Clinical Products

Clinical Research Platform

One unified eClinical cloud — from first patient in to database lock.

A fully integrated suite covering data capture, trial operations, document management, randomization, safety and analytics. Built GxP-first with 21 CFR Part 11 e-signatures, complete audit trails and IQ/OQ/PQ validation packages out of the box.

21 CFR Part 11 GxP / GCP HIPAA GDPR CDISC (SDTM · ADaM · ODM) ICH E6(R3)

Flagship

Electronic Data Capture (EDC)

The flagship — modern, validated clinical data capture at global scale.

Drag-and-drop CRF & visit-schedule designer with versioned mid-study amendments
Real-time edit checks, auto-queries and configurable review workflows
Role-based blinding, site scoping and study-lock controls

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Clinical Trial Management System (CTMS)

Command center for trial operations, monitoring and milestones.

Study, country and site lifecycle tracking with milestone Gantt views
Monitoring visit planning, trip reports and follow-up item workflows
Enrollment forecasting vs. actuals with predictive alerts

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Electronic Trial Master File (eTMF)

Inspection-ready document management, every day of the trial.

DIA TMF Reference Model taxonomy with sponsor-specific extensions
AI auto-classification and metadata extraction on upload
Completeness and timeliness dashboards by country, site and zone

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ePRO

Patient-reported outcomes captured anywhere, on any device.

BYOD and provisioned device modes with equivalent validated instruments
Visit- and time-driven diary schedules with smart reminders
Multilingual instrument library with linguistic validation tracking

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eCOA

Clinician, observer and performance outcomes — validated end to end.

ClinRO, ObsRO and PerfO instrument support on tablet and web
Rater training, certification and inter-rater reliability tracking
Automated scoring with locked algorithms and audit trails

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RTSM

Randomization and trial supply management without the wait.

Self-service study configuration with validated template library
Block, stratified and dynamic (minimization) randomization
Predictive resupply and drug pooling across protocols

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Randomization Engine

Statistically rigorous randomization as a standalone service.

Permuted block, stratified and covariate-adaptive minimization
Central and site-stratified allocation with audit-proof seeds
Simulation workbench to validate design balance pre-study

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Drug Accountability

Chain of custody for every kit, bottle and dose.

Barcode / QR dispensing with subject and visit verification
Site accountability logs auto-reconciled against RTSM shipments
Returns, destruction and certificate tracking workflows

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Medical Coding

MedDRA and WHODrug coding with AI-assisted autocoding.

MedDRA and WHODrug Global coding with synonym lists
AI autocoding with confidence lanes and human-in-the-loop review
Dictionary upversioning wizard with impact analysis

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Safety Management

Pharmacovigilance case intake to regulatory submission.

Case intake from EDC, email, and structured E2B(R3) feeds
Automated seriousness, expectedness and causality workflows
MedWatch 3500A and CIOMS I form generation

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Clinical Analytics

Live study intelligence for data managers and medical monitors.

Enrollment, screening and completion funnels by site and country
Data quality scores, query aging and SDV progress tracking
Medical monitor views: labs, AEs and patient profiles

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Clinical Reporting

TFLs, patient profiles and submission outputs — generated, not programmed.

TFL specification builder with reusable shells and standards
AI code generation for SAS and R with confidence scoring
Double-programming QC with automated output comparison

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Patient Portal

A consumer-grade experience for trial participants.

eConsent with versioned forms and re-consent workflows
Personal visit calendar with reminders and travel support
Secure messaging with site teams and televisit links

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Site Portal

Everything a research site needs, in one login.

Unified task inbox across EDC, eTMF, CTMS and coding queries
Document exchange with auto-filing into the sponsor eTMF
Training and delegation log management with e-signatures

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Sponsor Portal

Portfolio-level oversight for sponsors and CRO partners.

Portfolio dashboards across studies, programs and regions
Milestone, budget and vendor performance tracking
Blinded / unblinded view segregation with access governance

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How it works

From adoption to advantage in five steps

Design

Model your protocol, visit schedule, CRFs and edit checks with versioned, CDISC-aligned study builders.

Capture

Collect site, patient and vendor data through EDC, ePRO/eCOA and API-driven external loads.

Clean & Review

Automated review rules, query management, SDV and medical coding keep data submission-ready continuously.

Analyze

Real-time dashboards, TFL generation and statistical compute bridges to SAS, R and Python.

Lock & Submit

Snapshot, e-signature sign-off, define.xml and submission package assembly with full traceability.

Built for

Clinical Research Pharmaceuticals Biotechnology Life Sciences Hospitals

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