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Complete CTMS Platform

Empowering
Clinical Research
with CTMS

QuantClinica delivers a comprehensive Clinical Trial Management System (CTMS) that integrates EDC, RTMS, eSource, eCOA, eTMF and eConsent. Streamline clinical trials, ensure data integrity, and accelerate regulatory compliance for a new era of medical discovery. Trusted by pharma and CROs worldwide.

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21 CFR Part 11 ICH GCP Compliant HIPAA Certified GDPR Ready Real-Time Analytics Immutable Audit Trails Electronic Signatures Role-Based Access 21 CFR Part 11 ICH GCP Compliant HIPAA Certified GDPR Ready Real-Time Analytics Immutable Audit Trails Electronic Signatures Role-Based Access
01 About Us

Built for Research, Trusted by Researchers

QuantClinica is at the forefront of clinical research technology, providing a robust and intuitive CTMS platform that accelerates medical discoveries by simplifying data management and ensuring the highest standards of quality and compliance. Our CTMS supports pharma and CROs worldwide from study startup through database lock, integrating EDC, RTMS, eSource, eCOA, eTMF and eConsent.

02+
Years Experience
05+
Trials Managed
99.9%
Uptime SLA

Deep Expertise

Over a decade combining clinical knowledge with cutting-edge software engineering to solve real-world trial challenges.

AI-Driven Insights

Integrating AI analytics and predictive capabilities to empower researchers with actionable, intelligent data.

Security First

Robust encryption, access controls, and full audit trails protect sensitive clinical information at every layer.

Global Reach

Serving clients worldwide from small biotechs to large pharmaceutical corporations facilitating global trials.

02 Core Features  ·  Our Services

Complete CDMS Module Suite

End-to-end digital solutions powering every phase of clinical research — select a module below to explore its toolkit.

A Complete EDC Toolkit

Every tool your clinical trial needs, from initial setup to database lock — all in one powerful, compliant platform.

01

Dynamic eCRF Designer

Build complex electronic Case Report Forms with an intuitive drag-and-drop builder and advanced validation rules.

02

Integrated Query Management

Automate and manage data queries in real-time. Resolve discrepancies faster and ensure cleaner data before lock.

03

Role-Based Access Control

Granular permissions for Sponsors, CROs, Investigators, and Monitors ensuring data is protected at every level.

04

Full Audit Trails

Immutable, time-stamped logs of all data entries, changes, and deletions meeting strict 21 CFR Part 11 requirements.

05

Electronic Signatures

Securely sign off on eCRFs, queries, and study milestones with compliant e-Signatures linked to user identity.

06

Real-Time Analytics

Monitor recruitment, data entry progress, and query status with customizable dashboards for proactive management.

A Complete eTMF Toolkit

Centralize and streamline trial documentation with automated indexing, version control, and inspection-ready TMF management.

01

Centralized Document Repository

A single source of truth for every trial document, filed by DIA TMF Reference Model zones.

02

Automated Indexing & Filing

Auto-classify uploads with metadata extraction and completeness checks against expected document lists.

03

Version Control

Full version history with check-in/check-out, audit-stamped revisions, and supersede tracking.

04

Inspection Readiness

Always audit-ready TMF with completeness dashboards and secure remote access for inspectors.

05

Electronic Signatures

Compliant e-signatures on document approvals and reviews, linked to verified user identity.

06

Archival & Retention

Long-term secure archival with retention policies aligned to FDA, EMA, and ICH GCP requirements.

A Complete eCOA Toolkit

Capture patient-reported outcomes directly with intuitive, configurable instruments for richer and more reliable endpoint data.

01

ePRO Instruments

Patient-reported diaries, questionnaires, and symptom scales delivered on any device.

02

eClinRO & eObsRO

Clinician- and observer-reported assessments with guided workflows and built-in scoring.

03

Bring-Your-Own-Device

Patients use their own smartphones with secure app delivery and offline capture support.

04

Compliance Monitoring

Real-time adherence tracking with smart reminders that drive diary completion rates.

05

Automated Scoring

Instant instrument scoring with endpoint-ready datasets and real-time edit checks.

06

Multilingual Instruments

Validated translations and localization workflows for global multi-country trials.

A Complete eSource Toolkit

Direct data capture at the point of care with seamless EHR integration — reducing transcription errors and site burden.

01

Point-of-Care Capture

Direct data entry at the bedside or clinic, eliminating paper transcription entirely.

02

EHR Integration

HL7/FHIR connectivity pulling source data straight from hospital record systems.

03

Remote Source Verification

Side-by-side source-to-eCRF comparison enabling fast remote SDV for monitors.

04

Device & Wearable Feeds

Direct ingestion from labs, ECG machines, and connected patient devices.

05

ALCOA-C Compliance

Attributable, legible, contemporaneous source records with complete traceability.

06

Offline Capture

Keep capturing at remote sites with secure automatic sync on reconnect.

A Complete eConsent Toolkit

Digitize informed consent with multimedia-rich forms ensuring participant comprehension and regulatory compliance.

01

Multimedia Consent Forms

Video, illustrations, and plain-language content that improve participant comprehension.

02

Comprehension Quizzes

Knowledge checks confirming participant understanding before signature.

03

Remote Consenting

Consent participants from home via secure video plus e-signature workflows.

04

Re-Consent Management

Versioned re-consent on protocol amendments with full tracking of who signed what.

05

Compliant e-Signatures

Identity-verified 21 CFR Part 11 electronic signatures with date and time stamps.

06

Withdrawal Handling

One-click consent withdrawal with automated downstream data flagging.

A Complete Trial Management Toolkit

Study timelines, budgets, site monitoring, randomization, and resource planning in one unified CTMS dashboard.

01

Timelines & Milestones

Plan startup through database lock with Gantt tracking, dependencies, and alerts.

02

Budget & Payments

Site budgets, milestone payments, and grant tracking managed in one ledger.

03

Site Monitoring

Visit scheduling, monitoring reports, and action-item follow-up across all sites.

04

Randomization & Cohorts

Stratified randomization, cohort assignment, and investigational product supply management.

05

Resource Planning

Staff allocation, workload balancing, and enrollment forecasting for every study.

06

Oversight Dashboards

Unified KPI views across sites, recruitment, queries, risks, and study health.

03 Vision & Mandate

Clarity Through Precision

Our vision guides every feature we build and every partnership we forge. QuantClinica is committed to transforming clinical research through data-driven clarity.

Our Vision

To be the world's most trusted and innovative EDC platform accelerating health advancements and making complex data simple and actionable.

Patient-Centric Mandate

Facilitating research that ultimately improves patient outcomes through ethical data handling and efficient trial processes.

Collaboration Mandate

A collaborative ecosystem where sponsors, CROs, sites, and patients can seamlessly interact and contribute to clinical discovery.

04 Tailored Solutions

Built for Every Stakeholder

Specialized solutions designed to meet the unique needs of every player in the clinical research ecosystem.

Pharmaceutical & Biotech

Accelerate drug development with robust data capture, streamlined workflows, and real-time oversight for complex trials.

Contract Research Organizations

Enhance service delivery with efficient, scalable, and compliant EDC tools that simplify multi-study management.

Academic & Investigator Trials

Empower academic researchers and clinical investigators with an easy-to-use, powerful platform for independent studies.

Research Sites & Institutions

Simplify data entry, query resolution, and source data verification reducing administrative burden and improving data quality.

05 Collaborations

Partners in Discovery

We proudly partner with leading organizations across the clinical research ecosystem to deliver integrated and impactful solutions.

Pharmaceutical Companies

Driving innovation and efficiency for global pharma giants in their pursuit of new therapies and treatments.

Contract Research Organizations

Empowering CROs to deliver superior clinical trial management and data services to their clients globally.

Research Institutions

Supporting academic medical centers and universities in groundbreaking investigator-initiated research programs.

Technology Integrations

Seamlessly integrating with LIMS, EHR, eTMF, and analytics platforms to create a unified data landscape.

Regulatory Bodies

Engaging with regulatory authorities to ensure our platform evolves with and supports global compliance standards.

Industry Associations

Active participation in key industry groups to shape the future of clinical data management and best practices.

06 Compliance

Engineered for Regulatory Confidence

Meticulously built to meet and exceed the most rigorous global regulatory standards your trials are always audit-ready.

21 CFR Part 11

Full compliance with FDA regulations for electronic records and electronic signatures, ensuring data integrity and traceability.

ICH GCP

Adheres to Good Clinical Practice standards for ethical and scientific quality in clinical trials worldwide.

HIPAA

Comprehensive Health Insurance Portability and Accountability Act compliance for protecting patient health information.

GDPR

European General Data Protection Regulation compliance ensuring data privacy and security by design.

Data Privacy

Security by design principles embedded throughout the platform to protect sensitive clinical trial data.

Audit Trails

Complete traceability with comprehensive audit trails capturing all system activities and data changes.

EMA & FDA

Regulatory alignment with both European Medicines Agency and Food & Drug Administration requirements.

ISO 27001

International standard for information security management systems ensuring the highest level of data protection.

CDISC Standards

Clinical Data Interchange Standards Consortium compliance for standardized clinical research data exchange.

07 Our Team

The Minds Behind the Platform

A passionate team of clinical research experts, software engineers, and regulatory specialists committed to excellence.

Strategic Leadership

Visionary executives with extensive experience in pharmaceutical R&D, clinical operations, and health tech innovation driving our mission forward.

Engineering & Development

World-class software architects and developers building secure, scalable, and intuitive technology solutions using modern engineering stacks.

Regulatory & Compliance

Experts in global regulatory frameworks FDA, EMA, ICH GCP ensuring our platform remains compliant and audit-ready at all times.

Customer Success

A dedicated team providing comprehensive training, rapid support, and tailored guidance to maximize user success on every trial.

Mr. Ganga Prasad

Mr. Ganga Prasad

Director

30+ years Experience in Business Development & Client Management.

Mr. Abhinay Mishra

Mr. Abhinay Mishra

Designated Partner

4+ year of experience in trial setup, data monitoring and compliance data collection tools designing, handling and management.

Mr. Amit Kumar

Mr. Amit Kumar

Founder & C.e.o

8+ year of experience in trial setup, data monitoring and compliance data collection tools designing, handling and management.

08 Contact

Let's Connect

Have questions or ready to see a demo? Reach out we'll show you exactly how QuantClinica can transform your clinical trials.

admin@quantclinica.com
+91 8076806723 | +91 8368862156
New Delhi, India
Send an Email Request a Demo
09 FAQ

EDC Questions, Answered

Everything sponsors, CROs, and researchers ask about electronic data capture from "what is an EDC system" to choosing the right platform for your trial.

What is an EDC system in clinical trials?

An EDC (Electronic Data Capture) system is software used in clinical trials to collect, manage, and store study data electronically instead of on paper case report forms (CRFs). A modern EDC platform like QuantClinica provides drag-and-drop eCRF design, real-time data validation, integrated query management, complete audit trails, and regulatory compliance with 21 CFR Part 11 and ICH GCP.

What is the best EDC software for clinical trials?

The best EDC software depends on your study size, budget, and compliance requirements. Enterprise platforms such as Medidata Rave and Veeva EDC serve large pharma, while QuantClinica is an AI-powered EDC platform built for small-to-mid pharma, CROs, and academic researchers who need 21 CFR Part 11-compliant electronic data capture, fast study setup, and dedicated support.

How do I choose an EDC platform for my study?

Evaluate each EDC platform against: regulatory compliance (21 CFR Part 11, HIPAA, GDPR), eCRF builder flexibility, query management, audit trails, CDISC/SDTM export readiness, pricing transparency, and support quality. QuantClinica's blog guide "How to Choose an EDC" walks through the full checklist.

Is QuantClinica EDC 21 CFR Part 11 compliant?

Yes. QuantClinica is engineered for 21 CFR Part 11 compliance with electronic signatures, complete audit trails, role-based access control, and validation support. The platform also supports ICH GCP, HIPAA, GDPR, ISO 27001-aligned security, and CDISC standards.

How much does EDC software cost?

EDC pricing varies by vendor, study size, and compliance requirements. QuantClinica offers pricing tailored to your study contact the team for a quote based on your trial's scale and needs.

Does QuantClinica EDC support CDISC standards?

Yes. QuantClinica is built with CDISC-aligned data structures and supports export workflows that prepare clinical data for CDISC SDTM mapping and regulatory submissions to FDA and EMA.

Disclaimer

QuantClinica EDC is intended for authorized clinical research personnel and approved study participants. Users must ensure data accuracy, integrity, and compliance with applicable regulations, including GCP, HIPAA, GDPR, and 21 CFR Part 11. QuantClinica supports data management but does not guarantee clinical outcomes or regulatory approvals. System availability may vary based on maintenance and technical conditions. Use of this platform signifies agreement to all relevant institutional and regulatory requirements.