Last updated: January 1, 2025
These Terms of Service ("Terms") constitute a legally binding agreement between DoseMind, Inc. ("DoseMind," "we," "our," or "us"), a corporation organized under the laws of the State of Delaware with its principal place of business at 300 Longwood Ave, Boston, MA 02115, and you or the entity you represent ("you" or "Client").
By accessing our website at dosemind.com, by executing an Order Form or Statement of Work referencing these Terms, or by activating and using the DoseMind pharmacokinetic dosing platform (the "Platform"), you agree to be bound by these Terms, our Privacy Policy, and our Cookie Policy. If you are accessing the Platform on behalf of an organization, you represent and warrant that you have authority to bind that organization to these Terms and that your acceptance constitutes acceptance by the organization.
If you do not agree to these Terms, do not access or use the Platform or our website. We reserve the right to modify these Terms at any time. Material changes will be communicated by email or by a prominent notice on our website at least 30 days before the change takes effect for existing subscribers. Your continued use of the Platform after the effective date of any modification constitutes acceptance of the modified Terms.
The DoseMind Platform is a software-as-a-service (SaaS) clinical decision support tool that provides pharmacokinetic modeling, Bayesian maximum a posteriori dose estimation, AUC monitoring, toxicity probability calculations, and regulatory-formatted dose rationale documentation for oncology clinical trials. The Platform is designed for use by credentialed healthcare professionals and clinical research personnel within the context of FDA-regulated clinical investigations.
Clinical Decision Support - Not a Medical Device: The DoseMind Platform provides computational pharmacokinetic analyses and dosing recommendations as decision support information for qualified healthcare professionals. All dosing decisions are the sole responsibility of the treating physician or investigator of record. The Platform does not autonomously administer, prescribe, or dispense any drug. DoseMind's recommendations must be reviewed and approved by the responsible investigator before any dose is prepared or administered.
Regulatory Compliance Scope: The Platform is designed to support compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in the clinical trial context. Responsibility for regulatory compliance with all applicable FDA regulations, ICH guidelines, GCP requirements, and institutional review board requirements remains with the sponsoring institution and the principal investigator. DoseMind provides compliance tools and documentation; it does not assume regulatory sponsor responsibilities.
Access to the Platform is provisioned by DoseMind pursuant to an executed service agreement with a sponsoring institution, pharmaceutical company, contract research organization, or other authorized entity ("Institutional Client"). Individual user accounts are created by the Institutional Client's designated system administrator or by DoseMind on the Institutional Client's request.
Each authorized user must maintain the confidentiality of their account credentials. You are responsible for all activities that occur under your account. You must promptly notify us at hello@dosemind.com if you become aware of any unauthorized use of your account credentials or any other breach of account security. DoseMind will not be liable for any loss or damage resulting from your failure to maintain the security of your account credentials.
Account credentials are personal and may not be shared between multiple individuals. Shared or generic credentials are prohibited and may result in account suspension. Users who change roles, leave the institution, or are no longer associated with an active trial should be deactivated promptly by the system administrator. Institutional Clients are responsible for timely account deactivation procedures as part of their 21 CFR Part 11 access control obligations.
Access to the Platform is provided on a subscription basis as described in the applicable Order Form. Subscription terms, pricing, and payment schedules are set forth in the Order Form or Statement of Work executed between DoseMind and the Institutional Client. All fees are denominated and payable in US dollars (USD).
Payment Terms: Unless otherwise specified in the Order Form, invoices are due and payable within 30 days of the invoice date. Past-due invoices accrue interest at the rate of 1.5% per month (18% per year) or the maximum rate permitted by applicable law, whichever is lower. DoseMind reserves the right to suspend access to the Platform for accounts that are more than 60 days past due after providing 10 days' prior written notice.
Subscription Renewal: Unless the Order Form specifies a fixed term with no automatic renewal, subscriptions renew automatically for successive one-year periods at the then-current subscription rate. Either party may terminate the automatic renewal by providing written notice at least 60 days before the end of the current subscription period.
Price Adjustments: DoseMind may adjust subscription pricing for renewal terms with 90 days' prior written notice. If a price increase exceeds 10% above the prior year's rate, the Institutional Client may terminate the subscription without penalty by providing written notice within 30 days of receiving the price adjustment notice.
Taxes: Subscription fees do not include applicable taxes. You are responsible for all sales taxes, use taxes, and similar charges imposed by any governmental authority on the subscription fees, excluding taxes on DoseMind's income. If DoseMind is required by law to collect taxes on fees charged to you, DoseMind will add such taxes to the applicable invoice.
Refund Policy: Subscription fees paid in advance are non-refundable except as expressly provided in the applicable Order Form or as required by applicable law. In the event of service unavailability due to DoseMind's system failures exceeding the service level commitments specified in the applicable Order Form, pro-rated credits may be applied against future invoices. DoseMind does not provide cash refunds for service credits.
You agree to use the Platform only for its intended purpose as a clinical decision support tool in connection with authorized oncology clinical research activities. You agree that you will not:
DoseMind reserves the right to suspend or terminate access to the Platform for any user or Institutional Client found to be in material violation of these acceptable use provisions after providing notice and a reasonable opportunity to cure where the violation is curable.
Clinical trial data entered into or processed by the Platform by or on behalf of an Institutional Client remains the property of the Institutional Client and the pharmaceutical sponsor as applicable under the applicable clinical trial agreement. DoseMind has no proprietary interest in clinical trial data beyond what is necessary to provide the Services.
You grant DoseMind a limited, non-exclusive license to access, process, and store clinical trial data solely for the purpose of providing the Services to you and maintaining the audit trail and regulatory records required by applicable law. This license terminates upon the expiration or termination of the applicable service agreement, subject to DoseMind's regulatory obligations to retain audit records for the retention periods specified in our Privacy Policy.
DoseMind processes clinical trial data as a data processor on behalf of the Institutional Client, which is the data controller with respect to any personal data of trial subjects processed through the Platform. The terms of such processing are governed by the Data Processing Agreement executed between DoseMind and the Institutional Client.
DoseMind and its licensors own all right, title, and interest in and to the Platform, including all software, pharmacokinetic models, algorithms, user interface design, documentation, and all related intellectual property rights. These Terms do not grant you any ownership rights in the Platform or DoseMind's intellectual property.
The pharmacokinetic population models incorporated in the Platform are proprietary assets of DoseMind. Where population models were derived from or validated against published literature, DoseMind maintains the implementation, validation, and integration of those models as proprietary. Your subscription grants you the right to use the outputs of those models as described herein, not to access, copy, or export the model parameterizations or underlying code.
DoseMind retains ownership of any de-identified, aggregated analytical insights derived from usage patterns across the Platform. We will not use identifiable clinical trial data to develop competing products or for any purpose outside the scope of providing Services to the applicable Institutional Client without explicit written consent.
Each party agrees to keep confidential all non-public information disclosed by the other party in connection with these Terms that is designated as confidential or that reasonably should be understood to be confidential given the nature of the information and the circumstances of disclosure. Each party agrees to use the other party's confidential information only as necessary to perform its obligations or exercise its rights under these Terms, and to protect it using at least the same degree of care it uses to protect its own confidential information, but not less than reasonable care.
The confidentiality obligations above do not apply to information that: (a) is or becomes publicly available through no breach of these Terms; (b) was rightfully known to the receiving party before disclosure without restriction; (c) is independently developed by the receiving party without use of the disclosing party's confidential information; or (d) is required to be disclosed by applicable law, regulation, or court order, provided that the receiving party provides the disclosing party with reasonable prior written notice to permit it to seek a protective order.
Disclaimer of Warranties: THE PLATFORM IS PROVIDED "AS IS" AND "AS AVAILABLE." DOSEMIND MAKES NO WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE PLATFORM, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR THAT THE PLATFORM WILL BE ERROR-FREE OR CONTINUOUSLY AVAILABLE. DOSEMIND DOES NOT WARRANT THAT THE PLATFORM'S DOSE RECOMMENDATIONS WILL PRODUCE ANY PARTICULAR CLINICAL OUTCOME OR THAT THE PLATFORM WILL PREVENT ANY ADVERSE DRUG REACTION OR PATIENT HARM.
Clinical Responsibility: The Platform provides pharmacokinetic modeling outputs and dosing recommendations as clinical decision support information. The treating physician or responsible investigator retains sole medical and legal responsibility for all clinical decisions, including dose selection, administration, and patient monitoring. DoseMind's recommendations do not replace the professional medical judgment of the treating physician.
Limitation of Liability: TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, DOSEMIND'S TOTAL CUMULATIVE LIABILITY TO YOU FOR ALL CLAIMS ARISING OUT OF OR RELATING TO THESE TERMS OR THE PLATFORM, WHETHER IN CONTRACT, TORT, OR OTHERWISE, SHALL NOT EXCEED THE TOTAL FEES PAID BY YOU TO DOSEMIND IN THE 12 MONTHS IMMEDIATELY PRECEDING THE CLAIM. IN NO EVENT SHALL DOSEMIND BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR DAMAGES FOR LOSS OF PROFITS, REVENUE, DATA, GOODWILL, BUSINESS OPPORTUNITY, OR PATIENT OUTCOME, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
You agree to indemnify, defend, and hold harmless DoseMind, its officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, and expenses (including reasonable attorneys' fees) arising out of or in any way connected with: (a) your access to or use of the Platform in violation of these Terms; (b) your or your users' entry of false, unauthorized, or inaccurate data into the Platform; (c) any violation of applicable laws, regulations, or third-party rights by you or your users; or (d) clinical decisions made by treating physicians or investigators using the Platform's recommendations, except to the extent that such claims arise directly from DoseMind's gross negligence or willful misconduct.
These Terms shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to its conflict of laws principles. Any dispute, claim, or controversy arising out of or relating to these Terms or the Platform that cannot be resolved through good-faith negotiation shall be submitted to binding arbitration administered by the American Arbitration Association under its Commercial Arbitration Rules. The arbitration shall be conducted in Boston, Massachusetts. Notwithstanding the foregoing, either party may seek injunctive or other equitable relief in any court of competent jurisdiction to protect intellectual property rights or to prevent irreparable harm.
Either party may terminate the service agreement and these Terms upon the other party's material breach, provided that the non-breaching party has given written notice of the breach and the breaching party has failed to cure such breach within 30 days of receiving such notice (or within 10 business days for breaches involving data security). DoseMind may terminate access immediately and without advance notice in the event of a breach of the acceptable use provisions, unauthorized access to other clients' data, or any action that materially compromises platform security or data integrity.
Upon termination, DoseMind will provide the Institutional Client with a data export in a standard format (JSON or CSV) within 30 days, and will retain data only as required by applicable regulatory retention obligations. The Institutional Client's regulatory obligation to retain clinical trial records continues regardless of the termination of the Platform subscription.
For questions about these Terms of Service, please contact:
DoseMind, Inc.
Attn: Legal Team
300 Longwood Ave, Boston, MA 02115
Email: hello@dosemind.com
Phone: +1 (617) 293-8174