Terms of Use

By accessing or using the AEcelerate platform (the "Service"), you agree to comply with and be bound by these Terms. If you do not agree to these Terms, you must not access or use the Service.

AEcelerate is a software platform designed to assist clinical research teams — including providers, sites, CROs, and pharma sponsors — in running and monitoring clinical trials. It does NOT provide medical advice, diagnosis, or treatment.

• The Service is a support tool for qualified healthcare and research professionals.
• Decisions regarding patient care, safety grading, and adverse event reporting remain the sole responsibility of the investigating physician and research team.
• Always rely on professional medical judgment and established clinical protocols.

AEcelerate is provided as a research platform and is not a licensed medical device, an FDA-cleared Clinical Decision Support tool, or a substitute for formal regulatory submissions or independent professional judgment.

Account Security: You are responsible for maintaining the confidentiality of your credentials. Sharing of accounts is strictly prohibited to ensure audit trail integrity.

Authorized Use: You agree to use the Service only for lawful purposes related to authorized clinical research activities. Authorized users include site staff, CRO personnel, and sponsor teams acting within the scope of their institutional roles. Any unauthorized use of patient data is strictly prohibited.

Data Accuracy: You acknowledge that the output of our automated data processing, evidence linking, and AI-assisted suggestions depends on the quality of data input. You are responsible for verifying all such suggestions before finalizing reports.

Audit Trails: The Service records trace identifiers and per-stage metrics for workflow actions to support accountability and review. You agree not to disable, alter, or circumvent these audit mechanisms.

The Service incorporates AI-assisted features, including third-party generative AI models, to support drafting, summarization, and evidence linking.

• Drafts, not decisions. AI-generated outputs are provided as human-reviewable drafts. They may assist with language, summarization, or explanation, but must not authorize high-risk clinical actions.
• Human-in-the-Loop. No AI-generated output reaches a regulatory submission without explicit clinician sign-off. The investigating physician and research team retain full decisional authority over every clinical determination.
• Verify before reliance. You are responsible for reviewing, validating, and approving all AI-assisted content before it is used in any clinical, regulatory, or operational context.

The AEcelerate platform, including its algorithms, software, design, and trademarks, is the exclusive property of AEcelerate, Inc. and its licensors. You are granted a limited, non-exclusive, non-transferable license to access the Service solely for your internal professional use during the subscription term.

The Service is designed to support alignment with applicable clinical research and AI governance frameworks, including 21 CFR Part 11, ICH E2B(R3), and HIPAA, as well as leading ethical and risk-management references such as the WHO Ethics and Governance of AI for Health, the FDA Clinical Decision Support Software guidance, the EU AI Act, the NIST AI Risk Management Framework, and the AMA Augmented Intelligence in Health Care principles.

References to these frameworks describe AEcelerate's design intent and do not constitute a formal regulatory certification or determination. Ultimate responsibility for regulatory compliance — including submission accuracy, safety reporting, and data integrity — rests with the participating institution, sponsor, or CRO.

You agree to:

• Maintain audit trails and access records consistent with 21 CFR Part 11 requirements.
• Ensure that your use of the Service aligns with your organization's own regulatory obligations and standard operating procedures.

AEcelerate integrates with external systems and data sources, including EHR systems such as Epic (accessed via SMART-on-FHIR / FHIR R4), and regulatory, pharmacological, and scientific sources such as the FDA (including openFDA and DailyMed), ClinicalTrials.gov, PubMed, Semantic Scholar, and OpenScholar.

• The availability, accuracy, and content of these external sources are outside AEcelerate's control.
• You are responsible for verifying data retrieved from or submitted to these third-party sources before relying on it for clinical or regulatory decisions.

To the maximum extent permitted by law, AEcelerate, Inc. shall not be liable for any indirect, incidental, special, or consequential damages, including loss of data or impact on clinical trial timelines, arising out of your use or inability to use the Service. Our liability is limited to the amount paid by you for the Service in the 12 months preceding the claim.

We reserve the right to suspend or terminate your access to the Service immediately, without prior notice, if you breach these Terms, including any unauthorized use of patient data or violation of security protocols.

We may modify these Terms at any time. We will notify users of significant changes via the platform or email. Continued use of the Service after changes constitutes acceptance of the new Terms.

For legal inquiries regarding these Terms, please contact us at:

AEcelerate, Inc.
info@aecelerate.com