Swimlane execution maps for study launch, hybrid monitoring, CTIS lifecycle, inspection readiness, and CSR production. This workspace exists to enforce consistent clinical execution with accountable ownership, governed evidence, and inspection-ready traceability across the study lifecycle. It supports business and regulatory requirements by connecting operations, quality, submissions, and financial controls in a single system where handoffs are explicit and auditable. Users can proceed by filtering scope, reviewing linked artifacts and actions, and routing escalations with defined approval gates and signature meaning.
Tile-based swimlanes covering startup, operations, quality, data, regulatory, finance, and inspection scenarios.
Take approved protocol concept through country strategy and first activated sites with full evidence traceability.
Input: protocol concept, country strategy | Output: activated sites + startup evidence trail
Combine visit execution and central monitoring into one closed-loop risk governance cycle.
Input: KRIs/QTIs + visit findings | Output: signed actions + CAPA evidence
Control Part I/II dossier readiness and RFI response progression with approval gates.
Input: Part I/II artifacts | Output: approved responses + lifecycle audit
Detect readiness gaps and compile a regulator-facing package under time pressure.
Input: TMF completeness + actions | Output: inspection package + audit event
Resolve EDC/IRT/Lab/eCOA mismatches with deterministic root-cause and closure routing.
Input: cross-system case queue | Output: resolved discrepancies + trail
Route SAE intake through follow-up and reconciliation with strict due-date controls.
Input: SAE reports + source docs | Output: reconciled case pack
Manage shipment and temperature excursion events with corrective action linkage.
Input: IRT + depot telemetry | Output: disposition + CAPA evidence
Connect SLA-tracked deliverables with acceptance checks and finance release decisions.
Input: deliverable package + invoice | Output: approved payment milestone
Keep role-based training and delegation records current before role-critical activity.
Input: role requirements | Output: compliant access + signed DoA linkage
Move from DBL to draft-ready CSR sections with citation and review governance.
Input: locked datasets + SAP | Output: citation-backed CSR sections
Detect connector failures early and drive controlled recovery with reconciliation checks.
Input: event stream failures | Output: recovered pipelines + validated sync
Execute final closeout tasks and archive package with complete evidence controls.
Input: site closeout records | Output: archive-ready package + final sign-off
Roll out a consent version update and ensure reconsent completion by impacted subjects.
Input: updated consent language | Output: complete reconsent trail
Convert inspection findings into corrective plans and verify sustainable closure.
Input: inspection observations | Output: closed findings with effectiveness evidence
Study firewalling chips highlight boundary, country constraints, and vendor partition rules.
Actions requiring GxP control include a human review checkpoint and e-signature meaning capture.
Every state change writes immutable audit evidence with actor, timestamp, and object reference.
Filter to portfolio/program/study context.
Open linked tasks, risks, and document evidence.
Escalate blocked items through governed workflow.