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Advanced Electronic Data Capture Platform

Empowering
Clinical
Research

QuantClinica delivers intelligent EDC solutions that streamline clinical trials, ensure data integrity, and accelerate regulatory compliance for a new era of medical discovery.

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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

Built for Research,
Trusted by Researchers

QuantClinica is at the forefront of clinical research technology, providing a robust and intuitive EDC platform that accelerates medical discoveries by simplifying data management and ensuring the highest standards of quality and compliance.

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.

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.

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.

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.

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.

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.

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.

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.

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.