Trial Formats Features Pricing Calculator About
GCP · ICH E6(R3) · 21 CFR Part 11

Research
is SWEET.

S tudies — every trial design, every phase
W here — urban AIIMS to remote district hospital
E veryone — PI, DEO, CRA, Monitor, Sponsor
E mpowered — AI-assisted capture & smart queries
T echnology — DICOM, OCT, IoT, WHO-DD, offline

The GCP-compliant Electronic Data Capture platform built for the full clinical trial lifecycle — from informed consent to database lock. Online, offline, and AI-powered.

Supported trial formats
RCT Open-label Single-blind Double-blind Crossover Observational Registry Phase I–IV Pilot / Feasibility
GCP
ICH E6(R3) Compliant
app.sucreedc.org · NEURO-PARK-2026
Phase II RCT · Double-blind ● Active
247
Enrolled
94%
Compliance
3
Sites
Open Queries
4 PENDING
Subject 104 · Visit 3 — BP value out of range
Subject 088 · AE Form — CIOMS field incomplete
21 CFR
Part 11 Audit Trail
27+
GCP-ready eCRF templates
12
Role-based access levels
100%
21 CFR Part 11 compliant
9+
Trial formats supported
SUCRE EDC supports all trial formats

Groundbreaking research begins with the right infrastructure

Open-label (Non-blind)
All parties unblinded · Phase III/IV, pragmatic trials
Single-blind
Participant blinded · Investigator unblinded
Double-blind
Participant & investigator blinded · Gold standard RCT
Double-dummy
Active vs active comparator · Crossover designs
Crossover
Within-subject comparisons · Washout management
Parallel Group
Separate arms simultaneously · Multi-site randomisation
Observational / Cohort
Prospective & retrospective · No intervention arm
Registry
Disease registry · Long-term follow-up · CTRI-linked
Pilot / Feasibility
Academic & student research · IRB submissions

All formats fully GCP/ICH E6(R3) compliant · CTRI, ICMR-GCP, and CDSCO regulatory framework support

The SWEET Principle
Every researcher
deserves this.

SUCRE EDC was built around a single conviction — that rigorous, GCP-compliant research should be accessible to every team, at every site, in every condition.

S
Studies
Every clinical study deserves world-class EDC infrastructure — regardless of phase, design, or funding source.
RCTObservationalPhase I–IVRegistryPilot
W
Where
Urban teaching hospital or remote district PHC — SUCRE EDC functions online and offline with automatic sync.
Offline-firstAuto-syncLow-bandwidth
E
Everyone
12 role-based access levels — from PI to DEO, CRA to Medical Monitor — each with precisely scoped permissions.
PIDEOCRAMonitorSponsor
E
Empowered
AI-assisted data entry, smart query generation, PDF OCR for blood reports and prescriptions, patient-facing eDiary.
AI QueriesPDF OCReDiaryPatient Chat
T
Technology
DICOM/OHIF imaging, OCT, OCTA, WHO-DD coded medication, IoT/wearable integration, REST API, e-signatures.
DICOMOCT/OCTAIoTWHO-DDAPI
Core Platform

Everything your trial
team needs — one platform

From enrollment to database lock, SUCRE EDC covers every data workflow with zero regulatory compromise.

Randomisation & Blinding
Central randomisation with stratified block allocation, IVRS/IWRS-ready. Supports open-label, single-blind, double-blind, and double-dummy designs with automated treatment assignment and unblinding audit trail.
eCRF Design & Branching
27+ validated GCP-ready templates across therapeutic areas. Drag-drop form builder with skip logic, field-level validation, conditional branching, and CDash/CDASH-compliant data standards.
Query Management
Full SDV/SDR-compliant query lifecycle — raise, assign, respond, resolve. AI-powered outlier detection auto-raises queries. Complete query audit trail per ICH E6(R3) source data requirements.
DICOM & Imaging
Integrated OHIF/Orthanc DICOM viewer, OCT, OCTA, and multi-modal imaging support. Radiology reads, tumour assessment (RECIST 1.1), and ophthalmology grading within the trial workflow.
AI-Assisted Data Capture
PDF OCR for blood reports, prescriptions, and lab summaries. Auto-population of eCRF fields with audit-flagged AI suggestions. Smart query detection reduces manual error review by up to 70%.
Audit Trail & eSignatures
Comprehensive CAT/SAT per 21 CFR Part 11. Timestamped audit trail for every data entry, modification, and query event. Role-appropriate e-signature workflows for PI review and database lock.
Adverse Event Reporting
CIOMS I & MedWatch-compliant SAE/AE capture. MedDRA and WHO-ART coding, expectedness assessment, causality grading, and automated regulatory notification workflows.
Data Export & Statistics
Clean export to SAS datasets, CSV, Excel, and CDISC SDTM. Built-in descriptive statistics, screening/enrollment logs, and database lock workflow with locked/unlocked audit trail.
IoT & API Integration
REST API for third-party integrations. Connect wearables, glucometers, ECG monitors, spirometers, and smartwatches directly to eCRF. FHIR-compatible data ingestion pipeline.
eCRF Library

27 validated templates
and growing

Every template is GCP-validated, CDash-aligned, and ready for immediate use — or customised for your protocol.

🧠
Neurology
UPDRS · MoCA · NIHSS
❤️
Cardiology
ECG · Vitals · NYHA
🩺
Vital Signs
BP · HR · SpO2 · Temp
⚗️
Haematology
CBC · Differential Count
⚠️
Adverse Events
CIOMS · MedDRA · SAE
💊
Medication / Drug Log
WHO-DD Coded · Concomitant
📊
Quality of Life (QoL)
SF-36 · EQ-5D · WHOQOL
🫁
Pulmonary Function
Spirometry · FEV1 · FVC
🧬
Biospecimen Tracking
Sample · Chain of Custody
👁️
Ophthalmology / OCT
BCVA · IOP · OCT/OCTA
🏥
Tumour Assessment
Oncology · RECIST 1.1
👶
Paediatric Assessments
Growth · Developmental
Patient App

The research experience,
redesigned for patients

A dedicated patient app that connects subjects to their trial — with eDiary, adherence tracking, reminders, and direct IoT device connectivity.

Adherence & Reminders
Push notifications for medication doses, visit reminders, and missed eDiary entries. Automated compliance tracking per protocol.
Patient eDiary & PRO
Validated patient-reported outcomes, symptom diaries, and daily health logs. Multilingual support for pan-India trials.
IoT & Wearable Integration
Connect smartwatches, Bluetooth glucometers, SpO2 monitors, ECG patches, and medical-grade wearables directly to eCRF data.
AI Conversation Interface
Multilingual AI assistant helps patients complete eDiary entries, understand their schedule, and flag adverse symptoms in natural language.
My Trial
● Day 14
Adherence Score
82%
Last 7 days · 3 doses taken
Reminder: Evening dose at 8:00 PM · Tap to confirm
Connected Devices
Apple Watch Glucometer SpO2 Ring BP Monitor
Regulatory Compliance

Built for regulators,
loved by researchers

ICH E6(R3) · GCP
Full ICH GCP compliance including data integrity, audit trail, and source data verification requirements.
21 CFR Part 11
FDA-compliant electronic records, e-signatures, and comprehensive audit trail for all data events.
ICMR-GCP · CDSCO
Indian regulatory framework compliance — ICMR GCP 2017 and CDSCO New Drugs Clinical Trial Rules 2019.
ABDM · Digital Health
Ayushman Bharat Digital Mission ready. ABHA-linked patient records and interoperable health data architecture.
Pricing

Scales with your study size

From single-site pilot studies to global multi-centre trials. All plans include full GCP compliance.

Monthly Annual
Save 20% annually
Starter
$0
Free — up to 30 subjects
Ideal for academic pilots, student research, and single-site feasibility studies.
Up to 30 subjects, 1 site
5 eCRF templates
Basic query management
21 CFR Part 11 audit trail
Email support
Offline data capture
AI features
DICOM imaging
Enterprise / Sponsor
Custom
Tailored to your protocol
For sponsors, CROs, and multi-national trials requiring bespoke infrastructure, SLAs, and regulatory submissions.
Everything in Professional
Bespoke eCRF development
Dedicated server / on-premise
Custom API + EHR integration
Regulatory submission support
24/7 dedicated account team
Study Cost Estimator

How much will your
trial cost on SUCRE EDC?

Estimate your EDC costs based on study design, team size, duration, and required integrations.

Trial Configuration

Fill in your study parameters to get an indicative cost estimate.

Add-on Modules
Estimated Monthly Cost
Configure your study above
Disclaimer: This estimator is provided for indicative purposes only, based on current industry benchmarks. Actual SUCRE EDC pricing may differ based on your specific protocol, regulatory requirements, and negotiated terms. Please submit a registration request or contact [email protected] for a formal quote.
Data Management

Import, export, and
integrate everything

SUCRE EDC is designed for interoperability — import your existing data, export in any format regulators need, integrate with any system.

Export in All Formats
Export your clinical data in CDISC SDTM, SAS XPT, CSV, Excel, PDF, JSON, and XML. Regulatory-submission-ready packages for CDSCO, FDA, and EMA submissions. One-click locked database export.
SDTM · SAS · CSV · Excel · PDF · XML
Import Templates & Data
Import existing eCRF templates from ODM XML, CDASH, or Excel. Migrate historical data from legacy EDC systems (OpenClinica, REDCap, Medidata Rave) via structured import wizards with validation.
ODM · CDASH · REDCap Migration
REST API & Integrations
Full REST API with OpenAPI spec. Integrate with CTMS, eTMF, pharmacovigilance systems, lab systems (LIMS), and EHRs. Webhook support for real-time data events. FHIR R4 compatible.
REST API · FHIR · HL7 · Webhooks
Support & Success

24/7 support built for
clinical research timelines

Clinical trials don't run 9-to-5. Neither does our support. Every SUCRE EDC user gets access to expert help whenever they need it.

24/7 Support
Round-the-clock email, chat, and emergency phone support for active trial sites. Response SLA: <2 hours critical, <6 hours standard.
Support Ticketing
In-app ticketing system with priority classification, SLA tracking, and escalation paths. All tickets tied to study and user context for faster resolution.
Dedicated CSM
Enterprise customers get a dedicated Customer Success Manager — a GCP-trained specialist who knows your protocol and proactively monitors your trial health.
GCP Training Portal
On-demand training modules for DEOs, PIs, and CRCs. Role-specific certification, video walkthroughs, and GCP refresher modules built into the platform.
READY TO SEE SUCRE EDC IN ACTION?

Book a 30-minute demo with our team

Mon–Fri · 9 AM–5 PM IST · Google Meet · With Romario, Lead Product Head

No commitment · Free · Tailored to your trial type

Testimonials

What researchers say

Early feedback from our pilot institutions and academic partners.

★★★★★

"The offline-first architecture was a game changer for our multi-site study running across district hospitals with patchy connectivity. SUCRE EDC just works — everywhere."

AR
Dr. A. Ramaswamy
Principal Investigator · Pilot Partner
★★★★★

"The AI-powered query management reduced our SDV time by nearly 60%. The audit trail is impeccably structured for regulatory submissions — nothing missing, nothing ambiguous."

SN
Dr. S. Nair
Clinical Research Associate · Academic Partner
★★★★★

"We were building our DICOM imaging workflow manually before SUCRE EDC. Having the OHIF viewer natively integrated into the eCRF — with linked query raising — is remarkable."

PK
Dr. P. Kumar
Radiologist · Pilot Institution

Are you an early adopter? We'd love to hear from you.

[email protected]
Research Insights

From the SUCRE EDC
knowledge base

GCP guidance, EDC best practices, regulatory updates, and clinical research methodology — written for trial teams by people who understand GCP.

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