By accessing or using the QuantClinica Electronic Data Capture (EDC) platform, study portals, or related services (collectively, the "Services"), you agree to be bound by these Terms of Service ("Terms") and all applicable laws and regulations.
If you are using the Services on behalf of a sponsor, contract research organization, site, or institution, you represent that you have authority to bind that entity to these Terms. If you do not agree, you must not access or use the Services.
These Terms supplement — and do not replace — your study-specific Master Services Agreements, Data Processing Addenda, and approved protocols.
- Accounts are provisioned only for authorized clinical research personnel and approved study participants. Unauthorized account creation is prohibited.
- You are responsible for safeguarding your credentials. Sharing logins, multi-factor codes, or session tokens is strictly forbidden.
- Notify QuantClinica immediately if you suspect any unauthorized account access or credential compromise.
- Keep your account information accurate and up to date so audit trails remain meaningful.
The Services are licensed, not sold, for legitimate clinical research operations under approved protocols. You agree to use the platform only as described in its documentation and your study assignments.
- Use the Services solely to conduct, monitor, or support authorized clinical studies.
- Operate within the role-based permissions assigned to you. Do not attempt to escalate privileges.
- Respect rate limits, automation policies, and integration scopes documented for sponsors and CROs.
You may not, and may not assist others to:
- Probe, scan, or attempt to penetrate the platform without prior written authorization.
- Tamper with audit trails, electronic signatures, or any control designed to ensure data integrity.
- Reverse engineer, copy, or distribute the Services or any underlying components.
- Use bots, scrapers, or automation to extract data outside of supported integration channels.
- Upload malicious code, attempt to disable safeguards, or interfere with other users' use of the platform.
Violations may result in immediate suspension and reporting to relevant regulatory or law-enforcement authorities.
- All data entered must be accurate, complete, and consistent with source documents and the study protocol.
- Submit data within the timelines defined by your study and respond to queries promptly.
- Use electronic signatures only when you have personally verified the data and intend to authenticate it.
- Comply with ALCOA+ principles — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available.
- Treat all study data, configuration, and platform documentation as confidential.
- Use the Services only on devices that meet your organization's security baseline.
- Follow MFA, session timeout, and password policies enforced by the platform.
- Report suspected security incidents to quantclinica@gmail.com without delay.
The platform is engineered to support compliance with leading clinical research and data-protection regulations. Users must adhere to all applicable institutional, ethical, and regulatory guidelines, including:
- 21 CFR Part 11 — electronic records and electronic signatures.
- ICH GCP E6(R3) — good clinical practice.
- HIPAA & GDPR — patient privacy and data protection.
- Local laws applicable to the country where data subjects reside or where the trial is conducted.
QuantClinica and its licensors retain all rights, title, and interest in the Services, including software, design, trademarks, and supporting materials. No license is granted except as expressly stated in your subscription agreement.
Study sponsors retain ownership of the study data they enter into the platform, subject to the rights granted to QuantClinica to operate, support, secure, and improve the Services.
We strive to maintain high availability of the Services, including a 99.9% uptime objective for production environments. Scheduled maintenance is announced in advance.
Unplanned interruptions, force majeure events, or third-party outages may temporarily limit availability. Critical incidents are handled per the support and SLA terms in your master agreement.
QuantClinica may suspend or terminate access in the event of:
- Suspected unauthorized access, security incident, or compromise.
- Material violation of these Terms or applicable laws.
- Regulatory or legal request directing suspension.
- Non-payment or expiration of the underlying subscription.
On termination, regulated data is preserved or returned per applicable retention obligations and your master agreement.
To the maximum extent permitted by law, QuantClinica is not liable for any indirect, incidental, special, consequential, or punitive damages arising from your use of the Services, including loss of data, revenue, or research outcomes.
Users remain responsible for compliance with all applicable laws, study protocols, and internal SOPs. Direct liability, where permitted, is capped as specified in the applicable master agreement.
These Terms are governed by the laws specified in your master agreement, or, in their absence, the laws of the Republic of India, without regard to conflict-of-law principles. Disputes are subject to the exclusive jurisdiction of the courts of New Delhi, India, unless otherwise agreed.
We may update these Terms periodically. The "Last updated" date at the top of this page reflects the latest revision. Material changes are communicated through in-product notifications or email to administrators.
Continued use of the Services after a change becomes effective constitutes acceptance of the updated Terms.
For questions about these Terms or to report a compliance concern, please reach out:
- General — admin@quantclinica.com
- Security — quantclinica@gmail.com
- Address — Nawada, New Delhi, India