Online Service Terms & Conditions

Version
3
- published on
March 6, 2022

Our Online Service Terms & Conditions (hereinafter “Agreement”) is a contract that governs our customers’ use, subscription and purchase of SMART-TRIAL’s services. This contract applies between us (hereinafter “SMART-TRIAL”) and you (hereinafter “Customer”). This Agreement applies unless it is superseded by a written agreement.

1.0 DEFINITIONS

This document uses the following definitions:

  • “SMART-TRIAL”, “Licensor”, “Publisher”, “we”, “us”, or “our” means the applicable contracting entity, SMART-TRIAL ApS, CVR no. DK35139710, K. Christensens Vej 2L, 9200 Aalborg SV Denmark and its Affiliates.
  • “Customer”, “Licensee”, “Subscriber”, “You”, or “your” means the person or entity using the Subscription Services, or receiving the service purchased, identified in the account record, billing statement, online subscription process, quote or Subscription Services.
  • “Agreement” or "T&C”, the Online Service Terms and Conditions contract that governs the subscription, licensing, use, purchase of any services provided by us.
  • “Affiliate” or “Affiliates”, means any entity/ies which is owned or controlled by or is under common ownership or control with Subscriber at the time of execution of this agreement or at any time during the currency of this agreement. The term "control" as used in the preceding sentence means, with respect to a corporation, the right to exercise, directly or indirectly, more than 50% of the voting rights attributable to the shares of the controlled corporation and, with respect to any person other than a corporation, the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such person.
  • "Billing Period” means the period for which you agree to prepay fees for services depicted in a Quote. This may be the same length as the Subscription Period specified in the Quote, or it may be shorter. For example, if you subscribe to the Subscription Service for a one (1) year Subscription Period, with a twelve (12) month upfront payment, the Billing Period will be twelve (12) months.
  • “Customer Data”, the data which we collect about you and your behavior within SMART-TRIAL, including but not limited to study performance data, study format, etc.
  • ”Data”, the data and information generated and/or entered by you, your users, or your Study Subjects in SMART-TRIAL. This might include personal data and depends on your use of our Subscription Services.
  • “GDPR”, The Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
  • “Quote” or “License Quote” or “Subscription & Services Quote”, means the SMART-TRIAL approved form, or another form of approved order and/or purchase request from us, by which you agree to subscribe to the Subscription service and/or purchase services from us.
  • “Subscription Services” all the web-based applications, software, tools, platforms, content, and other related services that you have agreed to subscribe to in a Quote covered by the Agreement, for which you pay a fee or for which a fee is waived.
  • “Services” all non-web-based services that you have agreed to purchase in a Quote covered by the Agreement, for which you pay a fee or for which a fee is waived.
  • “The Subscription” or “License”, your rights to use our Subscription Services or Services, which is achieved by accepting this Agreement.
  • “Subscription fee” or “fee” or “license fee”, means the amount you pay for the subscription services or service requested by you.
  • “Subscription Period” or “License Period”, The time period for which the Subscription is granted to you.
  • "Study Storage Size”, the total size in gigabytes (GB) of all data contained within a SMART-TRIAL Service.
  • “Users”, anyone who has access to SMART-TRIAL governed by the Agreement, including employees, consultants, investigators, site users, students, and other users.

2.0 QUOTES, PURCHASE ORDERS, AND ORDER CONFIRMATIONS

2.1 You may accept a Quote from us which specifies the services requested by you and details the Subscription Services, and other Services, along with fees and cost related to such services.

2.2 Quotes can be in the form of a quote document from us, an accepted and confirmed purchase order from you, or other kind of order confirmations from us in writing, for example via email.

2.3 A Quote from us is valid for 14 days from the date of issue unless otherwise stated. Acceptance of a Quote received by us after the validity expiry date is not considered binding unless it is confirmed in writing by us.

2.4 You cannot modify a Subscription Quote from us, without our written consent

3.0 SUPPORT AND SERVICE LEVEL

3.1 You and your Users are entitled to technical support from us during standard service hours between 09:00 and 17:00 o’clock Monday through Friday (CET).

3.2 Support is only given in relation to usage of the SMART-TRIAL product and services and not in relation to any of you or your user’s computer equipment, browsers, applications, etc.

3.3 Support inquiries shall be requested by emailing SMART-TRIAL customer support directly via help@smart-trial.com.  

3.4 You are entitled to technical support for all of your study/project staff/users using SMART-TRIAL, including Sponsor, clinical monitors, and all site(s) staff/users (investigators etc.) – but not any study patients/subjects

3.5 SMART-TRIAL service level, quality assurance, uptime, backup, and other failover procedures are provided according to the SMART-TRIAL Security & Service Level Statement.

4.0 SUBSCRIPTION SCOPE

4.1 Usage of Subscription Services

4.1.1 Upon acceptance of a quote, you (and your Affiliates, if any) achieve a limited and non-exclusive right to use SMART-TRIAL features, services, and eventual selected add-ons in accordance with the Quote and this Agreement. You are also entitled to receive any subsequent system updates to these features and any eventual selected add-ons, in accordance with the Agreement for the duration of the subscription.

4.1.2 The rights of use solely grant you to use the Subscription Services in relation to normal usage of the SMART-TRIAL platform, when structuring and planning data-collection projects, as well as to collect, store, and export data on people/ patients/ trial-subjects. The Subscription Services can be used for your collection of personal data, including sensitive personal data, which entails that we process personal data on behalf of you (or your Data Controller). The Standard Contractual Clauses (data processor agreement) in Appendix 1 apply to such processing of personal data on your behalf. If you are an entity established outside the EU/EEA in a country which is not approved by the EU Commission as a non-European country offering an adequate level of data protection in accordance with GDPR article 45, the Standard Contractual Clauses in Appendix 2 apply to the transfer of personal data from us to you.

4.1.3 The content of Appendix 1 and 2 reflect the standard configuration of the Subscription Services. You acknowledge that you are solely responsible for any derogations from the standard configuration which affect the processing of personal data through the Subscription Services, including, but not limited to, any insufficiencies in Appendix 1 or Appendix 2 resulting from your derogation from the standard configuration.

4.1.4 You acknowledge that if you act as a data controller in relation to your use of the Subscription Services you have the sole responsibility for complying with your obligation to inform data subjects subject to your processing of personal data via SMART-TRIAL of the processing in accordance with Article 13 and 14 of the GDPR, and seeking relevant consents for participation in clinical investigations/ trials, for subjects/patients, users, and other affected data subjects.

4.1.5 You may not grant access to Subscription Services or other SMART-TRIAL’s Intellectual Property (as defined in section 7.0 below) to any third parties that compete with us. Third parties that develop software platforms for collection of data in clinical studies or clinical investigations are considered competitors in this regard.

4.1.6 Subscription Services are provided as a service, but neither source or object code of the software used to provide the service is delivered or subscribed by you or any user, nor are you or any User entitled to access of such software source code.

4.2 Technical requirements for use of the Subscription Services

4.2.1 You are responsible for providing and installing the necessary browser software for presentation and use of the Subscription Services. You recognize that the usage of our Subscription Services is dependent on the appropriate choice of browser software. You can obtain information as to which browser software can be used in the SMART-TRIAL Security & Service Level Statement. We are entitled, without notice, to change our software such that you are required to obtain and install a new browser software. You are also responsible for connecting to our servers as well as reestablishing and maintaining such a connection.

4.3 Compliance with Service Terms and Conditions

4.3.1 You are committed to ensure that your Users are informed of and compliant with the Agreement, and to respect our intellectual property rights, hereunder copyright. We are entitled at any time to review your usage of our Subscription Services to ensure that the Agreement is complied with.

4.3.2 Your breach of this Agreement gives us the rights, in addition to fees, for incorrect/unauthorized use of our Subscription Services, to claim compensation in accordance with Danish Law.

5.0 WARRANTIES

5.1 Subscription Services are provided during the term of this Agreement on a 24/7 basis according to the service availability set forth in the SMART-TRIAL Security & Service Level Statement, it being understood that the services may be inaccessible or inoperable from time to time for any reason, including, but not limited to:

  • equipment malfunctions
  • periodic maintenance procedures or repairs which we may undertake from time to time
  • causes beyond our control or which are not reasonably foreseeable by us, including, but not limited to, interruption or failure of telecommunication or digital transmission links, delays or failures due to your or other Users’ internet access connections, hostile network attacks, network congestion or other Force Majeure Events (defined in section 14.0 of this Agreement).

5.2 You agree that we have no control over the stability and throughput speed of the Internet or other data transmission systems used by you or other Users. We disclaim any liability for loss or damage attributable to your own connection to our Subscription Services, including lack of connectivity, system crashes, etc. This also applies to your other computer equipment, browser software, etc.

5.3 Our service targets follow our infrastructure service provider service level targets, which are set to at least 99.9% availability over the course of a 12-month period.

5.4 We are not responsible for making Subscription Services available under the following conditions:

  • Service windows notified accordingly in advance.
  • Errors and crashes for any reason, that occur in your own network, power-or IT-system, hardware, including system software, as well as lack of access to your own network and an active Internet connection.
  • Errors and crashes for any reason that occur because of an incompatibility between the your IT system and the Services.
  • In cases that are to be classified as emergencies and which require an extraordinary service window, services or maintenance windows are to be announced at least 24 hours in advance.
  • Emergency service windows are only announced in cases where security issues are discovered.

5.5 However, our liability for loss or damage shall in no event, except for gross negligence and intent, exceed an amount equivalent to one-twelfth of the annual Subscription Fee that you have paid to us.

5.6 Your exclusive remedy and our sole liability under this Agreement shall be for us to correct any material failure of Subscription Services to perform as promised, as long as you, at our request, provide us with sufficient information (which may include information about your computer system to reproduce the defect in question). In the event that we cannot, after repeated efforts, remedy such failure, we shall refund all payments received by us from you hereunder and terminate this Agreement, and your use of Subscription Services shall terminate.

6.0 UPDATES AND AMENDMENTS TO Subscription Services

6.1 We have the right to regularly update and amend Subscription Services when we deem it necessary. Such updates or amendments do not restrict or provide changes in your obligations to us. Furthermore, such updates or amendments to Subscription Services do not provide you with a right to claim breach of contract against us.

6.2 We are also entitled to make changes to the functionality of our Subscription Services, including removal, and or changes in functions, which we deem necessary to provide the best possible service to our customers. Only we are entitled to determine the functionalities which meet these requirements. Such changes in the functionality of the Subscription Services entail no restrictions or changes in your obligations to us, such as any changes of Subscription Services do not give you the right to claim breach of contract against us.

7.0 SMART-TRIAL’S RIGHTS AND OBLIGATIONS

7.1 We retain full ownership of all Subscription Services and other Services, and we are entitled to occupy Subscription Services and other Services with no restrictions of any kind from you or any third party.

7.2 Should you require any additional Services in relation to your use of our Subscription Services, such Services shall be agreed upon in writing between SMART-TRIAL and the Customer, such as through a Quote.

7.3 You are not allowed to use Subscription Services in such a way that it violates our rights, or in other way harms us.

7.4 We collect and process Customer Data for security reasons to improve our Subscription Services and any related Services. We have described how we process Customer Data in our Privacy Policy.

7.5 e, or a third party from whom we derive our rights, have copyright and every other right to SMART-TRIAL’s Subscription Services, including all software code, html-code, JavaScript code, CSS code, text, images, or other elements, which you might gain access to through the Subscription Service. The copyright also includes any physical materials, including user manuals and training materials provided by us to you. You shall respect our rights and you are responsible without limitation for infringement of these rights, including unauthorized disclosure of Subscription Services and other Services with third parties.

8.0 TRANSFER OF RIGHTS

8.1 Transfer of your rights and obligations under the Agreement can only take place with your Affiliates. Transfer of your rights and obligations under the Agreement to any other third party not considered an Affiliate, cannot take place unless agreed in writing.

8.2 We cannot assign, or re-assign, our obligations to you or your Subscriptions to a third party, except as part of a merger and/or acquisition of SMART-TRIAL. You are not entitled to terminate the contract solely on the basis of such an event.

9.0 SUBSCRIPTION FEES AND SUBSCRIPTION PERIOD

9.1 All Subscription Fees and any additional fees shall follow the pricing detailed and agreed to in your Quote from us.

9.2 Unless otherwise stated in the Quote, the minimum Subscription Period for any Subscription Service is thirty (30) days, and a Subscription is renewed automatically at the end of each Subscription Period unless cancelled. If Billing Period differs from the Subscription Period, it must be specified in a Quote from us.

9.3 Unless otherwise stated in the Quote, SMART-TRIAL eCRF, SMART-TRIAL ePRO, SMART-TRIAL Suite and SMART-TRIAL Cases Subscription requires a minimum of two (2) consecutive Subscription Periods.

9.4 Unless otherwise stated in the Quote, we will invoice you for the Subscription Services you have requested at the start of each Subscription Period (up-front) and each subsequent Billing Period following renewal of your Subscription. Additional Services are invoiced as described in your Quote from us

9.5 Subscription is required for ongoing Studies, i.e. SMART-TRIAL Studies that are in "Collecting Data" or "Amendment" modes. Subscription is also required for SMART-TRIAL Studies in “Completed” mode, to which a different Subscription Fee may be collected.

9.6 Upon renewal of the Subscription Period we may amend your Subscription Fees without notice e.g., if you exceed your maximum applicable limits, such as any applicable Study Storage Size limits or use limits depicted in your Quote, or you subscribe to additional Subscription Services, such as add-ons. We may also amend the Subscription Fees according to our current list price if needed, if this amendment applies to you, we will notify you at least thirty days in advance of the renewal and the amended Subscription Fees will apply at the start of the next Subscription Period. If you do not agree to the amended Subscription Fees, either party can choose to terminate the Agreement in accordance with section 10.0.

9.7 f not stated otherwise in the Quote, a Subscription and Billing Period starts as soon as a Study is started (i.e. placed into “Collect Data” mode) and Subscription renewal can only be cancelled by placing a Study into “Completed mode”, deleting the Study, or by written notice to help@smart-trial.com from you at least 15 days prior to the end of the current Subscription Period.

9.8 We do not refund any Subscription Fees for an unused Subscription Period.

9.9 Studies in “Completed Mode” may require an archiving Subscription which is invoiced in advance for 12 months at a time, unless otherwise stated in the Quote.

9.10 All amounts invoiced are due and payable within eight (8) days from the date of the invoice, unless otherwise specified in the Quote.

10.0 TERMINATION

10.1 Unless otherwise stated in the Quote this Agreement may be terminated by either party with a 15-day prior notice to the end of the current Subscription Period. Notification of termination of contract must be addressed in writing to help@smart-trial.com. All terms of this contract still apply during the notice period.

10.2 n the case where either Party terminates the Agreement, we shall store data for 3 months, after which they will be permanently deleted.

10.3 We do not refund or credit payments for a Subscription Period upon termination.

11.0 BREACH OF TERMS

11.1 In the case where one of the parties breaches the terms set in this Agreement or the associated Online Data Processing Terms (Appendix 1 or 2), the other party is entitled to terminate the Agreement.

11.2 In the case that the Agreement is terminated because of a breach, we shall store data for three months, after which the data will be permanently deleted.

12.0 TRADE SECRETS

12.1 Technical information, know-how, concepts, methods, intellectual property rights and related information, which is developed or owned by us is regarded as our trade secrets.

12.2 The data on your products, protocols, procedures, and subject specific data shall be regarded as confidential information and is owned by you. All intellectual property rights evidenced by or embodied in the Data shall be owned solely by you.

12.3 Each party is obliged to keep all information they receive about each other confidential. This shall be the case whether the Agreement has been terminated or not.

12.4 The parties are entitled to disclose sensitive information to its employees and own advisors on a “need to know” basis to the extent that disclosure meets the purpose of the present Agreement.

13.0 LIMITATION OF LIABILITY

13.1 We will obtain product liability insurance to comply with our obligations under this Agreement.

13.2 SMART-TRIAL shall have no liability to Subscriber for any indirect or consequential damages arising from SMART-TRIAL, including operating losses, loss of anticipated profit, penalties, loss and/or damage of data, loss of goodwill as well as all other forms of consequential damages.

13.3 Except for losses which result from our negligence of willful misconduct, we are not responsible for losses that might arise as a result of your inability to use SMART-TRIAL, regardless of the cause thereof and regardless of us previously being advised of the possibility of such as loss.

13.4 Except for losses which result from our negligence or willful misconduct, our liability for loss or damage shall in no event exceed an amount equivalent to the Subscription Fee that you have paid to us in the Subscription period during which the damage may have occurred.

13.5 We disclaims any liability for loss or damage attributable to your own connection to our services, including lack of connectivity, system crashes, etc. This also applies to your other computer equipment, browser software, etc.

13.6 We disclaim any responsibility for seeking informed consent to the processing of personal data by your or your customers patients/research subjects, and related tasks.

13.7 Your breach of these terms gives us rights, in addition to fees for incorrect/unauthorized use of SMART-TRIAL, to claim compensation in accordance with Danish Law.

14.0 FORCE MAJEURE

14.1 Neither Party shall, in relation to the present Agreement, be held responsible for the other Party in respect to matters which are beyond the Party’s control and which the Party could not have taken into account when accepting the Agreement and could not have avoided or overcome. These matters include but are not limited to strike or other workforce related complications, over which the Parties have no control, fire, war, riot, mobilization or unforeseen military calls, monetary restrictions, lack of transport, lockouts, limit of products, restriction of assets, shortcomings in delivery, virus in SMART-TRIAL, or delays from sub-contractors.

15.0 GOVERNING LAW AND JURISDICTION

15. 1 The present Agreement is subject to Danish Law. Any disputes arising in connection with the Agreement, including disputes regarding its existence or validity, shall be settled by the court of Aalborg (Byretten i Aalborg).

16.0 AUDITING

16.1 Once a year, you shall have the right to request a copy of an internal audit report from us, in order to verify compliance with the Agreement and the quality, technical, service, and security measures described in the SMART-TRIAL Security & Service Level Statement and SMART-TRIAL’s GCP, FDA 21 CFR Part 11, and HIPAA Compliance Statement

16.2 You can request access to our compliance documentation depot, which contains documents to verify our compliance towards regulatory frameworks and industry standards.