Define which modules, systems, integrations, and metrics are active for this study. Changes are saved automatically.

Systems selected for this study. Use ⚙ Configure to change selection.

Integrations in scope for this study. All routed via enterprise API Hub with GxP audit trail.

Describe the protocol and get a recommended system + integration architecture with rationale, cost, and validation effort — then create a study from it in one click. Existing studies are never modified.

Native interactive dashboards over your live study data — build tiles, slice across them, drill in. No export to external BI required.

Live comparable-trial benchmarks from ClinicalTrials.gov by indication — enrollment, duration, phase mix, common primary endpoints, and active geographies. Use to sanity-check study design against the public landscape.

Indicative roll-up of the selected stack — annual license, validation effort, ongoing FTE, and build timeline. Planning-grade estimates to support build-vs-buy and scope decisions. Click a system for detail.

Side-by-side weighted scoring of up to three clinical systems (EDC, IRT, eTMF, etc.) on regulatory compliance, integration, implementation speed, SLA, DCT-readiness, support, and cost. Indicative scores derived from stated system capabilities — validate against vendor RFP responses before contract award.

Per-system regulatory and validation posture across the selected stack — GAMP category, 21 CFR Part 11 / EU Annex 11 applicability, CDISC alignment, and data-privacy scope. Click a system for detail.

Selected systems shown as a connectivity network. Arrows show integration data-flow direction (source → target); larger ringed nodes are connectivity hubs — potential single points of failure. Click any node for system detail.

When each source system comes under TrialArchitect oversight — connector go-live readiness (in-build → ready → live), plus the implementation schedule below.

Study-specific KPIs derived from protocol endpoints, operational requirements, and system SLAs.

Study-specific KRIs for multi-site perioperative immunotherapy — safety, data integrity, regulatory, and supply chain risks.

Cross-study operational intelligence — system standardisation, KRI coverage, and sponsor oversight

Target vs. actual KPI performance across enrollment · data quality · safety · operations · budget

IND through PDUFA — planned vs actual dates · critical path · phase-grouped timeline

Live KRI scoring, site risk signals, centralized monitoring activities, and monitoring report generation.

Compare systems, integrations, KPIs, and KRIs between any two studies.

Tamper-evident activity log (demonstration) of system actions, data changes, and governance events across all study sites. Not a validated 21 CFR Part 11 record.

Report templates, slide decks, and scheduled reports. Live interactive dashboards now live in Self-Service Analytics.

Enterprise integration architecture — data transfer specifications across 5 tracks. Toggle each spec active/inactive per study, or create a custom spec with ＋ New Transfer.

Guided onboarding to bring data from your existing clinical stack into TrialArchitect — pick a source, test, schedule, and let it flow through the canonical model into reconciliation.

Health, freshness, and error visibility for every inbound data feed — connector status, scheduled loops, and the dead-letter queue with one-click replay.

The clinical data lakehouse — browse every integrated source on one canonical model, join across entities on shared keys, and export. Blinding-aware and fail-closed.

One twin, two modes. Model a strategic decision during the trial or a protocol-design choice before it — then log any scenario to the Calibration Ledger so its projection is measured against the real outcome. Calibration-grade, transparent, non-binding.

Model a decision before you make it. Pull levers — add sites, tighten eligibility, change monitoring intensity, extend follow-up — and see the projected impact on timeline, enrolment, quality, risk, and cost vs. the current baseline, with confidence bands. Calibration-grade what-if, fully transparent.

Predictions, measured against reality. Every committed projection — decision-twin and protocol-design scenarios, remediation impact, enrolment and database-lock forecasts — is recorded with its confidence band, then reconciled against the actual outcome to produce a transparent, inspector-visible accuracy record and a calibration grade. Calibration-grade until a real outcome feed.

Model the protocol before you lock it. Pull design levers — eligibility breadth, visit density, procedures, endpoints, follow-up, planned sites — and see feasibility, enrolment pace, patient burden and cost move vs. your current design, calibrated on your own similar trials. Design out the expensive amendment before it costs you.

Oversight that fixes, not just flags. Turn a reconciliation finding into a governed remediation — proposed, human-attested, executed, then verified by re-reconciliation. Auto-execution is limited to reversible, low-risk, in-app actions; an irreversible source-system write-back is e-signature-gated and connector-gated.

An oversight plane over every AI agent in your trial stack — TrialArchitect’s own agentic layer and third-party agents in integrated systems. Each action is evaluated against autonomy policy, open reconciliation, blinding, and anomaly rules; what matters is flagged for a human. It watches and flags — it never acts on or blocks the agents it observes.

Your turnkey Risk-Based Quality Management program for the now-mandatory ICH E6(R3): a live readiness posture across the 90-item matrix, your risk assessment, KRIs and monitoring plan — with a guided setup and a one-click, priors-informed RBQM plan.

An always-on mock inspection. The copilot walks your reconciled data as the selected inspector persona would, surfaces the likely findings, and drafts a grounded response plus a remediation for each — every draft reviewed and attested by a human before use.

Ingest a system's requirements document, generate test scripts, and (in later phases) let an agentic runner conduct the UAT per role while a human monitors progress and findings. Every artifact is a draft for human review; execution runs in test environments only.

Run an integration data transfer through its connector adapter (fetch → transform → push) and review the transfer report. Adapters default to a synthetic mock until live vendor adapters are configured.

SDTM domains and ADaM datasets this study requires, derived from its selected systems, with a downloadable Define-XML 2.1 specification. Planning specification only — no subject-level data.

Technical inspection-readiness scorecard for the active study — access control, e-signatures, audit integrity, data standards, and validation — scored from the live system posture. Indicative; not a substitute for a qualified assessment.

Governance actions awaiting your electronic signature for the active study, and recently applied signatures. Signing re-authenticates and records a bound, tamper-evident signature.

In-app CCB workflow (SOP-CHG-001): submit a change request → CCB decision (e-signed approve/reject) → mark implemented. Every step is recorded on the tamper-evident audit trail.

Your complete connectivity layer — live health, integration architecture, MCP connectors, and data specifications.

Per-system foundational requirements derived from this study's protocol — EDC, IRT, CTMS, Safety DB, eConsent, Central Lab, eCOA, and TrialArchitect itself. Citation-linked, exportable for vendor handoff, and feeds directly into the UAT plan. AI-assisted draft — for SME and vendor review.

AI-accessible system connections for the TrialArchitect assistant — real-time data access via Model Context Protocol

Weighted compliance scores across audit, signatures, SLA, RBQM, integration reliability, and inspection readiness

FDA/EMA inspection readiness command center — audit completeness, eTMF status, signatures, CAPAs, and regulatory submissions

Traceability, explainability, and compliance audit for all AI-generated recommendations and actions

Upload your protocol document to enable AI-assisted KRI and QTL extraction for your RBQM plan

Per-site IRB/Ethics Committee approval status, expiry dates, annual renewal tracking, and amendment resubmission status — per ICH E6(R3) §3 and 21 CFR §312.66.

Deviation intake, classification, CAPA management, and regulatory reporting

Dispatch specialized AI agents for autonomous clinical operations monitoring — RBQM, safety/PV, data management, regulatory, integration, and clinical ops domains

Context-aware actionable regulatory alerts derived from study configuration, phase, indication, systems, and countries.

Compare study operational metrics against industry percentile ranges. Join the FBN to replace synthetic benchmarks with real cross-sponsor aggregates.

Enrollment forecasting, protocol deviation pattern detection, integration anomaly detection, and industry benchmarking

Real-time operational visibility across systems, integrations, enrollment, and compliance

Role-tailored weekly operational summary — pulled live from study data. Gives CRAs, data managers, medical monitors, and sponsors a grounded reason to open TrialArchitect first each morning.

Aggregated alerts, notifications, and action items from all connected systems — safety signals, data queries, KRI breaches, regulatory deadlines, and integration events

Get AI-assisted answers, report a bug, ask a question, or request a feature. Reports are pre-filled into an email to the TrialArchitect support team, with key diagnostics auto-captured to speed up triage.

Every Help & Support report, stored in-app with the reporter's contact. Triage, resolve, or escalate to a change-capable role.

Manage platform users, roles, and study access. Role and access changes are recorded to the audit trail.

Register, retarget, and retire customer-operated self-hosted TrialArchitect instances — pull mode (agent self-applies) and push mode (TA-initiated, credential-driven). Every action is audit-logged.

Illustrative multi-system event cascades — browser-only simulation, not connected to live system state. Real governed workflows live in Change Control and SOP Library.

A per-subject registry for the active study — enrolment, status, visit schedule adherence, AE/SAE, ePRO and linked deviations.

Per-subject composite risk scoring across visit adherence, AE trajectory, ePRO compliance, deviation history, site tier, and protocol-constraint proximity. Triage before signals become deviations.

Demographic breakdown, DEI KPIs vs. FDA Diversity Action Plan targets, and site-level inclusion performance

Pre-database-lock checklist — query closure, SAE reconciliation, coding, e-signatures, and site-level readiness status

Study entity → FHIR R4 resource mapping, US Core/mCODE profile compliance, and EMR integration readiness assessment

Every regulatory commitment — HA Meeting outcomes, Protocol obligations, and Amendment notification deadlines — tracked against evidence. Inspector-ready KEPT / AT RISK / BROKEN status per commitment.

Amendment version history, subject impact assessment, re-consent triggers, site notification status, and regulatory submission tracking

Live cascade completion across all in-progress amendments — obligations by type, site-by-site readiness matrix, regulatory notification deadlines, and one-click ICH/FDA memo generation.

Stress-test this protocol before first patient enrolled — screen failure rate, amendment probability, enrollment extension, and deviation burden. Calibrated to Tufts CSDD & IQVIA industry benchmarks.

Per-site bottleneck detection across 10 activation milestones · Country-aware HA timeline model for 20 countries · Time-to-first-patient prediction. Benchmark source: TransCelerate Site Activation Metrics · Tufts CSDD 2023.

Per-endpoint probability that FDA will accept primary and key secondary endpoint data — derived from KRI values, visit window compliance, deviation burden, and query status. Regulatory basis: FDA 2022 Endpoint Assessment Guidance · ICH E9(R1) estimands.

Document retention schedules by category and regulatory region — with automated expiry tracking, alert thresholds, and legal hold integration per the DIA Framework for Destruction of Paper v2.0

Suspend normal retention schedules during litigation or regulatory investigation — with dual eSignature authorization, custodian notification, hold scope management, and complete hold lifecycle audit trail

Maps study data against the ICH E6(R3) §8 essential-records typology (Before / During / After Trial) — surfaces gaps in required records as an inspection pre-triage tool

Electronic Content Management System validation status tracking, certified copy attestation workflow, and records destruction authorization — pre-requisites for lawful paper records destruction

Full clinical trial protocol with all ICH M11 / FDA / EMA required fields. Upload a Word or PDF document to auto-populate via AI extraction, or enter fields manually.

Structured benefit-risk evaluation using the BRAT value tree methodology and PrOACT-URL framework — aligned to FDA/EMA regulatory benefit-risk guidance and PFDD meeting outcomes

Patient-Reported Outcome and Clinical Outcome Assessment instruments — validation status, MCID values, ePRO configuration, and FDA/EMA PRO guidance alignment per study protocol

Schema drift detection, missingness anomalies, ingestion latency, and per-connector trust scores — the data quality layer beneath every KRI

Continuous cross-system reconciliation polling — 60-second cadence over connected systems with auto-routing of findings to the assigned Data Custodian by domain

Soft, interim, and final data locks — gate-checked against reconciliation/SDV/query closure, eSignature-attested under 21 CFR Part 11, tamper-evident snapshot captured at commit

Named owners per data domain — reconciliation findings, lock gate failures, and quality alerts auto-route to the assigned custodian with escalation chain

Data Monitoring Committee meetings — member roster with COI tracking, agenda/minutes generation, recommendation capture (continue / modify / pause / stop) with auto-chain into amendments

Generate Data Management Plan, DMC Charter, DMC meeting minutes, and reference the controlling SOP library — all from live study state with eSignature lock

Reference catalog of platform roles, permissions, study scope, and elevation rules. Admin-and-above visibility. CRO Admin sponsor associations are managed here by Super User / Sub-Super User.

Quarterly auto-generated attestation summarising data quality state — reconciliation, locks, DMC oversight, audit evidence. Sponsor-signed under Part 11 eSignature. Public share URL for sites, vendors, and the public.

Sponsor-branded per-site aggregation of every pending action — reconciliation findings, deviations, queries, monitoring visits, CAPAs, training. Delivered through the sponsor's existing site channel; no new site credentials required.

Site-coordinator view of the site's own KRI standing, open action items, upcoming monitoring visit preparation, and training compliance — scoped to a single site. The reciprocal perspective to the sponsor's Site Inbox.

Blinding-safe, participant-scoped trial-health view. Shows trial oversight posture, safety monitoring status, data completeness, SAE reporting timeliness, and consent standing — with no treatment assignment, comparative efficacy, or interim data disclosed.

Detects when your connected systems of record disagree — subject-count, randomised-not-dosed, SAE-without-AE, consent-version drift, consent-after-enrolment, ePRO gaps, overdue-visit-without-data, withdrawn-active drift, duplicate-subject, dispensation-vs-randomisation, and out-of-range-lab-unflagged across EDC · CTMS · IRT · Safety · eConsent · eCOA · Central Lab · Supply Chain

Proves each trust control is enforced — not just claimed. Every control is tested live in your browser against the running app and the real backend, with an honest badge for where it is enforced (DB · API · UI), the live fail-closed result, and the real denial-audit entries. Built for a sponsor security/QA review or an inspector who wants to see the control work, not read that it exists.

A neutral truth layer across your connected systems — confidence-scored discrepancies with root cause, a consistency trend, one-click CAPA, and an inspection-ready ALCOA++ Consistent evidence export.

Standard Operating Procedures lifecycle — authoring, review, approval, and retirement with full version history and Due-for-Review tracking

TA's own regulatory/quality documents (SRS, RTM, VMP, Capabilities Guide, ...) — lifecycle state, e-signature, and file-hash tamper-evidence. Content is still authored externally as the real .docx files; this tracks state, not content.

SOPs shared across every study — created and governed here, visible read-only inside each study's own SOP Library.

Fields, states, and transitions stored as data — the schema behind Change Control, SOP, Training, and Vendor Audit. Read-only; the designer for creating new record types is coming next.

Role × SOP qualification heat-map — completion status, assessment scores, and overdue gap identification for all training-required personnel

Staff qualification compliance dashboard — completion rates by role, overdue assignments, and retraining requirements triggered by SOP updates

Composite QMS health score — SOPs · Training · Vendor Audits · Non-Conformances · Change Control

Quality Management Review — live aggregated QMS KPIs for periodic management review

Formal periodic QMR schedule — scheduled, in-progress, and locked reviews with minutes, findings, and eSignature

IND · CTA · SAE Reports · Amendments — correspondence history, milestone tracking, response deadlines

Per-study intel acknowledged against active filings, plus a curated external FDA · EMA · ICH · MHRA guidance feed ranked by relevance to this study

NDA · BLA · MAA dossier planning — eCTD modules, document assembly checklist, and submission timeline

Health Authority meetings · Q&A log · regulatory commitments and outcome tracking

Cross-linked view — filings · submissions · HA interactions · intelligence · open commitments

GxP vendor qualification, periodic, and for-cause audits with finding management and CAPA linkage

Quality event logging — root cause investigation, disposition, and CAPA linkage for all non-conformances

Corrective and Preventive Actions — auto-drafted from governance signals and KRI breaches, with AI-generated root cause analysis, SLA tracking, and GxP audit trail

Full lifecycle tracking from feasibility through close-out — enrolment progress, risk levels, and investigator details for every site on the active study

Maintain and audit blinding integrity per ICH E6(R3) §5.13.4 and 21 CFR §314.126. Track the randomisation code seal, authorised unblinding personnel, emergency unblinding requests, and the full break log — fail-closed for roles without canViewUnblinded.

Per-line-item budget risk derived from live operational signals — enrollment pace, site risk tier, monitoring overdue, deviation remediation, schedule contingency, and regulatory commitment status. Planning-grade only; supplement with formal budget review for CFO reporting.

A structured Goal Structuring Notation argument that this trial’s data and conduct are trustworthy — each sub-claim bound live to engine-computed evidence. Gaps surface before an inspector finds them.

Every platform “catch” — reconciliation discrepancy, KRI signal, closed CAPA, protocol violation — mapped to a counterfactual DBL-day and indicative cost-avoided figure. The economic twin of the Assurance Case.

Predict → prevent → draft → database-lock impact. The query layer is the largest hidden monitoring cost in a trial — QLI surfaces the forms and sites about to generate the next wave of queries, the targeted prevention action for each, and the DBL-day exposure of the aged backlog.

One composite risk score per site, synthesizing five behavioral drivers — KRI status (30%), investigator engagement (25%), query burden (20%), open deviations (15%) and visit effectiveness (10%). The portfolio heat map ranks every site across every study; the per-site breakdown shows exactly which driver is pushing each site up the curve, so the right lever is obvious before a KRI ever breaches.

Where Site Risk Intelligence scores a site’s risk today, SFR projects where it is heading. Each site gets an enrollment-completion forecast from recent velocity, a database-lock readiness score with the concrete blockers to clear, and a 30/60/90-day SRI trajectory that flags tier breaches before they happen — turning reactive escalation into proactive, scheduled intervention.

For every primary and key-secondary endpoint, ERF projects the share of subjects whose data will be analyzable at database lock — in-window, deviation-free, query-resolved, sample-valid — with a confidence band and the criteria driving any gap. It surfaces endpoints at risk of being non-analyzable months before lock, while there is still time to recover the data.

Real-time ICH E6(R3) compliance status derived from live study data. eSignature-gated quarterly attestation.

Study risk inventory with likelihood × impact scoring, mitigation tracking, and approval workflow.

Per-site SDV strategy, visit frequency by risk tier, and eSignature-gated plan lock.

A controlled document — distinct from the operational Central Monitoring dashboard. Upload an existing plan, generate with AI, then export to PDF or Word.

Per-subject protocol visit completion and window compliance — the visit data that drives KRI and central-monitoring signals.

On-site and remote monitoring visit cadence per site, with overdue tracking.

Remote data review listings, query management, monitoring visit log, and cross-site outlier detection.

Per-site scorecards derived from real enrollment, deviation, KRI, and monitoring visit data.

Model the cost–detection–inspection-risk trade-off for different monitoring strategies. Adjust SDV rate, remote/on-site mix, and visit frequency to see projected outcomes. Planning-grade — use for strategy discussion, not contract pricing.

Forward-looking survival score per site: "Is this site on track to complete the study in good standing?" Five weighted factors — enrollment pace, KRI compliance, deviation burden, visit currency, payment health — surface trajectory risk and prescribe the single highest-impact intervention. INDICATIVE planning-grade. Distinct from Site Risk Intelligence (current-state KRI composite).

One layer above current-state RBQM: probability-of-intervention bands (P30/P60/P90) computed as a logistic function of SRI score and IEI trend velocity, denominated in dollars. The close-vs-remediate cost model answers the question sponsors actually ask — “Is it cheaper to fix this site or replace it?” — and the Intervention Queue routes the answer directly into the agentic attestation workflow. INDICATIVE planning-grade cost figures.

Subject-level analog of the IEI/SRI/PSI stack. Five behavioral factors — ePRO completion, visit window compliance, open query burden, consent version currency, missed assessments — are aggregated into a Subject Engagement Index (SEI) per subject. Logistic models translate composite risk scores into P30/P60/P90 dropout probability bands and deviation probability. Subjects above threshold route to the Intervention Queue for CRA outreach attestation. Indicative planning-grade estimates.

Per-site earned vs released vs outstanding: are payments current, accurate, and within bounds? Detects underpayments, overpayments, and stale holds before they create site disengagement or audit exposure. Indicative planning-grade — supplement with formal CTA reconciliation.

Six-dimension CRO SLA scorecard: visit delivery rate, report turnaround, query resolution speed, deviation acknowledgement, regulatory readiness (on-time filing rate + commitment-ledger health), and communication & responsiveness (% of CRO-owned escalations responded to within severity SLA). Overall posture badge (COMPLIANT / AT RISK / NON-COMPLIANT) with per-dimension evidence and thresholds. Indicative — supplement with formal CRO performance review and SOW milestone tracking.