Site Platform 

For Research Sites, Investigators & Coordinators 

Terms & Conditions 

Effective Date: April 8, 2026  |  Version 1.0 

HEKMA Clinical Intelligence Platform, Inc.  |  legal@hekma.io 

 

1. Introduction & Acceptance 

These Terms and Conditions (“Agreement”) govern access to and use of the HEKMA Site Platform by research sites, principal investigators (PIs), sub-investigators, clinical research coordinators (CRCs), and other site staff (collectively, “Site Users”). By accessing the Site Platform, you agree to these terms on behalf of yourself and your research organization. 

 

2. Definitions

    • “Site Platform” means the HEKMA web-based dashboard and tools available to research sites for patient pre-screening, study management, regulatory document management, and participant engagement.
    • “Site” means an investigational site, hospital, clinic, or research institution participating in one or more Studies. 
    • “Site User” means any individual authorized by the Site to access the Site Platform, including PIs, sub-investigators, CRCs, and regulatory staff. 
    • “Delegation Log” means the electronic record of task delegation from PI to site staff maintained within the platform. 
    • “TMF” means Trial Master File maintained in accordance with ICH E6(R3) requirements. 
    • “Pre-Screening Module” means HEKMA’s EHR-integrated tool for identifying potentially eligible patients from the Site’s patient population. 

 

3. Account Registration & Role-Based Access 

3.1 Institutional Authorization 

Site access requires execution of a Site Agreement with HEKMA. The PI or authorized institutional representative is responsible for onboarding site staff and managing user permissions through the platform’s RBAC system. 

 

3.2 Individual User Responsibilities 

Each Site User is personally responsible for maintaining the confidentiality of their login credentials. Sharing credentials is strictly prohibited. Users must complete any mandatory HEKMA platform training before accessing clinical trial data. 

 

3.3 Delegation of Authority 

The PI must maintain an accurate and current Delegation of Authority Log within the Site Platform. Tasks may only be assigned to qualified staff in accordance with the log. HEKMA provides an electronic Delegation Log as part of the Site Platform’s regulatory document suite. 

 

4. Permitted & Prohibited Uses 

4.1 Permitted Uses 

    • Reviewing AI TrialMatch pre-screening outputs for your patient population
    • Managing study subject enrollment, screening, and on-study activities 
    • Maintaining electronic Trial Master File (eTMF) documents 
    • Communicating with Sponsors through the platform’s secure messaging system 
    • Entering and reviewing study data as authorized by the applicable protocol 
    • Accessing HEKMA’s Ask HEKMA AI assistant for protocol and regulatory guidance 

4.2 Prohibited Uses 

    • Accessing patient data outside your delegated role or without valid IRB authorization 
    • Using the platform to contact patients for studies for which no valid IRB approval exists 
    • Entering false, fabricated, or falsified research data 
    • Sharing patient-identifiable data outside the platform’s authorized disclosure pathways 
    • Circumventing audit trail functionality required by 21 CFR Part 11 

 

5. Patient Privacy & Regulatory Obligations 

Site Users accessing the HEKMA Site Platform must comply with all applicable regulations, including: 

 

    • FDA 21 CFR Parts 11, 50, 54, 56, and 312
    • ICH E6(R3) Good Clinical Practice
    • HIPAA Privacy and Security Rules (45 CFR Parts 160 and 164)
    • Applicable UAE Federal Health Laws and Dubai Healthcare City Authority regulations where applicable
    • IRB/IEC requirements specific to each Study 

The Site is responsible for obtaining and maintaining valid informed consent from each research participant prior to any study-related activity. HEKMA’s eConsent module is a tool to facilitate this process; responsibility for consent remains with the Site. 

 

6. EHR Integration 

Where the Site Platform is integrated with your Electronic Health Record (EHR) system via FHIR R4 APIs, the following terms apply: 

    • You authorize HEKMA to access only the specific patient data scopes required for pre-screening and eligibility matching, as defined in the Data Use Agreement
    • HEKMA’s access to EHR data is read-only for pre-screening purposes unless otherwise specified
    • You remain responsible for ensuring your EHR data sharing complies with your patients’ consent and applicable HIPAA authorizations 
    • EHR integration data is used solely for the study-specific matching purposes you have authorized 

 

7. Intellectual Property 

Site Users receive a limited, non-transferable license to use the Site Platform solely for the purpose of conducting authorized clinical research activities. All HEKMA platform technology, AI tools, and methodologies remain the exclusive property of HEKMA. 

 

8. Audit Trail & Record-Keeping 

The Site Platform maintains comprehensive audit trails for all data entries, modifications, and access events as required by 21 CFR Part 11. Site Users must not attempt to modify, suppress, or delete audit records. These records may be reviewed by Sponsors, regulatory agencies, or HEKMA’s quality team during audits or inspections. 

 

9. Warranties & Liability 

HEKMA provides the Site Platform as a technology solution to support clinical research activities. HEKMA does not assume the role of Sponsor, investigator, or IRB. The Site retains full clinical, ethical, and regulatory responsibility for conduct of the Study. HEKMA’s liability is limited to direct losses arising from HEKMA’s own negligence or material breach. 

 

10. Term & Termination 

Access to the Site Platform may be terminated by HEKMA in the event of breach of this Agreement, by the Sponsor upon conclusion of a Study, or by the Site upon thirty (30) days’ written notice. Upon termination, the Site must ensure all study records are exported or archived in accordance with applicable regulations before access is revoked. 

 

11. Governing Law 

This Agreement is governed by the laws applicable in the jurisdiction of the Site’s primary location. US sites: Delaware law. UAE sites: applicable UAE federal and emirate-level laws. 

 

12. Contact 

HEKMA Clinical Intelligence Platform, Inc. 

Site Support: sites@hekma.io 

Legal & Compliance: legal@hekma.io 

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