Sets the accountability lens. The same milestone produces different responsibilities across Programming, Biostatistics, Data Management, Regulatory, Clinical, Safety/PV, and Submission Operations/Data Standards.
Navigator
Build a readiness plan around the milestone your team actually has.
Choose the role, target date, deliverable, and generalized context. The Navigator first gives you a live situational brief, then turns the same context into dated actions, handoffs, risks, and evidence checkpoints.
Readiness model
Eight dimensions shape every readiness plan.
Each dimension stays visible so the planning logic is understandable before you generate anything.
Defines the event you are preparing for, such as database lock, dry run, health authority response, startup, submission, safety update, or late change.
Anchors the workflow to real calendar dates so actions become scheduled checkpoints rather than an undated checklist.
Narrows the plan to what is actually being delivered, such as ADaM + TLFs, SDTM, pooled analyses, metadata, figures, or a regulatory response package.
Surfaces the upstream inputs, decisions, transfers, access, reviews, and handoffs that can prevent the work from progressing.
Highlights failure points that can threaten quality, timing, interpretation, reproducibility, or submission readiness.
Defines what proves a checkpoint is truly closed, such as QC records, approvals, reconciliation evidence, logs, or final package references.
Combines the selected context into dated, role-specific actions with collaborators, ownership and handoffs, and evidence expectations.
The information is intentionally visible in every tile. Hover or keyboard-focus adds only a subtle motion cue; no planning detail is hidden behind an interaction.
Ready when you are
Your plan will appear here.
Choose your role, milestone, target date, and deliverable. You can then save the plan to Workspace, copy it, print it, or add the dated actions to your calendar.
Role-specific by design
The milestone backbone is shared. Your responsibilities should not be.
A database lock has common cross-functional gates regardless of role, but the action expected from Programming, Statistics, Data Management, Regulatory, Clinical, Safety/PV, and Submission Operations/Data Standards is different. The Navigator keeps a common milestone backbone while adding a distinct role action and collaborator view to every generated step.
Implementation & reproducibility
Specifications, derivations, code readiness, QC, rerun control, traceability, and technical dependency escalation.
Analysis decisions & interpretation
Estimands, populations, assumptions, statistical interpretation, review priorities, and acceptance of analysis-impacting decisions.
Source-data readiness
Cleaning status, transfer completeness, query closure, external-data reconciliation, and transparent disposition of unresolved data issues.
Submission purpose & package
Authority question, response strategy, delivery expectations, submission components, timing, and consistency of technical content with the regulatory objective.
Clinical context & escalation
Protocol intent, clinically meaningful issues, protocol deviations, prioritization, decision ownership, and cross-functional escalation.
Safety interpretation & reconciliation
Safety cutoff, medically important events, coding/reconciliation, exposure context, aggregate consistency, and escalation of safety-significant changes.
Technical package & regional readiness
Applicable standards, metadata, validation findings, publishing dependencies, package inventory, regional technical requirements, and transfer evidence.
Need context before planning?
Use the Field Guide for the reasoning behind the checkpoint.
Guides cover decisions, failure modes, handoffs, and evidence for twenty-one common clinical data and analysis delivery situations.
Browse the Field Guide →Regulatory pressure?
Start from a realistic submission or authority-response scenario.
See how a compressed request can be translated into a controlled cross-functional response.
View regulatory scenarios →