Terms of Service

This Agreement was last revised on October 02, 2017.

By placing an order or using or accessing any ClinCapture service or related service, you agree to all the terms and conditions of this Terms of Service ("Terms") with Clinovo Inc dba ClinCapture, a Delaware corporation hereinafter referred as ("ClinCapture", "we", "us", "our") for good and valuable consideration, you ("Customer") hereby agree to be bound by these Terms. You represent and warrant that you have the legal power and authority to enter into this Agreement and that, if the Customer is an entity, this Agreement and each "Order Form" is entered into by an employee or agent with all necessary authority to bind that entity to this Agreement. Please note that we may modify this Agreement as further described in the amendments section below, so you should make sure to check this page from time to time

As a convention, defined terms are capitalized and are defined in Definitions (section 12) below.

  1. PRIVACY

    ClinCapture is strongly committed to protecting Customer privacy. Please review our Privacy Policy to learn about how and when ClinCapture collects, uses, and shares Customer information upon use of its Services.

  2. HOSTING AND MANAGEMENT SERVICES

    1. Performance of Services: Subject to Customer's compliance with the terms and conditions contained herein, ClinCapture will perform the Hosting and Management Services in accordance with these Terms.
    2. Limits: Usage limits and pricing that apply to you will be specified in your "Order form", this agreement, or at time of subscription plan purchase online. If we make modifications to the limits or pricing, these modifications will not apply to you until the start of your next renewal period. Upon renewal, the current product usage limits and pricing will apply to your subscription, unless a new agreement is entered into before current subscription renewal date.
    3. Modifications: We modify the Subscription Service from time to time, including by adding or adjusting features and functions, in an effort to improve your experience. But we will not make changes to the Subscription Service that materially reduce the functionality of the Subscription Service provided to you during the Subscription Term. We might provide some or all elements of the Subscription Service through third party service providers.
    4. Additional modifications: ClinCapture reserves the right to modify or replace this Agreement at any time and in ClinCapture's sole discretion. ClinCapture will indicate at the top of this Agreement the date such document was last updated. ClinCapture will post the revised version on the website or make such modified or new Agreement available through the website or such other methods as determined by ClinCapture. Any modifications or replaced terms will be effective following your renewal of this Agreement. Your continued use of the ClinCapture Hosting and Management Services or renewal of this Agreement following the posting or availability of any changes to this Agreement will constitute your acceptance of such change.
    5. Additional features: You may subscribe to additional features of the Subscription service by agreeing to a new "Order form".
    6. Suspension or Termination of Authorized User: ClinCapture may suspend or terminate an Authorized User's access to the Hosted System if ClinCapture reasonably determines that an Authorized User has violated the terms and conditions of this Agreement or applicable law, or suspension or termination is otherwise necessary to protect the integrity of the Hosted System or any Customer Data. ClinCapture will provide Customer with forty-eight hours' prior notice of any planned suspension or termination; provided, that ClinCapture may provide Customer with notice following such suspension or termination if ClinCapture reasonably determines that immediate suspension or termination is required. In all events, Customer will be liable for any violation of the terms and conditions of this Agreement by any Authorized User.
    7. Suspension or Termination of Customer Access: ClinCapture may suspend or terminate the Customer's access to the Hosted System if ClinCapture reasonably determines that Customer has violated applicable law or the terms and conditions of this Agreement, including but not limited to allowing unauthorized access to the Hosted System, or suspension or termination is otherwise necessary to protect the integrity of the Hosted System or any Customer Data. ClinCapture will provide Customer with prior notice of any planned suspension or termination; provided, that ClinCapture may provide Customer with notice following such suspension or termination if ClinCapture reasonably determines that immediate suspension or termination is required. In all events, Customer will be liable for any violation of the terms and conditions of this Agreement by any Authorized User or any other unauthorized user that has been allowed access as a result of any act or omission on the part of Customer.
    8. Customer Data: Customer acknowledges and agrees that ClinCapture does not monitor communications or Customer Data transmitted through the Hosted System and that ClinCapture will not be responsible for the content of any such communications or Customer Data. Customer is responsible for its use of the Hosted and Management Services, for any Customer Data it uploads to the Hosted Applications, and for any consequences thereof. ClinCapture will not be responsible for the content or outcome of Customer Data hosted on its Hosted Application. ClinCapture will not be responsible for any loss, destruction, alteration, unauthorized disclosure or corruption of Customer Data. Under no circumstances will ClinCapture be liable for any consequential damages or data recovery costs incurred by Customer.
  3. CUSTOMER OBLIGATIONS

    1. Authorized Users: Customer will require each affiliated employee or contractor ("Potential User") who desires to access and use the Website and Hosted Systems to complete Customer's registration process. Customer will issue passwords or access codes only to a Potential User who has completed Customer's registration process. In addition to the foregoing, Customer will ensure that each Potential User that desires to access and use the Hosted System assents to these Terms, which will be displayed on initial Hosted System sign-on. Each such Potential User who assents to ClinCapture's terms of services is thereafter deemed to be an "Authorized User".

      In order to use ClinCapture's Services, an Authorized User must:

      1. be at least eighteen (18) years old and able to enter into contracts;
      2. complete the registration process;
      3. agree to the Terms;
      4. provide accurate and verifiable contact information; and
      5. provide accurate billing information.

      By using the Hosted System, Authorized User represents and warrants that it meets all the requirements listed above, and that Customer will not use the Hosted System in a way that violates any laws or regulations. ClinCapture may refuse service, close accounts of any users, and change eligibility requirements at any time.

    2. Enforcement: Customer will use (and will ensure that Authorized Users use) the Hosted System exclusively for authorized and legal purposes, consistent with all applicable laws, regulations and the rights of others. Customer will promptly notify ClinCapture of any suspected or alleged violation of the terms and conditions of this Agreement and will cooperate with ClinCapture with respect to: (a) investigation by ClinCapture of any suspected or alleged violation of this Agreement and (b) any action by ClinCapture to enforce the terms and conditions of this Agreement.
    3. Restrictions: Customer will not attempt to interfere with or disrupt the Hosted System or attempt to gain access to any systems or networks that connect thereto. Customer will not: (a) copy, modify or distribute any portion of the Hosted System; or (b) rent, lease, resell or provide access to the Hosted System on a time-share or service bureau basis; or (c) transfer any of its rights hereunder.
    4. Licenses: For the avoidance of doubt, ClinCapture is not responsible for providing medical coding, or any other licenses which may or may not be required, including, but not limited to WHO, MedDRA, or other standardized codes for medications and adverse events.
    5. Telecommunications and Internet Services: Customer acknowledges and agrees that Customer's use of the Hosted System is dependent upon access to telecommunications and Internet services. Customer will be solely responsible for acquiring and maintaining all telecommunications and Internet services and other hardware and software required to access and use the Hosted System, including, without limitation, any and all costs, fees, expenses, and taxes of any kind related to the foregoing. ClinCapture will not be responsible for any loss or corruption of data, lost communications, or any other loss, damage or performance limitation of any kind arising from any such telecommunications and Internet services. ClinCapture will not be liable for any interruption of service or access related to a failure or disruption of internet server or connection, whether affecting Customer, or ClinCapture.
    6. Cooperation: Customer will at all times provide ClinCapture with good faith cooperation and assistance as may be reasonably required by ClinCapture to perform the Installation Services and the Hosting and Management Services.
  4. PAYMENT

    Customers can increase the number of "sites" and/or add additional features, "Paid Services", to their accounts for a fee. When limits are reached, invoices will be automatically increased accordingly beginning with the next invoice.

    1. Payment Terms: Customer shall pay each such invoice within fifteen (15) days of the invoice date. Any payment due under this Agreement not received by ClinCapture within thirty (30) days of the due date shall be subject to a late payment charge of 1.5% per month or the maximum rate allowed by law, whichever is less. You must pay these late charges when we bill you for them. We may use a third party to collect past due amounts. You must pay for all reasonable costs we incur to collect any past due amounts, including reasonable attorneys' fees and other legal fees and costs. We may suspend or cancel your Service if you fail to pay in full on time. All invoices shall be paid in full, without reduction or set off of any kind. Customer will pay all amounts due under this Agreement in the currency ClinCapture quoted your account. Except as specifically set forth in this section, all Services are prepaid for the period selected (monthly, quarterly, yearly or otherwise) and are non-refundable. This includes accounts that are renewed.
    2. Fees: The fees applicable for the Service ("Fees") are available on the "Order form" and/or in ClinCapture's then-current published price list. The price stated for the Service excludes all taxes and charges, unless stated otherwise. You're responsible for any taxes and for all other charges incidental to using the Services (for example currency exchange settlements,..). ClinCapture will provide Customer with a minimum of sixty (60) days' notice of any changes to any fees payable by Customer hereunder.

      In order to avoid additional charges, you should purchase the appropriate tier of subscription service for your anticipated needs. We will monitor or audit remotely the number of "sites" in the subscription services. If you exceed your Maximum number of "sites" in your subscription period, then your subscription fee will increase immediately up to the tier price (as set forth on our current price list) with corresponds with the maximum number of "sites" from your current usage. This process will continue during the subscription term. We determine the number of "sites", as described in our section 12. Once increased, your subscription fee will not decrease, even if there is subsequent reduction in the number of "sites".

    3. Subscription Period: You may elect one of the following subscription period and billing options:

      A quarterly subscription plan ("Quarterly Subscription Plan"). The subscription period for the quarterly Subscription Plan will be one quarter and will automatically renew for additional successive quarterly periods unless: (i) you cancel your Quarterly Subscription Plan in accordance with these Terms at least thirty (30) days prior to the renewal date or (ii) otherwise stated on the applicable Order Form. Pricing for any Subscription Term renewal, new Order Form or Order Form change will be at ClinCapture's then-applicable rates unless you and we agree otherwise.

      You will be billed quarterly for the Quarterly Subscription Plan on the deployment date or about the first day of each quarter until such time that you cancel your Quarterly Subscription Plan.

      An annual subscription plan ("Annual Subscription Plan"). The subscription period for the Annual Subscription Plan will be one year and will automatically renew quarterly on the anniversary of the deployment date unless : (i) you cancel your Subscription Plan in accordance with these Terms at least thirty (30) days prior to the renewal date or (ii) otherwise stated on the applicable Order Form. Pricing for any Subscription Term renewal, new Order Form or Order Form change will be at ClinCapture's then-applicable rates unless you and we agree otherwise.

      You will be billed annually for the Annual Subscription Plan. For the avoidance of doubt, please note, you will not be permitted to cancel, or downgrade the Service you have selected until the anniversary of your Annual Subscription Plan and/or fees related to the initial annual term are paid in full. There will be no refunds for Annual Subscription Plan payments.

      If you select the Quarterly Subscription Plan, you can switch to the Annual Subscription Plan at any time. If you select the Annual Subscription Plan, you may not change to the Quarterly Subscription Plan until the end of the one-year term of your Annual Subscription Plan.
    4. Credit Card: Some customers may have the option to pay by credit card, if customers are paying by credit card it authorizes us to charge your credit card for the service and no credit or refunds will be available. You must be authorized to use the credit card that you enter when you create a billing account. You authorize us to charge you for the Service using your credit card and for any paid package that you choose by using the service. Customer is responsible for providing accurate billing contact information and must notify ClinCapture immediately upon any change to billing contact information. ClinCapture may charge Customer's credit card yearly, quarterly, monthly or more frequently if ClinCapture determines it is warranted by Customer fees incurred.

      At ClinCapture's discretion, it may place an authorization hold on Customer credit card at any time for fees that Customer has already incurred. Fees that are not disputed within fifteen (15) days of the date on which they are charged will be conclusively deemed to be accurate.
  5. OWNERSHIP

    As between ClinCapture and Customer, only ClinCapture shall be deemed to own all right, title and interest in and to the Hosted System and any software programs, tools, specifications, ideas, concepts, know-how, processes and techniques used by ClinCapture or its employees or subcontractors in connection with performing the Hosting and Management Services, including all Intellectual Property Rights therein. Nothing in these Terms shall constitute a license or transfer any rights to any of the Intellectual Property contained in the Hosted System to Customer. Nothing in these Terms will be deemed to prohibit or limit ClinCapture's right to perform similar services for any other party during or after the term of this Agreement.

  6. WARRANTY

    1. Services Warranty: ClinCapture warrants that the Hosting and Management Services will be performed in a good and workmanlike manner, consistent with generally accepted industry standards. As Customer's sole and exclusive remedy, and ClinCapture's entire liability for any breach of the foregoing warranty, ClinCapture will, at its sole option and expense, promptly re-perform any Hosting and Management Services that fail to meet this limited warranty or, if ClinCapture is unable to re-perform the Hosting and Management Services to conform to the foregoing warranty, refund to Customer the fees paid for the nonconforming Hosting and Management Services. ClinCapture will not be liable for any consequential or subsequent losses or damages sustained by or claimed by Customer for loss or interruption of services, or failure of the Hosting and Management Services to be provided in accordance with Customer's expectations or otherwise.
    2. Regulations: ClinCapture represents and warrants that it will conform to and comply with all applicable statutory or regulatory requirements imposed by any federal or state law, rule, regulation or order and any intermediary regulations with regard to the Hosted System, and that ClinCapture has obtained or will obtain all permits, licenses and other authorizations necessary to commence and continue its performance under this Agreement.
    3. Disclaimer: EXCEPT AS EXPRESSLY SET FORTH HEREIN, THE HOSTED SYSTEM IS PROVIDED "AS IS," WITHOUT WARRANTY OF ANY KIND. WITHOUT LIMITING THE FOREGOING, EXCEPT AS EXPRESSLY PROVIDED IN SECTION 6.a, CLINCAPTURE DISCLAIMS ANY WARRANTY THAT THE HOSTED SYSTEM WILL BE ERROR-FREE OR UNINTERRUPTED OR THAT ALL ERRORS WILL BE CORRECTED. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED FROM CLINOVOCLINCAPTURE OR ELSEWHERE WILL CREATE ANY WARRANTY NOT EXPRESSLY STATED IN THIS AGREEMENT.
  7. TERMINATION

    1. Paid Services: Subscription service will commence on the Effective Date and will remain in effect until terminated.
      1. Termination for Convenience: Either party may terminate Subscription service at any time after the initial term of one year with thirty (30) days written notice to the other party. All fees shall be fully earned when payable and shall be non-refundable.
      2. Termination: Either party, upon giving written notice to the other party, may terminate this Agreement: (a) if the other party breaches any material provision of this Agreement and fails to cure such breach within thirty (30) days after receipt of written notice thereof from the other party; or (b) immediately in the event the other party terminates or suspends its business, becomes subject to any bankruptcy or insolvency proceeding under federal or state statute, or becomes subject to direct control by a trustee or similar authority. All fees shall be fully earned when payable and shall be non-refundable.
    2. Obligations Upon Expiration or Termination: Upon expiration or termination of this Agreement: (a) Customer's right to access and use the Hosted Applications will immediately terminate; (b) each party will promptly transfer to the other party or, at such other party's request, destroy, any Confidential Information of the other party, including all copies and portions thereof, and provide such party with an officer's written statement certifying to its compliance with the foregoing; and (c) Customer will, within thirty (30) days of receipt of ClinCapture's invoice, pay any and all fees accrued by ClinCapture as of the effective date of expiration or termination.
    3. Disposition of Customer Data: Upon the expiration or any termination of this Agreement ClinCapture will have the right to destroy or otherwise dispose of any Customer Data in its possession unless ClinCapture receives, no later than ten (10) days after the effective date of such expiration or termination, a written request for the data transfer or delivery to Customer of the Customer Data as described below:
      1. Data Transfer: Upon termination, ClinCapture will offer to Customer to export some or all Customer Data into an agreed format. Customer Data is stored in hosted databases in a specific format, and will require processing to export, map and translate into the desired format. ClinCapture will provide Customer with a statement of work detailing tasks, effort level and associated fees, at ClinCapture's standard rates, for exporting some or all of Customer's data. If Customer has paid fees to ClinCapture for extracting tools, such as CDISC or SAS, then Customer can choose to perform their own data exports with no additional fees prior to termination.
      2. ClinCapture will use all reasonable efforts to deliver the data to Customer within thirty (30) days of its receipt of such a written request. Customer will pay all reasonable expenses incurred by ClinCapture in transferring Customer Data to Customer.
    4. Survival: The rights and obligations of the parties under Sections 3.c, 5, 6, 8.d, 8.e, 9, 10, 11 and 12 will survive any expiration or termination of this Agreement.
  8. CONFIDENTIALITY

    1. Definition: "Confidential Information" means: any business or technical information of ClinCapture or Customer, including but not limited to any information relating to ClinCapture's or Customer's product plans, designs, costs, product prices and names, finances, marketing plans, business opportunities, personnel, research, development or know-how, that is disclosed in writing and is designated by the disclosing party as "confidential" or "proprietary" at the time of disclosure and, if orally disclosed, is summarized in writing and delivered to the receiving party by the disclosing party within thirty (30) days of such disclosure. All Customer Data is Confidential Information except where specifically excluded.
    2. Exclusions: Confidential Information does not include information that: (a) is or becomes generally known to the public through no fault or breach of this Agreement by the receiving party; (b) is rightfully known to the receiving party at the time of disclosure without an obligation of confidentiality; (c) is independently developed by the receiving party without use of the disclosing party's Confidential Information; (d) the receiving party rightfully obtains from a third party without restriction on use or disclosure; or (e) is disclosed with the prior written approval of the disclosing party.
    3. General Use and Disclosure Restrictions: Each party will not use the other party's Confidential Information except as expressly permitted within these Terms, and will not disclose such Confidential Information to any third party, except to employees and consultants who have a bona fide need to know such Confidential Information. However, ClinCapture may disclose Confidential Information of the Customer: (a) pursuant to the order or requirement of a court, administrative agency, or other governmental body, provided that the disclosing party gives reasonable notice to the other party to contest such order or requirement; and (b) on a confidential basis to its legal or financial advisors.
    4. Permitted Analytical and Knowledge Base Uses: ClinCapture may use Customer data for analytical purposes, including to improve and enhance the Hosted Services technology and to generate statistical information. ClinCapture may make such analytical and statistical information available to third parties, but only on a de-identified or aggregated basis. You hereby grant ClinCapture the following perpetual, non-exclusive, irrevocable, paid-up, royalty free, worldwide licenses: (a) the license, with right to sub-license to ClinCapture's service providers, to reproduce, internally distribute, internally display, create derivative works of, and use your data for the analytical purposes described above and to generate aggregated or de-identified (anonymized) data; and (b) the license, with right to sub-license, to make, have made, sell, offer for sale, use, import, reproduce, distribute, display, perform, and make derivative works of aggregated or anonymized data.
    5. Equitable Relief: Each party acknowledges that the unauthorized disclosure or use of the disclosing party's Confidential Information is likely to cause irreparable harm to the disclosing party, for which the award of damages will not be an adequate remedy. Consequently, the disclosing party shall be entitled to obtain preliminary and permanent injunctive relief to restrain such unauthorized disclosure or use, in addition to any other relief to which the disclosing party may be entitled at law or in equity.
  9. INDEMNIFICATION

    Customer agrees to defend, indemnify and hold harmless (including payment of reasonable attorneys' fees) ClinCapture from and against all liability to third parties based on claims for any reason related to this agreement or use by Customer of ClinCapture Services.

  10. LIMITATION OF LIABILITY

    1. Exclusion of Damages: In no event will ClinCapture or its Licensors be liable to Customer or to any third party for any special, incidental, punitive, exemplary or consequential damages (including loss of use, data or profits or for business interruption, or for the cost of substitute products or services) arising out of or in connection with this agreement or the use, performance or operation of the hosted system, whether such liability arises from any claim based upon contract, warranty, tort (including negligence), product liability or otherwise, and whether or not ClinCapture has been advised of the possibility of such loss or damage.
    2. Total Liability: ClinCapture's and its Licensors' total cumulative liability to Customer or to any third party from all causes of action and all theories of liability, will be limited to, and will not exceed, the total amounts paid to ClinCapture by Customer under these terms during the twelve (12) month period preceding the date a claim for liability arises hereunder.
    3. Acknowledgement of Risk: Customer acknowledges and agrees that the limitations and exclusions contained in Section 10 and elsewhere in these Terms represent the parties' agreement based upon the perceived level of risk associated with their respective obligations under this Agreement and the payments made hereunder. Customer further acknowledges and agrees that the provisions hereof that disclaim warranties, exclude consequential damages or other damages or remedies or limit liability shall remain fully valid, effective and enforceable in accordance with their respective terms, even under circumstances that cause an exclusive remedy to fail of its essential purpose.
  11. GENERAL

    1. Assignment: Customer may not assign these Terms in whole or in part, by operation of law or otherwise, without ClinCapture's prior written consent. Any attempt to assign these Terms, without such consent, will be null and void. Notwithstanding the foregoing, ClinCapture may assign this Agreement, without Customer's consent: (a) to a ClinCapture affiliate; or (b) to an entity that acquires all or substantially all of ClinCapture's assets or to any successor in a merger or acquisition involving ClinCapture. Subject to the foregoing, this Agreement shall inure to the benefit of the parties' respective successors and permitted assigns.
    2. Governing Law: The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the federal or state courts within Santa Clara County, California or within the Northern District of California for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in the federal or state courts within Santa Clara County, California or within the Northern District of California, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that a party is not subject to the jurisdiction of the above named courts, that its property is exempt or immune from attachment or execution based upon judgment or order of such court(s), that any suit, action or proceeding arising out of or based upon these Terms commenced in the federal or state courts located in the Northern District of California is brought in an inconvenient forum, that the venue of such suit, action or proceeding is improper or that these Terms or the subject matter hereof may not be enforced in or by such court. Should any party commence a suit, action or other proceeding arising out of or based upon these Terms in a forum other than the federal or state courts located in the Northern District of California, or should any party otherwise seek to transfer or dismiss such suit, action or proceeding from such court(s), that party shall indemnify and reimburse the other party for all legal costs and expenses incurred in enforcing this provision.
    3. Arbitration: The parties will undertake to use good faith efforts to settle all disputes arising under this Agreement. Failing settlement, all disputes will be referred to binding arbitration in the County of Santa Clara, CA, USA using the rules of the American Arbitration Association.
    4. Severability: If for any reason a court of competent jurisdiction finds any provision of these Terms invalid or unenforceable, that provision of these Terms will be enforced to the maximum extent permissible and the other provisions of these Terms will remain in full force and effect.
    5. Waiver: No modification, addition or deletion or waiver of any rights under this Agreement will be binding on a party unless made in writing, clearly understood by the parties to be a modification or waiver and signed by a duly authorized representative of each party. No failure or delay (in whole or in part) on the part of a party to exercise any right or remedy hereunder will operate as a waiver thereof or effect any other right or remedy. Except as otherwise expressly set forth herein, all rights and remedies hereunder are cumulative and are not exclusive of any other rights or remedies provided hereunder or by law. The waiver of one breach or default or any delay in exercising any rights will not constitute a waiver of any subsequent breach or default.
    6. Notices: Any notice, request, demand or other communication required or permitted to be given under these Terms will be given in writing, will reference these Terms and will be deemed properly given: (a) when actually delivered in person; (b) two (2) business days after deposit with a nationally recognized express courier the day after the date sent by overnight courier; or (c) five (5) business days after mailing via certified mail, postage prepaid. Any such notice, request, demand or other communication will be sent to the Customer address provided upon registration or most recent update provided via the Site in accordance with this Section. Any such notice, request, demand or other communication will be sent to ClinCapture's corporate headquarter in accordance with this Section. Either party may change its address for notices under this Agreement by giving written notice to the other party by the means specified in this Section.
    7. Force Majeure: ClinCapture will not be liable for any failure or delay in its performance under these Terms due to causes beyond its reasonable control, including but not limited to, denial-of-service attacks, labor disputes, strikes, lockouts, shortages of or inability to obtain labor, energy, raw materials or supplies, war, terrorism, riot, act of God or governmental action.
    8. Relationship of Parties: The parties to these Terms are independent contractors and these Terms will not establish any relationship of partnership, joint venture, employment, franchise, or agency between the parties. Neither party will have the power to bind the other or incur obligations on the other's behalf without the other's prior written consent.
    9. Entire Agreement: These Terms and ClinCapture's Privacy Policy constitute the complete understanding and agreement of the parties regarding its subject matter and supersede all prior or contemporaneous agreements or understandings, oral or written, relating to its subject matter. Any waiver, modification or amendment of any provision of these Terms will be effective only if in writing and signed by duly authorized representatives of the parties.
    10. Headings: The headings in these Terms are for the convenience of reference only and have no legal effect.
  12. DEFINITIONS

    "Authorized Access" means an Authorized User's use of the Hosted System in accordance with ClinCapture's terms of service.

    "Authorized User" mean any employee or contractor affiliated with Customer who is authorized in accordance with Section 4.1 to access and use the Hosted System.

    "Customer" refers to organizational entity, but also includes all employees, agents, and independent contractors of Customer.

    "Customer Data" means Customer and/or third-party data, including, without limitation, electronic data capture clinical trial data, uploaded to, stored in, or processed by the Hosted Applications.

    "Hosted Applications" mean the ClinCapture and/or third party software applications utilized on the platform.

    "Hosted System" means, collectively, the Hosted Applications and the Services.

    "Intellectual Property Rights" means patent rights, copyrights, trade secrets, and any other intellectual property rights recognized in any country or jurisdiction in the world.

    "Order form" means ClinCapture's ordering documentation, study agreement, or online sign-up subscription flow that references this agreement.

    "Paid Services" mean additional, subscription-based services.

    "Personal Information" means information that identifies a Customer or Authorized User personally, either alone or in combination with other information means.

    "Potential User" mean any employee or contractor affiliated with Customer who desires to access and use the Hosted System.

    "Services" means the ongoing hosting and management services that ClinCapture will perform to host and manage and enable Customer to access and use the Hosted Applications.

    "Sites" mean a clinical trial site. A clinical trial site is the location where a subject or patient is seen by the Investigator. In ClinCapture the site is used to separate subjects/patients by the Investigator and other staff that have responsibility for the data associated with those subjects/patients. A site can have multiple responsible users but those users assigned to the site will have the same rights, based on their role, to all subjects/patients assigned to that site. Only sites in the production study are counted toward the plan limit.

    "Website" means the www.clincapture.com Website.

  13. PRODUCT TERMS

    The following lists one or more of the Hosted Applications that Customer has signed up for. The descriptions below are for summary understanding purposes only. Some applications and modules may not be available to Customer, depending on which service package Customer has selected.

    • ClinCapture EDC: Access to ClinCapture's role-based Electronic Data Capture (EDC) platform.
    • Data Exports: Exports in a number of formats, including CDISC, ODM, XML, and SPSS, Excel, tab-delimited text, or simply view as HTML.
    • DCF: Electronic Discrepancy Correction Form (DCF) sent to the sites for paper studies.
    • Forms Studio: Drag-and-drop interface where users can quickly design and build their case report forms without any required programming experience.
    • Rules Studio: Drag-and-drop graphical interface to build rules within ClinCapture, such as edit checks, without any required programming or IT expertise.
    • 21 CFR Part 11 Compliant: FDA-validated hosting environment according with the 21 CRF Part 11 compliance requirements, enabling Customers to conform to the necessary regulatory guidelines for a conforming clinical trial.
    • Private Cloud Hosting: Cloud-based virtual environment that is completely isolated and abstracted from the underlying hardware, housed in world-class datacenters.
    • ClinCapture Virtual Update: Monthly online live demonstrations of the latest innovations in the system. Each ClinCapture Virtual Update provides a sneak peek of ClinCapture's roadmap and is followed by a Q&A session.
    • eLearning Tutorials: Online tutorials to learn to enter subjects, schedule events, and manage queries efficiently. Online Tutorials and Quiz split into different modules focusing on different functions: Clinical Data Manager, Medical Coder, Clinical Research Coordinator, Study Monitor, and Principal Investigator.
    • CRF Annotations: CRF field names and variables are automatically annotated and visualized directly on the CRF.
    • Dynamic Groups: In ClinCapture EDC, a dynamic group is associated with specific events. Dynamic groups can be used in conjunction with the randomization function to automatically assign a randomized subject to a dynamic group, as a result of the randomization process.
    • Calendared Visits: Visits automatically scheduled by the system at the completion of a reference visit, typically when the procedure is done.
    • Interactive Dashboards: ClinCapture's Interactive Dashboards are designed to give users an overview of their most essential data directly from ClinCapture's homepage - customizable, drag-and-drop interface which include the status of events, subjects, and discrepancies with direct links from the interface to the data.
    • Item level SDV: Verify the validity of the data entered in CRFs for specific CRF data items.
    • SAS Extracts: Extract data from ClinCapture's EDC and load into SAS datasets.
    • Subject casebook in PDF: Export subject casebooks in PDF format.
    • CDASH CRF Library: A library of ClinCapture standard CRFs in a CDASH format to streamline the process of creating CDISC data from ClinCapture, and to accelerate building new trials through a library of standard CRF ClinCapture forms.
    • CRF Evaluation: Evaluate data and images in the CRF. Includes an additional Evaluator user role in ClinCapture.
    • CRF Masking: Controls whether or not CRFs can be accessible for a specific user.
    • Randomization: ClinCapture features an integrated randomization module that automatically randomizes subjects in different treatment arms.
    • ePRO: Electronic Patient Reported Outcome to collect patient diary data into a central database that integrates seamlessly with ClinCapture.
    • Medical Coding: Features allowing users to code medical terms: ClinCapture supports WHODrug, MedDRA or other standardized codes for medications and adverse events. ClinCapture does not supply any Customer-required medical coding licenses.
    • CDISC SDTM Data Sets: Native support of CDISC SDTM data sets, the clinical data standard for FDA submission and clinical data interoperability.
    • EMR Integration: Integrate ClinCapture seamlessly with an electronic medical record system (EMR).
    • Language Localization: ClinCapture is currently supported in the following languages: English, Russian, Chinese, Spanish and French. We have developed a workflow to localize other languages within a few weeks.
    • Global Hosting Preference: Freedom to house your ClinCapture instance on cloud servers in your geographical region of choice. Also the option to host ClinCapture instance on physical server at SAS70-certified datacenter.
    • CTMS Integration: Selected from a variety of full-featured CTMS applications integrated for use on and with the ClinCapture platform.
    • Web Services API: Programmatic interface to exchange data in real time.
  14. CONDITIONS OF USE, POLICIES, AND REVISIONS

    By registering for our Website, your visit and any dispute over privacy is subject to these Terms and our Privacy Policy, including limitations on damages, resolution of disputes, and application of the law of the state of California.

    Our company is constantly evolving, as are our Terms and our Privacy Policy. As we provide more services on our Website and as privacy laws and regulations change, it may be necessary to revise or update our Terms without notice, but we will post those changes on our Website's home page so our users are aware of what has been updated.

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