Compliance Standards

Meeting the highest regulatory requirements across every jurisdiction

HIPAA

Health Insurance Portability and Accountability Act compliant

FDA 21 CFR Part 11

Electronic records and signatures compliance

GDPR

General Data Protection Regulation compliant

ICH-GCP E6(R3)

International Council for Harmonisation Good Clinical Practice

WHO GCP (TRS 850)

WHO Guidelines for Good Clinical Practice, Annex 3

Security Features

Built-in protection at every layer

End-to-End Encryption

All data is encrypted in transit using TLS 1.3 and at rest using AES-256 encryption.

Role-Based Access Control

Granular permissions ensure users only access data they are authorized to view.

Audit Trails

Complete visibility into who accessed what data and when, with immutable logs.

Data Backup & Recovery

Automated backups with point-in-time recovery across multiple geographic regions.

Penetration Testing

Regular third-party security assessments and vulnerability scanning.

Multi-Factor Authentication

Enhanced account security with MFA support for all user accounts.

Global Regulatory Frameworks

Clinical trials span borders. Clincove is built to meet the compliance requirements of regulatory authorities worldwide—from ICH member nations to WHO-aligned developing markets.

Aligned with ICH-GCP E6(R3) — the latest international standard finalized January 2025

Americas

United States FDA
21 CFR Part 11

Electronic records and signatures for clinical data integrity

Brazil ANVISA
RDC No. 945/2024

Clinical trial authorization and conduct requirements

Mexico COFEPRIS
Ley General de Salud

General Health Law governing clinical research authorization

Europe & Africa

European Union EMA
EU CTR 536/2014

Clinical Trials Regulation via CTIS portal

South Africa SAHPRA
SA GCP 2020

Locally adapted GCP standards under the Medicines Act

Nigeria NAFDAC
GCP Guidelines 2020

Clinical trial authorization and ICH-GCP compliance

Kenya PPB
CT Guidelines (2nd Ed.)

Pharmacy and Poisons Board clinical trial governance

Asia-Pacific

Japan PMDA
J-GCP / Clinical Trials Act

Ministerial ordinance aligned with ICH-GCP

China NMPA
GCP Order No. 57 (2020)

Updated GCP framework with ethics and registration requirements

India CDSCO
CT Rules 2019

Comprehensive framework with tiered approval timelines

South Korea MFDS
Pharmaceutical Affairs Act

Protocol approval and GCP compliance oversight

Don't see your jurisdiction? Contact us — we're continuously expanding our regulatory coverage.

Standards Alignment

Built to meet international clinical research standards

Standard
Status
Scope
WHO TRS 850 Annex 3
Aligned
WHO Guidelines for Good Clinical Practice
ICH-GCP E6(R3)
Aligned
International Good Clinical Practice Standard

Our Security Process

1

Security by Design

Security is integrated into every phase of our development lifecycle, from planning to deployment.

2

Continuous Monitoring

24/7 security monitoring and automated threat detection protect our infrastructure around the clock.

3

Regular Audits

Independent third-party security assessments and penetration tests are conducted quarterly.

4

Incident Response

Documented incident response procedures ensure rapid containment and resolution of any security events.

99.99%
Uptime SLA
256-bit
Encryption
GDPR
Compliant
24/7
Monitoring

Have Questions?

Have questions about Clincove? We're here to help you find the right solution for your clinical trial needs.

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FDA 21 CFR Part 11
HIPAA & GDPR compliant
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