1. Terms and Conditions 

  1. These terms and conditions (“Terms and Conditions”) govern the Service (as defined below) provided by Banook Group., whose registered office is in 84 Avenue du XXieme Corps, 54000 Nancy, France (“The Company”). 
  2. The Company provides the Service through the mobile application b.research (“App” or, for purposes of these Conditions of Use, “b.research”) accessible by Users (as defined below); and linked to the EDC platform, as defined below, for Professional Users (as defined below) monitoring activity (“Dashboard” and, together with the App, “b.research Platform”). 
  3. By using the App, the User accepts these Terms and Conditions. 
  4. The Company reserves the right to change and update these Terms and Conditions at its sole discretion. The User will be notified of any changes, which will become effective on the date of the related notification.  
  5. The User’s use of the App after having been notified of changes constitutes his/her full acceptance of the changes made to these Terms and Conditions. 

2. Definitions 

  1. “App”: has the meaning given in clause 1.2. 
  2. “Clinical Site”: means the investigative site, hospital or facility where a clinical research study (“Clinical Trial”) or, if applicable, a Health Project as defined below, is run and which determines which Users to enroll in a Clinical Trial or Health Project, the investigator, the sub-investigators, healthcare professionals and associated personnel. 
  3. “Credentials”: has the meaning given in clause 7.2. 
  4. “CRO”: stands for Contract Research Organization, which means a person or an organization that may be engaged by the Sponsor to perform one or more tasks and functions related to a Clinical Trial. The CRO may be the Customer. 
  5. “Customer”: means an entity, individual or business, purchasing The Company Services, pursuant to a contract or an order. The Customer may be the Sponsor or Clinical research Organization (CRO) acting on behalf of the Sponsor of the Health Project. 
  6. “Dashboard”: has the meaning given in clause 1.2. 
  7. “Data Transfer Agreement”: means the agreement that governs the transfer of Professional Users’ and Users’ data between The Company and the Customer and/or the Professional Users responsible for a Health Project and establishes the related safeguards, rights, legal obligations and restrictions, including to ensure compliance with the law and applicable regulations, related to this data transfer between the Parties and defines the specific purposes the data may be used for. 
  8. “Data Protection Legislation”: means any applicable data protection or privacy laws, including the EU Regulation n° 2016/679 also referred to as the General Data Protection Regulation (« GDPR ») and any other applicable laws that are similar or equivalent to or that are intended to or implement the GDPR.  
  9. “EDC”: refers to electronic data capture used for the purposes of the Health Project 
  10. “eDiary”: has the meaning given in clause 6.2.2 
  11. “ePRO”: refers to the validated electronic instruments used to collect the User reported outcomes, i.e., the reports provided directly by Users about their health, without the ability to modify or interpret the response from a clinician or anyone else. 
  12. “GDPR”: has the meaning given in clause 10.1. 
  13. “Health Information”: has the meaning given in clause 6.2.3. 
  14. “Health Project”: means a health project, whether a Clinical Trial or not, run by the Customer for itself or on behalf of a Sponsor, in relation to which the Services are provided by The Company, to investigate different health projects, including but not limited to the safety or effectiveness of a drug, diets and medical device. 
  15. “Investigator”: means the person responsible for working within a Clinical Trial or other Health Project at a Clinical Site. 
  16. “Module”: has the meaning given in clause 6.2. 
  17. “ b.research”: has the meaning given in clause 1.2. 
  18. “ b.research Platform”: has the meaning given in clause 1.2. 
  19. “The Company”: has the meaning given in clause 1.1. 
  20. “Personal Data”: means any information, including health records, clinical records and User reported outcomes (PROs), related to an identified or identifiable natural person, as defined under applicable personal data protection and privacy laws. 
  21. “Professional User”: means the professional user, including the Sponsor, the CRO and the Investigator which will access and manage the data inserted in the App providing activities related to the Service. 
  22. “Privacy Code”: has the meaning given in clause 10.1. 
  23. “Privacy Notice”: means the document that informs Users and Professional Users of the Service, as the case may be, on the management and processing of their Personal Data, as further specified in clause 10. 
  24. “Questionnaire”: has the meaning given in clause 8.3. 
  25. “Reasons of Force Majeure”: has the meaning given in clause 18. 
  26. “Service”: means the service provided by the b.research Platform related to ePRO in Health Projects, which is provided with a variety of modules designed for data collection in Health Projects to improve both User’s experience and the data quality for Health Projects. Data quality in relation to a Health Project covers authenticity and completeness. 
  27. “Service Owner”: means The Company. 
  28. “Sponsor”: means the individual, company, institution or organization responsible for the inception, management and/or financing of a Health Project and that benefits from the Service under a separate agreement. 
  29. “User”: means a User participating to a Health Project and, in case of Clinical Trial, authorized by the Professional Users, who is enabled to use the App upon acceptance of these Terms and Conditions. 

3. Purpose of the App 

  1. b.research is available on the app stores of mobile platforms and collects and analyses clinical data produced in Health Projects. b.research helps Users in their experience in Health Projects they are participating in, whilst also ensuring data quality in Health Projects. The collected and shared data, whether clinical or not, allows Health Care Professional Users to understand the state of health of Users involved in Health Projects. 
  2. The data provided by Users and collected through the App is made available to the Customer separately, not in the App. The data is therefore processed by the Customer and provided to Professional Users, whose level of access to the data are pre-defined depending on the Health Project. 
  3. b.research is autonomous software that collects and analyses Electronic Patient Reported Outcomes (PROs) such as questionnaires, electronic diary, surveys, scales… and focuses on each User’s involvement in a Health Project. 
  4. b.research is, and must be exclusively used as, a tool for sharing clinical data. For this reason, The Company can in no way be held liable for dealings between Customer, Sponsor or Investigators and Users. 
  5. b.research is not a diagnostic tool or an automatic treatment tool for any pathology.  b.research is provided to Users to collect information and health data relating to the state of their health whilst they participate in a Health Project. 
  6. b.research is not a substitute for consultation with, or diagnosis or treatment by, a qualified medical professional, whom Users should contact if they have doubts regarding their state of health. 

4. Ownership of the App 

  1. The Company exclusively owns b.research or has obtained the necessary authorizations to use it, specifically: (i) the source code/s, (ii) the algorithm, (iii) the graphical interfaces, (iv) the content, and (v) the word and figurative trademarks used on b.research. 
  2. The User is not authorized to use, copy, reproduce, distribute, translate, adapt, modify, publish, distribute to the public or otherwise exploit b.research’s features, instruments or content, or create works deriving from them, in any form or by any means, in whole or in part, unless otherwise expressly permitted by these Terms and Conditions. 

5. Conditions for using the App

  1. Use of the App is permitted only to Users who are natural persons who downloaded the App, read the Privacy Notice, consented to personal data processing if required, and accepted these Terms and Conditions. 
  2. More specifically,  b.research can be used by Users who: (i) are instructed by Investigators to download the App to enable the collection of their PROs; (ii) are enrolled in a prospective Clinical Trial; and/or (iii) receive treatment as part of a cohort or registry-based Clinical Trial, including as part of pharmacovigilance activities; (iv) are generally involved in a Health Project that involve the processing of health personal data . 

6. Content of the App 

  1. b.research gives Users direct access from their own mobile devices to the modules available through the App. 
  2. Depending on the Health project, Users can have access to the following modules through the App (“Modules”), among others: 
    • Questionnaires: this module uses the User’s data – provided through the App, by filling in the given questionnaires (ePROs) according to the parameters of a given Health Project. 
    • eDiary: this module collects data regarding symptoms or medication intake from the User’s answers to standard questions from the Sponsor. 
    • Health Information: this module allows Users to access Sponsor-approved articles in the App. 

7. Registration 

  1. Every User participating in a Health Project is given a pseudonymized User ID number that is valid for the duration of that Health Project. 
  2. To use b.research, the User needs to download the App and log in for the first time using a specific project code. The code is provided to the User by the Investigator or the Health Care Professional User, when applicable. The User needs to enter a partial date of birth upon first connection (month+year) to activate the account. Once the account is activated, the User can access the App using a PIN or, if available, his/her biometric data (“Credentials”). 
  3. The User must keep the Credentials confidential and not share them with third parties. If the User experiences problems with his/her account or Credentials, he/she must contact The Company without delay. The Credentials are personal, relate to the User only and cannot be transferred to third parties. 
  4. The User alone is responsible for using all suitable means to ensure the Credentials remain confidential. 
  5. Each User is responsible for all activities performed using his/her account or Credentials and will inform The Company of any use that is unauthorized or otherwise contrary to these Terms and Conditions. 
  6. The Company will in no way be held liable for any damage, of any nature, the User suffers as a result of any use of his/her own account or Credentials, whether by the User or third parties, that is unauthorized or otherwise contrary to these Terms and Conditions. 

8. Use of b.research 

  1. After registration, which is completed upon the User’s acceptance of these Terms and Conditions and, if required, consent to the processing of his/her personal data, b.research will guide the User through onboarding screens and offer him/her the possibility to access the Modules. 

9. User’s right and obligations 

  1. By accepting these Terms and Conditions, the User: 
    • Agrees, under his/her responsibility, to provide the PROs (the methods of processing the data are described in the related Privacy Notices); and 
    • Will use b.research only to receive the Service as described in these Terms and Conditions. The User provides his/her data in b.research free of charge and cannot bring any claims against The Company for using the data provided that such usage is made in compliance with any applicable data protection and privacy legislation . 
  2. By accepting these Terms and Conditions, the User acknowledges that The Company, through b.research, will collect, process, also by using third-party software, and use pseudonymized data for statistical analysis and to verify proper use of the Service. 
  3. The User may delete his/her App account at any time. If the User decides to stop using b.research, the use of the data the User shared before he/she stopped using the App is governed by the privacy Notice.If the User does not accept these Terms and Conditions or delete the App, he/she will be unable to participate in the Health Project through the App. In that case, if applicable, the User will need to contact the Clinical Site or the relevant contact person of the Health Project to understand how to proceed with the Health Project. 

10. Privacy 

  1. b.research complies with the applicable data protection and privacy legislation. The Personal Data supplied by the User, including the PROs, will be processed in accordance with applicable law, including EU Regulation 2016/679 (“GDPR”). 
  2. If required, the User can consent to the processing of his/her personal data for the methods and purposes set out in the Privacy Notice by selecting this option during registration. Personal Data will be used only for the purposes set out in the Privacy Notice and in accordance with the authorizations granted. 
  3. Further information regarding Personal Data processing is available in the Privacy Notice provided at the time of the User’s registration and can be viewed in the Support section of the App. 
  4. In case of inconsistency between these terms and conditions and the Privacy Notice as regards the protection of Users’ personal data and their rights as data subjects as per applicable data protection and privacy legislation, the latter shall prevail 

11. User’s responsibility

  1. The User is responsible for the correct use of the App and for the information provided to b.research. Each User represents and warrants that the information provided in the App is true and correct. The Company reserves the unconditional right to delete the account and deny the User access to the App if the information is found to be inaccurate or false. Users whose access to the App is blocked cannot create new accounts.  
  2. Users may use the content in the Articles section of b.research for personal use only connected to use of the App; they therefore cannot copy or share the content with third parties. 
  3. If any disputes are brought against Alira Health by third parties concerning the User’s data, content or alleged misconduct when using the App, the User will be held personally liable to the third parties and to The Company. 

12. Service Owner’s rights and obligations

  1. The Company, in its capacity as Service Owner, grants the User a worldwide, non-exclusive, non-sub-licensable license of use – non-transferable to third parties – throughout the period of use of the Service, to use the Service via the App. The User will have no claim over The Company’s property. 
  2. The Company, in its capacity as Service Owner, endeavors to keep the data, including Personal Data and all information received, in a suitable place for the appropriate amount of time, based on the intended use. Account data not used by the User in relation to the Service will be stored for the period required by law, in accordance with the Privacy Notice and, if required, the consent given in order to use the App and allow data processing during the use of the App. 

13. Use of specific technologies

  1. b.research may use content based on software developed and owned by third parties. 

14. Data supplied by third parties 

  1. The Company, in its capacity as Service Owner, neither controls nor manages information or data supplied by third parties and, therefore, third parties are solely responsible for the information and data they provide. 
  2. The Company, in its capacity as Service Owner, offers no guarantees regarding the content in the Articles section of b.research and assumes no responsibility in relation to the content. 
  3. The Company is in no way responsible for the veracity or accuracy of data and information inserted by the User through the App. 

15. Disclaimer

  1. b.research cannot cause damage or injuries to the User’s health if used in accordance with these Terms and Conditions. 
  2. b.research is not a substitute for consultation with, or diagnosis or treatment by, a qualified medical professional, whom the User should contact if he/she has any doubts regarding his/her state of health. 
  3. It is important not to delay a request for a medical consultation, ignore a doctor’s advice, or to start or interrupt any kind of health treatment based on information provided in b.research. 
  4. The Company, in its capacity as Service Owner, provides no guarantees regarding the content, thoroughness or accuracy of the information in the Scientific Articles section of b.research, without prejudice to application to mandatory laws. 
  5. The Company provides no guarantees and assumes no liability, within the limits of the law, for any direct or indirect damage (including, without limitation, damage from disruption of service or data loss) to the User from the use or impossibility to use the Service for reasons not directly attributable to The Company. 
  6. Any other liability mandatory by law is limited to the Service, thus expressly excluding any liability for direct and/or indirect damage that is the consequence of the User’s or third parties’ misconduct, i.e., abusive access or use of data, including Personal Data. 

16. Limitations in providing the Service 

  1. The Company reserves the right to amend, suspend or cancel, in whole or in part, the Service at any time, including without notice. 
  2. The Company cannot be held liable for any damage resulting from a failure to provide the Service because of malfunctions or failures in electronic communication devices for reasons not attributable to Alira Health. 
  3. The Company will notify the User through the App of any suspensions or cancellations of the Service. 

17. Term

  1. These Terms and Conditions apply for the period the User uses the Service. 

18. Force majeure 

  1. The Company is exempt from any liability for the failure or delay in fulfilling its obligations under these Terms and Conditions, or arising from the suspension of – or impossibility to access – the Service offered through b.research due to force majeure events out of its reasonable and foreseeable control, including, but not limited to, national strikes, terrorist attacks, civil insurrections, fires, explosions, internet or electronic device (including mobile phone) malfunctions for any reason, blackouts, and calamities of an exceptional nature (“Force Majeure Events”). 
  2. Upon occurrence of a Force Majeure Cause, The Company will promptly notify the User through the App. 
  3. The Company’s fulfilment of its obligations under these Terms and Conditions will be suspended for the period of any Force Majeure Events. 

19. Validity and amendments

  1. These Terms and Conditions apply, where necessary to other different and specific agreements. 
  2. The Company may make changes to these Terms and Conditions at any time, at its own discretion and unilaterally, in which case it will notify the User through the App. 
  3. The User’s use of the Service after these changes constitutes his/her express acknowledgment and acceptance of the changes and updates. The Service Owner will request the User’s express acceptance of the changes if required. 

20. Partial Severability 

  1. If any clauses of these Terms and Conditions are held to be invalid, illegal or unenforceable by law, competent authorities or court decisions, the remaining clauses will be unaffected. 

21. Governing law and jurisdiction

  1. The relationship between The Company and the User is governed by French law. 
  2. Without prejudice to any applicable laws, any disputes arising out of or in connection with these Terms and Conditions will be subject to the exclusive jurisdiction of the competent Court of Paris. 

Last update on 11SEPT2023

Version: 1.3