Presented at ACRP 2026 — Orlando, FL

85% time reduction · $78K–$121K saved per trial

Stop losing CRAs to documentation burnout

The average CRA writes 5.4 hours of documentation per monitoring visit — 200+ reports per trial, consistently delivered 8+ days late. It's the leading driver of 30% annual CRA turnover. ICH E6(R3) §5.18.3 demands more rigor, not less. Artha automates the narrative: EDC data in, compliant report out in 40 minutes.

✓ 85% documentation reduction — 5.4 hours to 40 minutes per monitoring visit
✓ ICH E6(R3) §5.18.3 citations auto-generated — no manual cross-referencing, every report audit-ready
✓ Same-day delivery, every visit — eliminate the 8+ day backlog that obscures safety signals

See Sample Report →

ICH E6(R3) §5.18 aligned 21 CFR Part 11 ready SOC 2 compliant AES-256 encrypted

The Problem

CRAs spend more time writing reports than monitoring sites

After every monitoring visit, Clinical Research Associates spend an average of 5.4 hours on documentation — before any actual oversight happens. ICH E6(R3) §5.18.3 requires written monitoring reports for every site visit. The industry average: delivered 8+ days late.

Current Process

5.4 hrs

Average CRA time per report
SCRS Site Landscape Survey · 2023

✕ Manual data transcription from EDC systems
✕ Copy-paste compliance narratives from templates
✕ Reports submitted days or weeks late — delaying safety escalations required under ICH E6(R3) §5.17
✕ Safety signals obscured by a documentation backlog that grows visit over visit
✕ ~30% annual CRA turnover; documentation overload is the leading cited driver (ACRP Workforce Survey)

With Artha

~40 min

10 min compute + 30 min human review

✓ Automated data extraction from EDC
✓ AI-generated compliance narratives
✓ Reports ready same-day, every visit
✓ Real-time safety signal flagging
✓ CRAs focus on oversight, not paperwork

How It Works

Three steps. One complete report.

Artha connects to your existing clinical infrastructure. No workflow disruption, no data migration.

Connect your EDC

Integrates with Medidata Rave, Veeva Vault, Oracle Clinical. Securely pulls visit data, query status, and protocol deviation logs.

One-time setup

Automated compliance checks

Runs SDV, protocol deviation detection, consent tracking, eligibility validation, and SAE verification — automatically.

~10 min compute

Review and approve

Complete monitoring visit report with AI-generated narratives. CRA reviews findings, adds site context, approves.

~30 min review

Automated Compliance

Every check. Every visit. No exceptions.

Comprehensive compliance verification that runs consistently across all monitoring visits — eliminating the variability of manual review.

Source Data Verification

Cross-references CRF entries against source documents. Flags discrepancies with page-level citations.

Protocol Deviation Detection

Scans visit data against protocol parameters. Categorizes deviations by severity and tracks resolution status.

Regulatory Binder Review

Verifies essential document completeness against the ICH E6(R3) §8 checklist (Before/During/After trial). Identifies missing or outdated documents before they become audit findings.

Consent Version Tracking

Confirms subjects signed the current IRB/EC-approved consent. Flags version mismatches and re-consent requirements.

Eligibility Threshold Validation

Validates inclusion/exclusion criteria adherence. Identifies enrollment deviations before they impact data integrity.

SAE Reporting Verification

Cross-checks adverse event timelines against ICH E6(R3) §5.17 reporting windows (7-day expedited for fatal/life-threatening; 15-day for all others). Ensures no SUSAR is missed or late.

Measurable Impact

Quantified results for a mid-size CRO

Based on industry averages for an organization managing 15 active studies with 40+ active sites.

$78K–$121K

Estimated annual savings per active trial

Based on 85% reduction in CRA documentation time (5.4 hrs → 40 min per report), at median CRA fully-loaded cost of $95/hr, across a mid-size CRO managing 15 active studies with 40+ sites.

See a sample report →

85%

Time Reduction

4–8 hours per report reduced to 40 minutes of human review

Late Reports

Same-day report generation eliminates the documentation backlog

Site Coverage

CRAs can monitor more sites without increasing headcount

100%

Audit Coverage

Every check, every visit. No shortcuts under time pressure.

Integrations

Connects to your existing EDC stack

No data migration. No workflow changes. Artha reads from the systems you already use.

Medidata Rave

Electronic Data Capture

Veeva Vault

Clinical Operations

Oracle Clinical

Data Management

+ More

Custom integrations available

Regulatory Alignment

Built for current and emerging guidance

Regulatory frameworks are shifting toward technology-enabled monitoring. Artha is designed to align with this trajectory.

ICH E6(R3) · Nov 2023

Good Clinical Practice — Monitoring Requirements

ICH E6(R3) (Step 4 adoption, November 2023) introduces a proportionate, risk-based monitoring framework. Three sections directly govern monitoring visit reports:

§5.18.3 On-site monitoring — mandates written monitoring reports documenting all findings, deviations, and corrective actions for each visit
§5.18.5 Centralized monitoring — encourages technology-enabled, automated data review as a complement to on-site verification
§8 Essential documents — defines the complete regulatory binder checklist that every monitoring report must verify

Related Guidance

21 CFR §312.62 & WHO TRS 1033

U.S. regulations (21 CFR §312.62) require sponsors to monitor the progress of all clinical investigations they conduct, with written records retained in the Trial Master File. WHO’s TRS No. 1033 Annex 4 (2023 update) reinforces centralized oversight tools and real-time safety signal detection as recommended practice for IND-bearing trials.

Artha generates monitoring visit reports structured to satisfy §5.18.3 documentation requirements, with automated §8 essential-document verification built into every run.