Sponsor Platform

For Pharmaceutical, Biotech & CRO Partners 

Terms & Conditions 

Effective Date: April 8, 2026  |  Version 1.0 

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


1. Introduction & Acceptance of Terms 

These Terms and Conditions (“Agreement”) govern your access to and use of the HEKMA Clinical Intelligence Platform’s Sponsor-facing portal, dashboard, and associated services (collectively, the “Sponsor Platform”). By registering, accessing, or using the Sponsor Platform, you (“Sponsor”, “you”, “your”) agree to be bound by this Agreement on behalf of yourself and your organization. 

If you do not agree to these terms, you must not access or use the Sponsor Platform. This Agreement is entered into between your organization and HEKMA Clinical Intelligence Platform, Inc. (“HEKMA”, “we”, “us”, “our”). 


2. Definitions 

    • “Sponsor Platform” means the web-based dashboard and associated APIs provided by HEKMA for sponsor organizations to manage clinical trial programs, review AI-matching output, configure eligibility criteria, and access analytics. 

    • “Sponsor” means a pharmaceutical company, biotechnology company, contract research organization (CRO), or authorized delegate accessing the platform for clinical trial management purposes. 

    • “Study” means a clinical trial, observational study, or other research program managed through the Sponsor Platform. 

    • “Site” means an investigational site or research center participating in a Study. 

    • “Patient Data” means de-identified or pseudonymized data about potential or enrolled trial participants, subject to applicable data use agreements and regulatory requirements. 

    • “AI TrialMatch Engine” means HEKMA’s proprietary algorithm that matches patients to clinical trials based on eligibility criteria and health data. 

    • “Health Passport” means HEKMA’s standardized patient health summary format used within the matching workflow. 

3. Platform Access & Authorized Use 

3.1 Account Registration 

To access the Sponsor Platform, your organization must complete HEKMA’s onboarding process, which includes execution of a Master Services Agreement (MSA) or Subscription Agreement, identity verification, and designation of authorized platform administrators. 


3.2 Authorized Users 

You may grant access to the Sponsor Platform only to employees, contractors, or delegates who are bound by confidentiality obligations at least as protective as this Agreement. You are responsible for all actions taken by your authorized users. 


3.3 Permitted Uses 

    • Configuring and managing clinical trial programs and eligibility criteria 

    • Reviewing AI TrialMatch Engine outputs and patient-site match recommendations 

    • Accessing aggregate analytics and site performance dashboards 

    • Communicating with HEKMA-registered research sites through the platform’s messaging system 

    • Downloading permissible reports and data exports as defined in your Subscription Agreement 

    • Managing eConsent workflows and protocol amendments 


3.4 Prohibited Uses 

You must not: 

    • Attempt to re-identify de-identified patient data or circumvent pseudonymization measures 

    • Use the platform to contact patients directly without applicable IRB/IEC approval and patient consent 

    • Reverse-engineer, copy, or replicate HEKMA’s AI algorithms, matching logic, or proprietary methodologies 

    • Share platform credentials with unauthorized third parties 

    • Use the Sponsor Platform for any purpose other than legitimate clinical research 

    • Upload malicious code, automated bots, or unauthorized scripts to the platform 

4. Clinical Trial Management Obligations 

4.1 Regulatory Compliance 

As Sponsor, you remain the regulatory sponsor of record for all Studies managed through the platform. You are solely responsible for: 

    • Compliance with FDA 21 CFR Parts 11, 50, 56, 312, and 314 (US) and applicable UAE regulations 

    • Maintaining valid IND/IDE applications and IRB/IEC approvals for all Studies 

    • Ensuring your Study protocols, consent forms, and eligibility criteria are ethically approved 

    • Compliance with ICH E6(R3) Good Clinical Practice (GCP) guidelines 

    • Compliance with HIPAA, GDPR, and applicable data protection laws 

4.2 Protocol Accuracy 

You are responsible for the accuracy of all protocol information, eligibility criteria, and study parameters entered into the Sponsor Platform. HEKMA’s AI matching is only as accurate as the criteria you provide. HEKMA accepts no liability for matching errors arising from incorrect or incomplete sponsor-supplied criteria. 


4.3 Diversity & Inclusion 

HEKMA supports FDA Diversity Action Plan requirements. Where applicable, Sponsors are encouraged to configure the AI TrialMatch Engine to actively support enrollment of underrepresented populations in line with 21st Century Cures Act provisions. 


5. Data Rights & Intellectual Property 

5.1 Sponsor Data 

You retain ownership of all study protocols, eligibility criteria, and proprietary trial data you submit to the platform. By uploading data, you grant HEKMA a limited, non-exclusive license to process, store, and use that data solely for the purpose of providing the Sponsor Platform services to you. 


5.2 HEKMA Intellectual Property 

All intellectual property in the HEKMA platform, including the AI TrialMatch Engine, Health Passport format, analytics dashboards, software, documentation, and HEKMA’s clinical intelligence methodologies, is owned exclusively by HEKMA. No rights in HEKMA’s IP are transferred to you under this Agreement. 


5.3 Aggregate & De-identified Data 

HEKMA may use de-identified, aggregated, and anonymized data derived from platform activity to improve the AI TrialMatch Engine, generate industry benchmarks, and develop platform features, provided that such use does not identify your organization or any individual. 


6. Confidentiality 

Each party agrees to keep confidential all non-public information of the other party disclosed in connection with this Agreement, and to use such information solely for the purpose of performing its obligations hereunder. Confidentiality obligations survive termination of this Agreement for a period of five (5) years. 


7. Payment & Subscription 

Access to the Sponsor Platform is subject to the fees and payment terms set out in your Subscription Agreement. HEKMA reserves the right to suspend access for non-payment after reasonable notice. All fees are exclusive of applicable taxes. 


8. Warranties & Disclaimers 

8.1 HEKMA Warranties 

HEKMA warrants that the Sponsor Platform will operate materially in accordance with its documentation under normal use, and that HEKMA maintains reasonable information security practices compliant with HIPAA, 21 CFR Part 11, and applicable data protection laws. 


8.2 Disclaimers 

THE SPONSOR PLATFORM IS PROVIDED ON AN “AS IS” BASIS TO THE EXTENT PERMITTED BY LAW. HEKMA DOES NOT WARRANT THAT THE PLATFORM WILL BE UNINTERRUPTED, ERROR-FREE, OR THAT AI-GENERATED MATCH OUTPUTS WILL BE COMPLETE OR ACCURATE. AI MATCHING IS A DECISION-SUPPORT TOOL AND DOES NOT REPLACE CLINICAL JUDGMENT, ETHICS COMMITTEE REVIEW, OR REGULATORY OVERSIGHT. 


9. Liability 

To the maximum extent permitted by applicable law, HEKMA’s total aggregate liability under this Agreement shall not exceed the fees paid by you in the twelve (12) months preceding the claim. HEKMA shall not be liable for indirect, incidental, consequential, or punitive damages. Each party shall indemnify the other against third-party claims arising from its own breach of this Agreement. 


10. Term & Termination 

This Agreement commences on your first access to the Sponsor Platform and continues until terminated. Either party may terminate for material breach upon thirty (30) days’ written notice and failure to cure. Upon termination, your access is revoked and data will be handled per the Data Retention provisions of your Subscription Agreement. 


11. Governing Law & Dispute Resolution 

For US Sponsors: This Agreement is governed by the laws of the State of Delaware, USA. Disputes shall be resolved by binding arbitration in Delaware. 

For UAE Sponsors: This Agreement is additionally governed by applicable UAE Federal Laws and Dubai International Financial Centre (DIFC) regulations where applicable. 


12. Amendments 

HEKMA may update these Terms with thirty (30) days’ written notice. Continued use of the Sponsor Platform following the effective date of any update constitutes acceptance. 


13. Contact 

HEKMA Clinical Intelligence Platform, Inc. 

Legal & Compliance: legal@hekma.io 

Data Protection Officer: dpo@hekma.io 

Support: support@hekma.io

Schedule A Demo