The customisable digital solution for the collection of real-world data in the context of a disease registry.

The Clarum Vision

Patient registries can unlock valuable scientific insights. They can close the gaps from clinical studies and bring scientific evidence on treatments, diseases, guidelines, and budget planning in real-world settings with a broad patient population.

 

However, it is not always simple for a healthcare organisation to create and securely collect such registries.

 

The Clarum vision is to help you harness the power of registries and real-world evidence through an intuitive digital solution that enables you to create and collect registries in real-life settings both rapidly and securely.

What is Clarum?

Clarum is a fully configurable web-based software solution designed for the secure and intuitive collection of real-world any disease area.

    • Online or offline accessibility from any device type (computers, tablets, smartphones) makes usage convenient
    • User-friendly interfaces make data capture easy for all user profiles
    • API management and inter-operability standards facilitate data capture across institutions and geographies
    • Alignment with the most recent data privacy requirements and validation ensure full data security
      • Pre-configured templates using common data elements are available for rapid, cost-effective setup and ensure uniform data capture across sites and countries
      • Run queries missing data (administrator role)
      • Pseudonomized data aggregation and export (administrator role) supported by consent form enable convenient, compliant RWE analysis

      Clarum consist of three modules each with different functionalities:

      Administrator

      • Configure the registry (process supported by Roche)
      • Access the entire data set
      • Extract pseudonymised data from the registry
      • Analyse data for publishing in scientific journals

       

      User/data entry

      • Obtain and manage patient consent
      • Collect and enter patient data
      • Run statistics and queries for their own patients

      Patient

      • Provide consent to data collection
      • Answer questionnaires directly in the tool

      How can the data be used?

      Data collected through Clarum in a real-world setting is most valuable for providing real-life that can be used:

      • Assess treatment effectiveness
      • Assess treatment safety
      • Support early access to and reimbursement of innovative medicines
      • Monitor patient performance and compare data across therapeutic areas and sites
      • Collect meaningful data sets for rare conditions
      • Publish retrospective RWE in scientific journals

      How can you access Clarum?

      Ready to make a start?

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      Clarum technical requirements

      Hardware requirements:

      • Minimum requirements: a server with 2 CPU, 8Gb of RAM
      • At least 20 GB of free disk space is recommended.
      • 500 MB free capacity (excluding Node.js and MongoDB)
      • Additional space is recommended for database and user attachments.
         

      Software requirements:

      • Operating system: Unix (any distribution)
      • Prerequisites:
        • Node.js installed
        • MongoDB installed
        • SMTP service for sending emails to users
        • SSL certificate for the domain


      Web browser (all the following are supported):

      • Google Chrome
      • Mozilla Firefox
      • Apple Safari
      • iOS Safari
      • Android Chrome

      Why Clarum?

      High-quality real-world data and real-world evidence is needed to support healthcare decision making

      Awareness is growing of the limitations of randomised clinical trials (RCTs):

      • Few patients take part in clinical trials, making detection of rare treatment effects difficult2
      • RCT populations rarely reflect “real world” populations and occur within a limited time frame3
      • RCTs may not be generating evidence on endpoints useful to patients, providers, or payers2
      • Not always ethical to have patients on placebo or not enough patients to sufficiently power a trial4
      • A multitude of questions remain unanswered at the time of regulatory approval2

      New opportunities are being created for RWE via new data sources:

      Growth of wearable technology, sensors, and social media

      Availability of highly sophisticated electronic tools, including artificial intelligence, to access, analyse and link data sources

      • Availability of highly sophisticated electronic tools, including artificial intelligence, to access, analyse and link data sources

      Nowadays, regulatory authorities are increasingly relying on RWE and RWD to support decision-making. Both the FDA and EMA have issued guidance documents to organise the set-up and use of effective patient registries.

      2.    Cohen AT, et al. Why do we need observational studies of everyday patients in the real-life setting?, European Heart Journal Supplements. July 2015;17(suppl_D):D2–D8.

      3.    Sherman RE, et al. Real-World Evidence - What Is It and What Can It Tell Us?. N Engl J Med. 2016;375(23):2293-2297.

      4.    Sanson-Fisher RW, et al. Limitations of the randomized controlled trial in evaluating population-based health interventions. Am J Prev Med. 2007;33(2):155-161.

      Clarum Case Studies

      Clarum COVID-19 Argentina

      With 51 participating institutions nationwide, Clarum COVID-19 is being used in Argentina to better understand this new disease, including its behaviour, the burden of disease, risk levels to different groups, and the effectiveness of local guidelines.

      “Clarum was ready to be used and quickly delivered with a quite comprehensive data dictionary.”

      Administrator, Clarum COVID-19 in Argentina

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