12 capabilities with end-to-end operational ownership from study startup through submission, inspection readiness, and closeout.
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Business Capability Model
Domain capability map across startup, CTMS operations, TMF, RBQM, data operations, safety, supply, regulatory, vendor, finance, and compliance. 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.
Capability Landscape
Capability tiles are grouped to show operational ownership, control intent, and execution depth.
SSU
Feasibility, country mix, contracting, activation packet
Feasibility triageContract cycle controlsReg/EC startup timeline
CTMS Ops
Monitoring plans, visits, issues, closeout
Visit calendarIssue/deviation handlingCloseout readiness board
TMF
Reference model, filing, QC, inspection packages
Completeness matrixQC backlogInspection bundle compiler
RBQM
CtQ, KRIs/QTIs, central monitoring, evidence
Risk registerKRI alertingCAPA linkage
Data Ops
Reconciliation, query, coding, DBL readiness
Cross-system mappingQuery aging controlsDBL gating checklist
Safety
SAE routing, follow-up, reconciliation, calendar
SAE intake triageFollow-up workflowSafety reconciliation
Supply/IRT
Forecasting, shipments, excursions, IRT oversight
Supply forecastingShipment exceptionsExcursion CAPA
Regulatory/CTIS
Submissions, RFIs, CTIS lifecycle and approvals
Dossier readinessRFI response operationsLifecycle event governance
Vendors
SLA, deliverables, change orders, partitioning
SLA heatmapDeliverable acceptanceAccess partitioning
Finance
Payments, invoices, accruals, spend controls
Milestone releaseInvoice validationAccrual variance review
Training
Assignments, certification, DoA logs
Role training matrixCertification expiryDoA controls
Security
RBAC/ABAC, privacy, model governance
Study firewallingConsent/privacy controlsModel validation registry
Governance controls map across RBAC, ABAC, signatures, evidence traceability, and model validation checkpoints.
Access & Governance Controls
RBAC+ABACStudy Firewall Active
Operational Controls
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.
Next Actions
Filter to portfolio/program/study context.
Open linked tasks, risks, and document evidence.
Escalate blocked items through governed workflow.