Protocol support
Organize draft inputs, comments, and change requests around the latest version.
Clinical operations
Clinical Development
Help clinical teams stay on top of protocol work, site follow-up, and recurring documentation without losing traceability or sponsor oversight.
Clinical coordination with sponsor control points intact
The goal is not autonomous clinical decision-making; it is reliable coordination, summarization, and document prep around sponsor-owned workflows.
Operating layers
Govern · Prepare · Build · Validate · Scale
Decision rights
Human-owned, evidence-backed.
Concrete workflow example
Site-startup blocker packet
Fewer missed handoffs across CRO, sponsor, site, and document teams.
Inputs
- • CTMS milestones
- • eTMF expected documents
- • site tracker
- • meeting notes
- • open action logs
Agent tasks
- • identify missing startup items
- • summarize blockers
- • draft owner/action list
- • prepare sponsor review packet
- • monitor aging items
Evidence output
- • tracker snapshot
- • source document references
- • action history
- • review record
Where agents fit
Useful work, not magical work.
These are the places where a governed agent saves time without taking over the decision.
Site-startup coordination
Track missing items, follow-up actions, and handoff dependencies across teams.
Study trackers
Keep recurring operational updates clean and current from existing systems.
Meeting follow-up
Turn clinical meetings into action lists, owners, and due dates.
Use cases
What the team can actually do.
Draft study status summaries from existing trackers and meeting notes.
Surface site-startup blockers and unresolved dependencies.
Assemble protocol review packets for sponsor review.
Organize investigator meeting follow-up actions and owners.
Prepare clean handoff notes for CRO, sponsor, and vendor teams.
Human decision points
Humans own the regulated decisions.
site readiness
protocol interpretation
sponsor/CRO escalation
external communication
What agents cannot do
No hidden authority.
make eligibility decisions
perform medical judgment
approve site activation
override sponsor processes
Controls and governance
The brakes are part of the design.
If the workflow touches regulated records or operational decisions, the controls need to be visible, testable, and boring.
Agents stay out of medical judgment, eligibility decisions, and safety conclusions.
Clinical documents are reviewed against sponsor-approved templates and workflows.
Source systems and version control are explicit in every output.
Escalations are required when data gaps affect timelines or quality.
Human team role
Domain specialists stay accountable.
Clinical operations, medical, and sponsor leads retain judgment, approve the content, and manage external communications.
Common systems
CTMSeTMFstudy trackersdocument repositoriesmeeting/action logs
Other domains
Explore related agentic workflows.
Next step
Pick the first workflow worth doing properly.
Start with one bounded use case, prove the controls, and then decide whether the pattern deserves to spread.
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