Terms and Conditions

1. Definitions

For the purposes of these Terms, the following definitions apply:

"Authorized User" means any individual who is authorized by the Customer to access and use the Platform, including but not limited to physicians, clinical research coordinators, principal investigators, sub-investigators, study monitors, clinical research associates, data managers, and regulatory personnel.

"Clinical Trial Data" means all data entered into, generated by, or stored within the Platform in connection with a clinical trial or clinical research activity, including but not limited to electronic case report form (eCRF) data, source medical records, study protocols, adverse event reports, concomitant medication logs, lab results, queries, regulatory documents, trial master file (TMF) and investigator site file (ISF) contents, audit trails, and associated metadata.

"Customer" means the entity (e.g., sponsor, contract research organization, academic institution, or clinical trial site) that has executed an Order Form or Subscription Agreement with Clincove for access to the Platform.

"Derived Data" means any data, datasets, analyses, models, benchmarks, indices, insights, or other works created by Clincove through the aggregation, de-identification, anonymization, statistical analysis, or other processing of Clinical Trial Data and Platform usage data, such that such data does not identify and cannot reasonably be used to identify any individual, patient, Customer, or specific clinical trial.

"Order Form" means the document executed by the Customer and Clincove that specifies the services, scope, fees, subscription term, and other commercial terms applicable to the Customer's use of the Platform.

"Platform" means the Clincove cloud-based software application, including all current and future modules, features, tools, and services provided by Clincove for clinical trial management, data capture, document management, regulatory compliance, and related clinical research operations, together with all APIs, integrations, mobile applications, documentation, and related services.

"Protected Health Information" or "PHI" has the meaning ascribed to it under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its implementing regulations.

"Subscription Term" means the period during which the Customer is authorized to access and use the Platform, as specified in the applicable Order Form.

2. Eligibility and Account Registration

2.1 Eligibility

The Platform is intended for use by licensed healthcare professionals, clinical research professionals, and authorized personnel engaged in the conduct, management, or oversight of clinical trials. By creating an account, you represent and warrant that:

1. You are at least 18 years of age;
2. You have the legal capacity and authority to enter into these Terms;
3. You are acting in a professional capacity on behalf of a Customer that has a valid subscription with Clincove;
4. Your use of the Platform complies with all applicable laws, regulations, and professional licensing requirements in your jurisdiction; and
5. All information you provide during registration is accurate, current, and complete.

2.2 Account Security

You are responsible for maintaining the confidentiality of your account credentials and for all activities that occur under your account. You agree to:

1. Use a strong, unique password and enable multi-factor authentication (MFA) where available;
2. Not share your login credentials with any other person;
3. Notify Clincove immediately at security@clincove.com if you suspect any unauthorized access to or use of your account;
4. Log out of your account at the end of each session, particularly when accessing the Platform from shared devices; and
5. Comply with all applicable organizational security policies and any additional authentication requirements imposed by your Customer.

2.3 Account Provisioning and Role-Based Access

Access to the Platform is provisioned through role-based access controls defined by the Customer's designated administrator. Clincove does not independently verify individual Authorized Users' credentials or professional licenses. The Customer is solely responsible for ensuring that all Authorized Users meet applicable professional and regulatory requirements.

3. Platform Services and Scope

3.1 Services Provided

Subject to these Terms and the applicable Order Form, Clincove grants the Customer a non-exclusive, non-transferable, non-sublicensable right to access and use the Platform during the Subscription Term. The Platform provides an integrated suite of tools and services for clinical trial operations, which may include but is not limited to:

1. Clinical Trial Management: Trial planning, budgeting, site and investigator management, subject enrollment tracking, milestone and visit scheduling, operational reporting, and analytics.
2. Data Capture and Management: Electronic case report form (eCRF) design, clinical data entry and validation, query management, medical coding, data review and lock workflows, and audit trail generation.
3. Document and Records Management: Secure storage of source medical records, trial master file (TMF) management, investigator site file (ISF) management, document version control, role-based access, regulatory document management, and certified-copy functionality.
4. Additional Services: Such other features, modules, tools, and capabilities as Clincove may develop and make available through the Platform from time to time, including but not limited to analytics, reporting, regulatory submission support, safety management, and integrations with third-party systems.

The specific modules and features available to the Customer are determined by the applicable Order Form and subscription tier.

3.2 Service Modifications

Clincove reserves the right to modify, update, or discontinue features of the Platform at any time. For material changes that reduce the functionality available to the Customer under an active Order Form, Clincove will provide at least sixty (60) days' prior written notice. Such notice does not apply to routine maintenance, bug fixes, security patches, or feature enhancements.

3.3 Third-Party Integrations

The Platform may integrate with third-party services (e.g., laboratory information systems, electronic health records, randomization and trial supply management systems). Clincove is not responsible for the availability, accuracy, or performance of third-party services. Use of third-party integrations may be subject to additional terms imposed by the third-party provider.

4. Regulatory Compliance Commitments

4.1 Regulatory Framework

Clincove designs, develops, and operates the Platform in alignment with the following regulatory standards and guidelines. However, ultimate regulatory compliance responsibility for the conduct of any clinical trial rests with the Customer, sponsor, and/or investigator as applicable:

1. HIPAA: Clincove maintains administrative, physical, and technical safeguards for Protected Health Information in accordance with the HIPAA Privacy Rule and Security Rule. A Business Associate Agreement ("BAA") is executed with each Customer as required.
2. GDPR (EU/EEA): The Platform supports compliance with the General Data Protection Regulation (EU) 2016/679, including data subject rights management, lawful basis for processing, data minimization, and cross-border transfer mechanisms. See our Data Processing Agreement for details.
3. ICH GCP E6(R2): The Platform is designed to support compliance with the International Council for Harmonisation Good Clinical Practice guidelines, including audit trail requirements (Section 5.5.3), electronic record integrity, source data verification, and investigator oversight.
4. 21 CFR Part 11 (FDA): The Platform provides controls for electronic records and electronic signatures as required by the U.S. Food and Drug Administration, including audit trails, system validations, access controls, and authority checks.
5. PIPL (China): For clinical trials involving personal information of data subjects in the People's Republic of China, Clincove supports compliance with the Personal Information Protection Law, including data localization requirements, consent management, and cross-border data transfer impact assessments.
6. WHO Annex 7: The Platform supports compliance with the World Health Organization's Technical Report Series guidelines on computerized systems in clinical trials, including system validation, data integrity, and electronic record management.
7. EU Annex 11: The Platform supports compliance with the European Commission's guidelines on computerized systems, including validation, operational controls, and data migration requirements.

4.2 Validation and Qualification

Clincove maintains a validated state for the Platform in accordance with GAMP 5 principles and provides validation documentation packages to Customers upon request, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.

4.3 Audit Trail

The Platform generates and maintains computer-generated, time-stamped audit trails that record the date, time, operator identity, and nature of all data entries, modifications, and deletions. Audit trails are immutable, cannot be deactivated, and are available for regulatory inspection. Audit trail records are retained for the duration required by applicable regulations or as specified in the applicable Order Form.

4.4 Customer Compliance Responsibilities

While Clincove provides tools and infrastructure to support regulatory compliance, the Customer remains solely responsible for:

1. Obtaining and maintaining all required regulatory approvals, including Institutional Review Board (IRB) or Ethics Committee (EC) approvals;
2. Ensuring the clinical trial is conducted in accordance with the approved protocol;
3. Maintaining appropriate informed consent processes;
4. Performing required system validation activities specific to the Customer's use;
5. Training Authorized Users on proper use of the Platform in the context of regulatory requirements; and
6. Conducting any required data privacy impact assessments for clinical trials conducted within their jurisdiction.

5. Data Ownership and Intellectual Property

5.1 Customer Data Ownership

The Customer retains all right, title, and interest in and to all Clinical Trial Data entered into or generated through the Platform. Clincove does not claim any ownership interest in Customer data. Nothing in these Terms transfers ownership of Customer data to Clincove.

5.2 Clincove Intellectual Property

Clincove retains all right, title, and interest in and to the Platform, including all software, algorithms, user interfaces, documentation, trade secrets, trademarks, and other intellectual property. These Terms do not grant the Customer any rights in Clincove's intellectual property except the limited right of access expressly stated herein.

5.3 License to Process Data

The Customer grants Clincove a limited, non-exclusive license to access, process, store, and transmit Customer data solely to the extent necessary to provide the Platform services. This license terminates upon expiration or termination of the Subscription Term, subject to any legally required data retention obligations.

5.4 Derived Data — Ownership, Use, and Commercialization

Clincove shall own all right, title, and interest in and to all Derived Data (as defined in Section 1). The Customer acknowledges and agrees that Clincove may create Derived Data from Clinical Trial Data and Platform usage data, and may use, license, sell, distribute, publish, and otherwise commercially exploit Derived Data without restriction, including but not limited to the following purposes:

1. Product development, improvement, and optimization of the Platform;
2. Creation and sale of industry benchmarking reports, indices, analytics products, and datasets;
3. Research, statistical analysis, and publication of aggregated findings;
4. Training and improvement of machine learning models and algorithms;
5. Marketing, business development, and promotional activities; and
6. Licensing or sale to third parties, including pharmaceutical companies, research institutions, regulatory bodies, and other commercial entities.

All de-identification and anonymization processes shall comply with HIPAA Safe Harbor (45 CFR § 164.514(b)) or Expert Determination (45 CFR § 164.514(a)) methods, GDPR anonymization standards (Recital 26), and any other applicable data protection laws. Clincove shall use commercially reasonable technical and organizational measures to ensure that Derived Data cannot be re-identified. For the avoidance of doubt, Derived Data shall not include any data that identifies or could reasonably be used to identify any individual patient or research subject.

The rights granted in this Section 5.4 shall survive termination or expiration of these Terms and the applicable Order Form. The Customer represents and warrants that it has all necessary authority and consents to permit Clincove's creation and use of Derived Data as described herein.

5.5 Feedback

If the Customer or any Authorized User provides suggestions, enhancement requests, or other feedback regarding the Platform ("Feedback"), Clincove shall be free to use such Feedback without restriction or obligation of any kind. The Customer hereby assigns to Clincove all right, title, and interest in and to any Feedback.

6. Acceptable Use and Restrictions

6.1 Permitted Use

The Platform may only be used for lawful clinical trial management, clinical research operations, and related activities in connection with properly authorized clinical research. All use must comply with applicable laws, regulations, and ethical standards, including informed consent requirements.

6.2 Prohibited Conduct

The Customer and its Authorized Users shall not:

1. Use the Platform for any purpose other than the management, conduct, or oversight of clinical trials;
2. Attempt to reverse engineer, decompile, disassemble, or otherwise derive the source code of the Platform;
3. Sublicense, resell, lease, or otherwise redistribute access to the Platform;
4. Interfere with or disrupt the integrity, security, or performance of the Platform;
5. Upload malicious code, viruses, or any harmful content;
6. Circumvent or attempt to circumvent access controls, audit trails, or security features;
7. Enter knowingly false, fabricated, or fraudulent clinical trial data;
8. Access data or accounts belonging to other Customers without authorization;
9. Use the Platform in a manner that violates the privacy rights of any individual, including patients, research subjects, or investigators;
10. Use automated tools (bots, scrapers, crawlers) to access or extract data from the Platform without Clincove's prior written consent; or
11. Use the Platform in any manner that would cause Clincove to violate applicable law or regulation.

6.3 Suspension for Violation

Clincove reserves the right to immediately suspend any Authorized User's access to the Platform if Clincove reasonably believes such user has violated these Terms, poses a security risk, or is using the Platform in a manner that may result in legal liability for Clincove. Clincove will notify the Customer's designated administrator promptly and work to resolve the issue.

7. Fees, Payment, and Subscription

7.1 Fees

Fees for access to the Platform are as specified in the applicable Order Form. All fees are quoted in U.S. Dollars unless otherwise specified and are exclusive of applicable taxes, duties, and levies.

7.2 Payment Terms

Invoices are due within thirty (30) days of the invoice date unless otherwise specified in the Order Form. Late payments shall accrue interest at the lesser of 1.5% per month or the maximum rate permitted by applicable law. Clincove reserves the right to suspend access to the Platform for accounts with payments overdue by more than fifteen (15) days, upon ten (10) days' prior written notice.

7.3 Subscription Renewal

Unless otherwise specified in the Order Form, subscriptions auto-renew for successive periods equal to the initial Subscription Term unless either party provides written notice of non-renewal at least sixty (60) days prior to the end of the then-current term. Fees for renewal periods may be adjusted with at least ninety (90) days' prior written notice.

7.4 Taxes

The Customer is responsible for all applicable taxes, including sales tax, value-added tax (VAT), goods and services tax (GST), and withholding taxes. If Clincove is required to collect or remit taxes, such taxes will be added to the invoice.

8. Data Security and Incident Response

8.1 Security Measures

Clincove implements and maintains administrative, physical, and technical safeguards designed to protect the confidentiality, integrity, and availability of Clinical Trial Data, including but not limited to:

1. Encryption of data in transit (TLS 1.2 or higher) and at rest (AES-256);
2. Multi-factor authentication (MFA) for all Authorized Users;
3. Role-based access controls with least-privilege principles;
4. Regular vulnerability assessments and penetration testing;
5. Intrusion detection and prevention systems;
6. Continuous security monitoring and logging;
7. Regular backups with encryption and geographic redundancy;
8. Regular independent security assessments; and
9. Employee security awareness training and background checks.

8.2 Incident Response

In the event of a security incident involving unauthorized access to, disclosure of, or loss of Clinical Trial Data, Clincove will:

1. Notify the affected Customer without unreasonable delay and in no event later than seventy-two (72) hours after becoming aware of the incident;
2. Provide a description of the nature of the incident, the data affected, and the measures taken or proposed to address the incident;
3. Cooperate with the Customer's own incident response and notification obligations; and
4. Take reasonable steps to mitigate the effects of the incident and prevent recurrence.

8.3 Customer Security Obligations

The Customer is responsible for implementing appropriate security measures within its own environment, including endpoint security, user training, and compliance with Clincove's recommended security configurations.

9. Confidentiality

9.1 Confidential Information

"Confidential Information" means any non-public information disclosed by either party to the other, whether orally, in writing, or electronically, that is designated as confidential or that the receiving party should reasonably understand to be confidential. Confidential Information includes, but is not limited to, Clinical Trial Data, trade secrets, business plans, technical information, pricing, and security documentation.

9.2 Obligations

Each party agrees to: (a) protect the other party's Confidential Information with at least the same degree of care it uses to protect its own confidential information, but in no event less than reasonable care; (b) use Confidential Information solely for the purposes of fulfilling obligations under these Terms; and (c) not disclose Confidential Information to any third party without the disclosing party's prior written consent, except to employees, contractors, or agents who have a need to know and are bound by confidentiality obligations at least as protective as those herein.

9.3 Exceptions

Confidentiality obligations do not apply to information that: (a) is or becomes publicly available without breach of these Terms; (b) was known to the receiving party before disclosure; (c) is independently developed without use of Confidential Information; or (d) is required to be disclosed by law, regulation, or court order, provided that the disclosing party is given prompt notice (where legally permissible) and the receiving party cooperates with any effort to obtain protective treatment.

10. Warranties and Disclaimers

10.1 Clincove Warranties

Clincove warrants that:

1. The Platform will perform materially in accordance with the applicable documentation during the Subscription Term;
2. Clincove will provide the Platform using commercially reasonable care and skill;
3. Clincove will maintain appropriate security measures as described in Section 8; and
4. Clincove will comply with all applicable laws and regulations in the provision of the Platform.

10.2 Disclaimer

10.3 Customer Warranties

The Customer warrants that: (a) it has all necessary rights, approvals, and consents to submit Clinical Trial Data to the Platform; (b) its use of the Platform will comply with all applicable laws and regulations; and (c) it will not submit data to the Platform that it is not authorized to process.

11. Limitation of Liability

11.1 Cap on Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, CLINCOVE'S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATING TO THESE TERMS SHALL NOT EXCEED THE TOTAL FEES PAID BY THE CUSTOMER TO CLINCOVE DURING THE TWELVE (12) MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO THE CLAIM.

11.2 Exclusion of Consequential Damages

IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, LOSS OF DATA, LOSS OF BUSINESS OPPORTUNITY, OR COSTS OF PROCUREMENT OF SUBSTITUTE SERVICES, REGARDLESS OF THE THEORY OF LIABILITY (CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE), EVEN IF THE PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

11.3 Exceptions

The limitations in Sections 11.1 and 11.2 shall not apply to: (a) a party's breach of its confidentiality obligations; (b) a party's indemnification obligations under Section 12; (c) Clincove's breach of its data security obligations resulting in unauthorized disclosure of PHI; or (d) claims arising from a party's gross negligence or willful misconduct.

12. Indemnification

12.1 Clincove Indemnification

Clincove shall defend, indemnify, and hold harmless the Customer and its officers, directors, employees, and agents from and against any third-party claims, damages, losses, and expenses (including reasonable attorneys' fees) arising from: (a) Clincove's material breach of these Terms; (b) Clincove's negligence or willful misconduct in providing the Platform; or (c) allegations that the Platform infringes the intellectual property rights of a third party.

12.2 Customer Indemnification

The Customer shall defend, indemnify, and hold harmless Clincove and its officers, directors, employees, and agents from and against any third-party claims, damages, losses, and expenses (including reasonable attorneys' fees) arising from: (a) the Customer's breach of these Terms; (b) the Customer's use of the Platform in violation of applicable law; (c) Clinical Trial Data submitted by the Customer or its Authorized Users; or (d) the conduct of any clinical trial managed through the Platform.

13. Term and Termination

13.1 Term

These Terms are effective as of the date the Customer first accesses the Platform or executes an Order Form (whichever is earlier) and continue for the duration of the Subscription Term, unless earlier terminated in accordance with this Section.

13.2 Termination for Cause

Either party may terminate these Terms immediately upon written notice if the other party: (a) materially breaches these Terms and fails to cure such breach within thirty (30) days of receiving written notice of the breach; (b) becomes insolvent, files for bankruptcy, or has a receiver appointed for a substantial part of its assets; or (c) ceases to operate in the ordinary course of business.

13.3 Termination for Regulatory Reasons

Either party may terminate these Terms immediately upon written notice if continued performance would result in a violation of applicable law, regulation, or regulatory guidance, including but not limited to data protection laws, GCP requirements, or export control regulations.

13.4 Effect of Termination

Upon termination or expiration of the Subscription Term:

1. Data Export Period: Clincove will provide the Customer with a period of ninety (90) days to export all Clinical Trial Data in a standard, machine-readable format (e.g., CSV, XML, CDISC-compliant formats). Clincove will provide reasonable assistance with data export upon request.
2. Data Deletion: Following the data export period, Clincove will securely delete or destroy all Customer data within thirty (30) days, unless retention is required by applicable law, regulation, or a valid legal hold. Clincove will provide written certification of deletion upon request.
3. Regulatory Retention: Where Clinical Trial Data must be retained to comply with regulatory requirements (e.g., 21 CFR Part 11, ICH GCP archival requirements), Clincove will retain such data for the period required by applicable regulation at no additional charge to the Customer, in read-only archival mode.
4. Survival: Sections 5 (Data Ownership and IP), 9 (Confidentiality), 10 (Warranties and Disclaimers), 11 (Limitation of Liability), 12 (Indemnification), and 14 (Governing Law) shall survive termination or expiration of these Terms.

14. Governing Law and Dispute Resolution

14.1 Governing Law

These Terms shall be governed by and construed in accordance with the laws of the State of Delaware, United States, without regard to its conflict of laws principles.

14.2 Dispute Resolution

Any dispute arising out of or relating to these Terms shall first be submitted to good-faith mediation. If mediation is unsuccessful within sixty (60) days, either party may submit the dispute to binding arbitration administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules. The arbitration shall be conducted in Wilmington, Delaware before a single arbitrator with expertise in healthcare technology or clinical research. The arbitrator's decision shall be final and binding and may be enforced in any court of competent jurisdiction.

14.3 Injunctive Relief

Notwithstanding the foregoing, either party may seek injunctive or other equitable relief in any court of competent jurisdiction to prevent irreparable harm, including but not limited to breach of confidentiality obligations or misappropriation of intellectual property.

15. General Provisions

15.1 Entire Agreement

These Terms, together with all Order Forms, the Privacy Policy, the Data Processing Agreement, and any applicable Service Level Agreement, constitute the entire agreement between the parties and supersede all prior and contemporaneous agreements, negotiations, and representations relating to the subject matter hereof.

15.2 Amendment

Clincove may update these Terms from time to time. Material changes will be communicated to the Customer's designated administrator via email at least thirty (30) days prior to the effective date of the change. Continued use of the Platform after the effective date constitutes acceptance of the updated Terms. If the Customer does not agree with the changes, the Customer may terminate the subscription in accordance with Section 13.

15.3 Severability

If any provision of these Terms is held to be invalid, illegal, or unenforceable, the remaining provisions shall continue in full force and effect. The invalid provision shall be modified to the minimum extent necessary to make it valid and enforceable while preserving the parties' original intent.

15.4 Waiver

The failure of either party to enforce any right or provision of these Terms shall not constitute a waiver of such right or provision. Any waiver must be in writing and signed by the waiving party.

15.5 Assignment

The Customer may not assign or transfer these Terms without Clincove's prior written consent, except in connection with a merger, acquisition, or sale of substantially all of the Customer's assets. Clincove may assign these Terms without consent, provided that the assignee agrees to be bound by these Terms.

15.6 Force Majeure

Neither party shall be liable for any failure or delay in performance due to causes beyond its reasonable control, including but not limited to natural disasters, pandemics, acts of government, war, terrorism, power outages, telecommunications failures, or third-party service provider failures. The affected party shall provide prompt notice and use reasonable efforts to mitigate the impact.

15.7 Notices

All formal notices under these Terms shall be in writing and delivered to the addresses specified in the applicable Order Form, or to the following:

Clincove, Inc.
Attn: Legal Department
Email: legal@clincove.com
1209 Orange St., Wilmington, DE 19801

15.8 Export Compliance

The Customer agrees to comply with all applicable export control laws and regulations in its use of the Platform. The Customer shall not access or use the Platform from, or export data to, any country subject to comprehensive sanctions by the United States (OFAC), the European Union, or the United Nations without first obtaining all required authorizations.

15.9 No Third-Party Beneficiaries

These Terms do not confer any rights, remedies, or benefits upon any person or entity other than the parties hereto, except that the indemnified parties under Section 12 are intended third-party beneficiaries.

15.10 Relationship of the Parties

The relationship between Clincove and the Customer is that of independent contractors. Nothing in these Terms creates a partnership, joint venture, employment, or agency relationship between the parties.