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eClinical Platform

CRONOS: AI-enabled eClinical Platform for Controlled Study Execution

Purpose-built for BA/BE, early phase, late phase, hybrid, decentralized, and real-world clinical studies. Digitize, control, and accelerate your clinical workflows with a governed AI layer.

Built for real clinical operations — not generic trial management.

CRONOS helps clinical teams digitize and control study workflows across the full trial lifecycle. From volunteer registration and screening to data capture, review, and closeout — CRONOS provides a single, governed eClinical environment.

Designed to support audit trails, role-based access, electronic record controls, review workflows, and validation-ready implementation practices. Suitable for CROs, pharma units, BA/BE centers, academic institutions, and contract research facilities.

5+
Regulatory Audits Supported
80+
Studies Configured
150K+
Patient/Subject Records
10+
Client Organizations
Multi
Country Deployments

Figures based on selected implementation scenarios. Actual results may vary by organization size, study complexity, and deployment configuration.

CRONOS — Study Operations View
👤
Volunteer Registration & Screening
Demographics, eligibility, consent
🎲
Randomization & Dosing
IWRS-controlled assignment
🩸
Sample Collection & Vitals
eSource capture, ECG, lab
📊
Data Review & Query Management
AI-assisted quality checks
Study Closeout & Audit Trail
Controlled archival, evidence lock

Study types CRONOS is designed to support.

⚗️
BA/BE Studies
High-volume volunteer management, sample tracking, randomization, PK collection, protocol deviation tracking, and audit-ready data capture for bioequivalence studies.
🔬
Early Phase Trials
Phase I safety studies with intensive monitoring, dose escalation tracking, adverse event capture, and real-time data review workflows.
📈
Late Phase Trials
Multi-site Phase II/III studies with site data capture, patient-reported outcomes, eConsent, ePRO/eCOA, and distributed workflow management.
🌐
Hybrid / Decentralized
Televisit support, remote patient monitoring, distributed data collection, wearable integrations, and mixed-mode study workflows.
📋
Real-World Evidence
Observational study data capture, follow-up workflows, real-world data collection, registry management, and evidence-linked reporting.
🧪
Consumer & Observational
Consumer health studies, nutraceutical trials, claims studies, observational registries, and structured outcome tracking workflows.

A complete eClinical module set.

📊
EDC
Electronic Data Capture with configurable forms, validation rules, query management, and audit trail.
📋
CTMS
Clinical Trial Management for study setup, site management, milestone tracking, and team coordination.
🩺
eSource
Direct electronic source data capture from clinical site — reducing transcription and improving data quality.
✍️
eConsent
Digital informed consent with multimedia support, subject signature capture, and consent version management.
📱
ePRO / eCOA
Patient and clinician-reported outcome capture via mobile and web with validation and reminder workflows.
🎲
IWRS / RTSM
Interactive Web/Voice Response for randomization, drug supply, kit management, and treatment assignment.
📅
Visit Scheduling
Subject visit planning, reminder management, visit completion tracking, and deviation recording.
Query Management
Automated and manual query generation, response tracking, and resolution workflows for data quality.
📡
Televisit
Remote visit support for decentralized and hybrid trials with structured assessment capture.
📊
Dashboards & Alerts
Real-time study operations visibility with configurable alerts, KPIs, and operational metrics.
🔬
Lab & Device Integration
Structured integration with laboratory systems, ECG devices, wearables, and clinical equipment.
🛡️
Audit Trail
Comprehensive, timestamped audit trail for all data entries, changes, approvals, and access events.

Deep BA/BE workflow fit.

1
Registration & Eligibility
Volunteer registration, screening, inclusion/exclusion, medical history
2
Consent & Randomization
eConsent capture, IWRS-controlled randomization, period assignment
3
Dosing & Sampling
Drug administration recording, PK sample collection, time-point tracking
4
Monitoring & Deviations
Vital signs, ECG, concomitant medication, protocol deviation tracking
5
Data Review & Closeout
AI-assisted quality checks, query resolution, study lock, audit-ready archival

Helping teams identify data quality risks — not replacing expert review.

CRONOS can support AI-assisted review workflows to help teams identify missing values, inconsistent entries, out-of-range values, protocol deviations, and data quality risks for human review and resolution.

All AI-flagged items are presented to qualified clinical data management and medical review teams for expert assessment. CRONOS assists — your team decides.

  • Missing value detection and flagging for human review
  • Out-of-range value identification with clinical context
  • Protocol deviation risk alerts for monitoring teams
  • Cross-form consistency checks and discrepancy alerts
  • Audit trail for every AI flag, human review, and resolution

Designed to support regulated implementation.

CRONOS is designed to support audit trails, role-based access, electronic record controls, review workflows, and validation-ready implementation practices aligned with regulated environments.

Regulatory compliance depends on configuration, customer processes, validation practices, and intended use. CRONOS should be implemented with appropriate customer validation and quality oversight. WHPL can support validation documentation and implementation records as applicable.

  • Designed to support 21 CFR Part 11-aligned workflow controls
  • Role-based access with user authentication and permissions
  • Timestamped audit trail for all data and system events
  • Supports GCP-aware clinical workflow design
  • Validation support documentation available

How CRONOS supports different study environments.

The following are anonymized, illustrative scenarios based on typical use cases in clinical research environments. They are provided for context only.

⚗️
BA/BE Center — High-Volume Study Operations
A contract bioequivalence unit running multiple concurrent studies was managing volunteer data, sample collection timelines, and protocol deviation tracking across paper-based and spreadsheet systems. CRONOS centralized volunteer management, PK sample tracking, and deviation documentation into a single eClinical environment — improving data quality oversight and audit trail completeness across studies.
🏢
CRO — Multi-Site Study Coordination
A contract research organization managing multi-site early phase studies needed better visibility into site-level data quality, query status, and study milestone completion. CRONOS provided a unified operational dashboard — enabling study managers to track site performance, data review status, and query resolution across all sites from a single platform.
📈
Late Phase Study — Distributed Data Capture
A late phase clinical study with multiple geographically distributed sites required structured ePRO collection, eConsent management, and remote monitoring capability alongside centralized data review. CRONOS supported the distributed data capture workflow with structured eCOA, televisit capability, and AI-assisted data quality flagging for the central review team.

CRONOS Aegis AI Agents

AI-native clinical trial intelligence for CROs and sponsors.

CRONOS Aegis is being developed as an AI-powered intelligence and evidence layer for clinical trials. It is designed to help clinical research teams review data faster, detect operational risks earlier, support risk-based monitoring and prepare audit-ready evidence — with human oversight, source traceability and controlled workflows.

Whether your organization uses CRONOS or another EDC, CTMS, DCT, eClinical suite, lab system or eTMF environment, CRONOS Aegis is being designed to connect with existing trial systems and repositories to generate actionable intelligence — without forcing immediate platform replacement.

🔗 CRONOS Native
🔌 Third-Party EDC / CTMS
📁 eTMF & Lab Systems
📄 Docs & Spreadsheets
The problem Aegis addresses
⚠️

Clinical trials are managed across fragmented EDC, CTMS, lab systems, eTMF repositories, spreadsheets and emails — causing delayed risk detection and slow data review.

⚠️

Audit preparation is a manual, high-effort burden. Evidence is scattered. Real-time visibility for sponsors and CRO leadership is limited.

CRONOS Aegis is designed to surface operational and clinical risk intelligence across these fragmented systems — with human review at every decision point.

Three AI agents. One intelligence layer.

🔍
Agent 01

AI Data Review Agent

Designed to detect data inconsistencies, missing forms, abnormal values, outliers and potential query candidates across clinical trial data — surfacing AI-identified risks for qualified data management and medical review teams to assess and resolve.

  • Missing form and field detection
  • Outlier and abnormal value flagging
  • Cross-dataset consistency checks
  • AI-surfaced query candidates for human review
📡
Agent 02

AI Monitoring Agent

Designed to prioritize sites, subjects, visits, deviations and monitoring focus areas based on operational and clinical risk indicators — supporting risk-based monitoring decisions for clinical operations and monitoring teams without replacing monitor expertise.

  • Site and subject risk prioritization
  • Deviation pattern detection
  • Monitoring focus area recommendations
  • RBM signal support for clinical teams
🛡️
Agent 03

AI QA & Evidence Agent

Designed to identify missing documents, SOP and protocol gaps, evidence gaps and inspection-readiness risks across trial documentation and quality workflows — providing structured intelligence for QA and audit-readiness teams to act on.

  • Document and evidence gap detection
  • SOP and protocol alignment checks
  • Inspection-readiness risk flagging
  • Audit-ready evidence organization support
🔐

Built for regulated clinical research environments. CRONOS Aegis is designed with human approval gates, role-based access control, source traceability, immutable audit trails and validation-ready workflows. AI agents surface intelligence — qualified clinical, data management, monitoring and QA teams retain full decision authority.

Design Partner Program

Join the CRONOS Aegis Design Partner Program

We are inviting selected CROs, pharma companies and clinical research teams to participate in our early design-partner program — shaping the agent capabilities, integration model and workflow design of CRONOS Aegis.

Talk to Webo Healthtech Explore Aegis in Detail

See CRONOS in your clinical workflow.

Book a workflow-specific demo for BA/BE, early phase, hybrid, or late phase study execution.