The Evidens™ solutions1,2

Real-world evidence (RWE) is becoming increasingly important for regulatory decision-making and is beginning to permeate all areas of the healthcare value chain.

RWE is now beginning to be used to support clinical trial design and to generate better treatment approaches, while healthcare systems are collecting and using RWE to substantiate coverage decisions.

RWE has the potential to transform the healthcare ecosystem in an effective and efficient way from which all actors would benefit.

Therefore, there is a need for options that allow for a broader and less restricted collection of data.

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1. FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM. December 2018. FDA US Drug and food administration. Available on https://www.fda.gov/media/120060/download 

2. Khosla S, et al. Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation? [version 2; referees: 2 approved] F1000Research 2018, 7:1

Evidens™ benefits

Evidens™ provides healthcare organisations with a fully customisable, secured, and user-friendly platform for collecting high-quality data that can contribute to the generation of real-world evidence and improvement of stakeholder outcomes.

  • Free: the tool is provided under a royalty free license agreement
  • Secure: highest IT security protocols
  • User-friendly: fully intuitive platform accessible online and offline as needed

For healthcare organisations such as, but not limited to:

  • Public and private hospitals
  • Clinics
  • Patient groups
  • Regulatory bodies
  • Not-for-profit healthcare organisations

Fully customisable ready-to-use platform: we offer the right solution for your needs.

Independent.

Although Evidens™ solutions have been developed by Roche, the royalty-free license agreement is not contingent on the purchase, supply or recommendation of any Roche products and Roche has no influence on the data collection. Evidens™ solutions are intended to enhance patient care and/or to benefit public health.

Frequently Asked Questions

  • To whom are the Evidens™ solutions addressed?

    The Evidens™ solutions are designed for healthcare organisations, which include but are not limited to public institutions, universities (academy), patient organisations, regulatory authorities, hospitals, clinics, etc.

  • Who do I sign the agreement with?

    The agreement will be signed between F. Hoffmann-La Roche Ltd and your party.

  • Who is the owner of the software?

    The RECIPIENT has no proprietary rights in and to the SOFTWARE. The RECIPIENT acknowledges and agrees that Roche retains all copyrights and other proprietary rights in and to the SOFTWARE. Use within the scope of this license is free of charge and no royalty or licensing fees are paid by the RECIPIENT.

     

    In case of EVIDENS™, the data elements included in the tool according to the RECIPIENT’s own need belong to the RECIPIENT and will not be shared without the prior written consent of the RECIPIENT and will be deleted from Roche server maximum 6 months following the delivery of the SOFTWARE.

     

    For CLARUM and REVELA, the full configuration including the data elements belongs to Roche.

  • Where is the data stored?

    The data can be stored on your server or in the cloud, according to your preferences.

  • Where will the software be hosted?

    A minimum part of the software should be installed on the recipient's server. Anything else can be cloud-based. If the recipient does not own a server, please contact us for further support.

  • Who owns the data?

    The recipient is the owner of the data (the data controller). The data controller is the decision maker regarding with whom the data is shared. Roche has no rights to the data unless there is a data-sharing agreement in place.

  • Who has access to the data?

    Administrators have access to the pseudonymised data set (without access to private data) of all patients included in the platform. Users responsible for the data entry such as physicians can extract data from their own patients only (including private data). Patients do not have access to data.

  • In which format can the data be extracted?

    The data is extracted in a pseudonymised manner, using the reporting section of the software, and a CSV file is obtained.

  • Who is accountable for the informed consent?

    Where applicable in accordance with local regulations, the users are responsible for collecting and storing the informed consents. Informed consents can be uploaded in the tools.

  • Is it possible to link the Evidens™ solutions to pre-existing systems (EHR)?

    Yes, it is possible. Evidens™ solutions (Evidens™, Clarum and Revela) offer interoperability between systems. However, this should be highlighted during the configuration phase.

  • What kind of analysis is performed automatically by the tool?

    The tool offers simple statistical features, like auto-calculate percentage, median, and showing data in a pie chart, but it is not meant for extensive analysis. However, the data can be extracted and used with any other data analysis system.

  • Will it be possible to collect retrospective data?

    This depends on the purpose of the tool. You, as the recipient, will collect the data according to your needs.

  • Who is responsible for maintaining the software?

    Once an Evidens™ solution is dispatched, it is up to the recipient to maintain the software.

Our Partnerships

“The pre-configuration and the simplicity of the administrator module to be able to add, move or delete variables allowing their adaptation to the registry objectives without the participation of experts or of Roche itself grants a very important independence and flexibility.”

Administrator, Clarum COVID-19 in Argentina

 

Experience Evidens™

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