push data to EDC partners where CTMS remains system of operational truth.
01 // THE MANDATE
Sites, subjects, and visits—trial operations with monitoring and document control that sponsors and CROs can inspect.
We model protocols, arms, and visit schedules with CRUD permissions by role. Query management ties to data clarification; essential documents live in controlled repositories with version and signature expectations.
Integration hooks push data to EDC partners where CTMS remains system of operational truth.
02 // ENGINEERING
Development process
Structured phases—from discovery to launch—with clear ownership and handoff points.
Protocol intake (weeks 1–4)
Core CTMS (weeks 4–16)
Validation (weeks 12–22)
Go-live (weeks 20–26)
Operate (ongoing)
03 // CAPABILITIES
Core Capability Matrix
The building blocks of your solution
Studies
protocol versions, sites, investigators.
Subjects
enrollment, consent tracking, visit windows.
Visits
procedures, labs, imaging expectations.
Monitoring
SDV plans, findings, CAPA tracking.
Deviations
log, severity, reporting timelines.
Documents
eTMF handoffs; audit trail.
Supplies
IP shipment tracking hooks.
Reporting
enrollment curves, query aging, site performance.
Compliance
21 CFR Part 11 patterns with validation plan.
API
EDC, IRT partners optional.
04 // DELIVERY LIFECYCLE
The strategic roadmap
Milestones and checkpoints—each phase has a clear outcome before the next begins.
Weeks 1–4: Charter, validation plan.
Weeks 5–14: Sandbox study execution.
Weeks 12–20: Monitoring depth; eTMF bridge.
Weeks 19–26: Production studies.
Ongoing: Multi-study portfolio; analytics.
05 // PRODUCT SCOPING
Choosing your path
Two engagement models—start lean and iterate, or commit to a full platform build from day one.
MVP
Speed & essentialism
Full product
Enterprise maturity
06 // PARTNERSHIP
Why work together
A single accountable partner across strategy, build, and go-live—not a revolving door of vendors.
End-to-end ownership: discovery, architecture, implementation, and launch—with clear communication and production-grade engineering.
- Discovery & alignment
- Systems that scale
- Implementation depth
- Clear comms
07 // CLARITY
Frequently asked
CTMS for operations; EDC for CRF data—integrations are explicit.
08 // MORE SOLUTIONS
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