Clinical Technology Platform
A unified, 21 CFR Part 11 compliant technology ecosystem purpose-built for modern clinical trials. Our integrated platform delivers seamless data flow, operational visibility, and regulatory compliance from first patient in through regulatory submission.
Ten Platforms. One Ecosystem.
Our technology suite eliminates data silos and streamlines clinical operations through a unified platform architecture with single sign-on, shared data layer, and comprehensive audit trail across all modules.
Electronic Data Capture (EDC)
Our EDC system provides a powerful, intuitive, and fully validated platform for electronic clinical data capture. Designed for multi-site, multi-country trials, it features intelligent form design, real-time data validation, risk-based monitoring support, and comprehensive audit trail functionality to ensure data integrity and regulatory compliance.
Intelligent Form Builder
Drag-and-drop eCRF design with conditional logic, skip patterns, dynamic calculations, and real-time validation rules.
Edit Checks & Queries
Automated edit check firing, query generation, site resolution workflows, and query aging dashboards.
Risk-Based Monitoring
Central monitoring dashboards, KRI tracking, data quality indicators, and site risk scoring for targeted oversight.
Complete Audit Trail
Full 21 CFR Part 11 compliant audit trail with electronic signatures, timestamped changes, and reason codes.
Multi-Language Support
Site-level language selection for global trials with translation management and multi-script character support.
Responsive Design
Device-agnostic interface enabling data entry from desktops, tablets, and mobile devices at point of care.
RTSM / IRT
Our Randomisation and Trial Supply Management system provides robust, validated randomisation capabilities with integrated drug supply forecasting and management. Supporting simple to complex adaptive designs, the platform ensures protocol-compliant treatment allocation while optimising drug supply logistics.
Flexible Randomisation
Block randomisation, stratified randomisation, minimisation, adaptive designs, and re-randomisation support.
Drug Supply Management
Real-time inventory tracking, automated resupply triggers, expiry management, and depot-to-site distribution.
Supply Forecasting
Predictive demand modelling, waste reduction analytics, and scenario planning for optimal supply chain management.
Blinding Management
Robust blinding integrity with controlled unblinding procedures, emergency unblinding, and access-controlled reports.
Multi-Channel Access
Web-based and IVR/IVRS access for site personnel with 24/7 availability and fail-safe redundancy.
EDC Integration
Seamless bi-directional data flow with our EDC platform for automated eligibility verification and visit-driven dispensing.
DocuVault eTMF
DocuVault is our electronic Trial Master File system designed for inspection readiness from day one. Aligned with the DIA TMF Reference Model, it provides automated document filing, comprehensive version control, quality review workflows, and real-time completeness dashboards to ensure your TMF meets regulatory expectations.
TMF Reference Model
Pre-configured folder structure aligned with the DIA TMF Reference Model with customisable zone/section/artefact hierarchy.
Automated Filing
Intelligent document classification, automated metadata tagging, and rule-based filing to reduce manual effort.
Quality Review
Built-in document review workflows, QC checklists, and approval routing with electronic signature support.
Completeness Dashboards
Real-time TMF health metrics, completeness scoring, missing document alerts, and inspection readiness indicators.
Full-Text Search
Advanced search capabilities across all documents with OCR-powered content indexing and metadata filtering.
Regulatory Export
One-click inspection packages, regulatory authority sharing, and archive-ready export in standard formats.
eConsent
Our eConsent platform transforms the informed consent process through digital delivery of consent information with multimedia content, comprehension assessments, and electronic signature capture. Supporting both on-site and remote consent scenarios, it enhances patient understanding while streamlining IRB/EC workflows and ensuring complete regulatory compliance.
Multimedia Content
Rich media delivery including videos, animations, interactive diagrams, and layered information for enhanced patient comprehension.
Comprehension Checks
Configurable knowledge assessments and quizzes to verify patient understanding before consent is captured.
Remote Consent
Secure remote eConsent workflows with identity verification, witness capabilities, and regulatory-compliant electronic signatures.
Version Management
Automated ICF version control, re-consent workflows, and amendment tracking with complete version history.
Multi-Language
Support for multiple languages and locales with translation management for global multi-site trials.
IRB/EC Integration
Streamlined IRB/Ethics Committee approval workflows with document submission and approval tracking.
Clinical Trial Management System (CTMS)
Our CTMS provides comprehensive operational oversight across your entire clinical programme. From site identification through study close-out, manage every aspect of trial operations including site management, milestone tracking, resource planning, financial management, and real-time performance dashboards.
Site Management
Complete site lifecycle management from feasibility and selection through activation, monitoring, and close-out.
Milestone Tracking
Configurable milestone frameworks with automated progress tracking, critical path analysis, and timeline forecasting.
Financial Management
Budget tracking, investigator payment management, change order processing, and financial forecasting dashboards.
Resource Planning
Team allocation, capacity planning, workload distribution, and resource utilisation reporting across studies.
Operational Dashboards
Real-time KPI dashboards, enrolment tracking, country/site performance scorecards, and executive reporting.
Document & Contract
Regulatory document tracking, contract management, essential document collection, and compliance monitoring.
ePRO / eCOA
Our electronic Patient-Reported Outcome and Clinical Outcome Assessment platform enables accurate, real-time capture of patient-reported data directly from participants. Designed for global trials, it supports validated instruments, multi-device access, and compliance-driven workflows to maximise data quality and patient engagement.
Validated Instruments
Support for PRO, ClinRO, ObsRO, and PerfO instruments with validated electronic versions and licensing management.
Multi-Device Access
Responsive design for smartphones, tablets, and web browsers enabling patients to complete assessments anytime, anywhere.
Smart Notifications
Configurable reminders and escalation alerts via push notification, SMS, and email to maximise compliance rates.
Offline Capability
Full offline data capture with automatic synchronisation when connectivity is restored, ensuring no data loss.
Multi-Language Support
Linguistically validated translations with locale-specific formatting for global multi-site clinical trials.
Compliance Dashboards
Real-time patient compliance monitoring, completion rate tracking, and site-level performance analytics.
Remote Source Data Verification (rSDV)
Our rSDV platform strengthens clinical trial oversight by enabling remote access to source documents for data verification without on-site visits. It reduces monitoring costs, accelerates query resolution, and enhances data quality through secure, role-based access to site-level source records.
Remote Source Access
Secure, role-based remote access to source documents enabling CRAs to perform SDV without on-site visits.
Verification Workflows
Structured SDV workflows with configurable verification plans, checklists, and completion tracking per visit and form.
Secure Document Upload
Encrypted document upload with redaction tools, watermarking, and access logging for patient privacy protection.
EDC Integration
Seamless bi-directional linking between EDC data fields and source documents for efficient verification.
Monitoring Dashboards
Real-time SDV progress tracking, site-level completion metrics, and risk-based monitoring indicators.
Cost Reduction
Significantly reduces travel costs and monitoring time while increasing oversight frequency and data quality.
eClinical Analytics
Our eClinical Analytics platform provides a comprehensive business intelligence suite delivering real-time insights across your entire clinical programme. From predictive enrolment modelling to risk-based quality dashboards, make data-driven decisions that accelerate timelines and improve trial outcomes.
Real-Time Dashboards
Interactive, role-based dashboards providing real-time visibility into enrolment, data quality, and operational KPIs.
Predictive Modelling
AI-powered enrolment forecasting, site performance prediction, and timeline simulation for proactive decision-making.
Risk Signals
Automated risk detection with configurable KRIs, statistical quality signals, and site-level risk scoring.
Cross-Platform Data
Unified analytics layer aggregating data from EDC, RTSM, CTMS, ePRO, and other modules for holistic insights.
Automated Reporting
Scheduled report generation, executive summaries, and one-click export in PDF, Excel, and presentation formats.
Configurable KPIs
Custom metric definitions, threshold alerts, and benchmarking against historical programme data.
Clinical Endpoint Adjudication
Our Adjudication platform provides a secure, validated system for independent clinical endpoint adjudication by blinded expert committees. Supporting cardiovascular, oncology, and other therapeutic endpoints, it ensures consistent, unbiased event classification critical for regulatory submissions.
Committee Management
End-to-end management of Clinical Event Committees (CEC) with member onboarding, training tracking, and workload balancing.
Case Dossier Assembly
Automated assembly of adjudication case packages from EDC, source documents, and imaging with de-identification.
Voting & Consensus
Configurable voting workflows supporting independent review, majority rules, and consensus-driven adjudication models.
Blinding Integrity
Robust blinding controls ensuring adjudicators review de-identified, treatment-blinded data throughout the process.
Full Audit Trail
Complete, 21 CFR Part 11 compliant audit trail documenting every decision, vote, and classification change.
Adjudication Analytics
Real-time dashboards tracking event rates, adjudication timelines, inter-rater agreement, and committee performance.
Risk-Based Quality Management (RBQM)
Our RBQM platform enables a proactive, risk-proportionate approach to clinical trial quality management as mandated by ICH E6(R2) and the emerging R3 guidelines. Shift from reactive SDV-heavy oversight to intelligent, centralised monitoring with automated risk signal detection and quality tolerance limits.
KRI Dashboards
Configurable Key Risk Indicator library with automated threshold monitoring, trend analysis, and site-level risk scoring.
Quality Tolerance Limits
Statistical QTL definition, automated breach detection, escalation workflows, and regulatory-ready documentation.
Centralised Monitoring
Cross-site data pattern analysis, statistical signal detection, outlier identification, and data integrity checks.
Risk Assessment
RACT-based protocol risk identification, mitigation strategy planning, and comprehensive risk register management.
CAPA Management
Corrective and preventive action tracking, root cause analysis, effectiveness verification, and audit-ready logs.
Adaptive Monitoring
Risk-driven monitoring visit scheduling, adaptive frequency adjustments, and resource allocation optimisation.
Why Choose Our Technology
Unified Platform
Single sign-on, shared data layer, and seamless integration across all modules eliminates data silos and manual reconciliation.
Validated & Compliant
GAMP 5 validated, 21 CFR Part 11 compliant, GDPR-ready, and SOC 2 Type II audited for the highest security and compliance standards.
Cloud-Native
Hosted on enterprise-grade cloud infrastructure with 99.9% uptime SLA, automated backups, disaster recovery, and global data centres.
Rapid Deployment
Configurable, not custom-coded. Study setup in weeks, not months, with re-usable templates, standards libraries, and automated provisioning.
See Our Platform in Action
Schedule a personalised demonstration to discover how our integrated clinical technology platform can transform your trial operations and accelerate your path to submission.