SmartSignals Advisory

Scale Management

Quality tools to produce reliable results 

Importance of appropriate scales & questionnaires

Selecting appropriate scales and instruments to meet the measurement objectives of clinical trials is a vital aspect of protocol development. Once selected, efficiently navigating the licensing, validation, testing, and translation processes for each scale is important to ensure your instruments are applied correctly and implemented on time. Errors in this process could invalidate the data you collect.

Signant Health’s dedicated scale management and clinical science teams take a multi-phase approach to this important process, assuring sponsors that the appropriate questionnaire is selected, translated, and applied correctly.

 

Select and implement study-appropriate scales

Each phase in Signant Health’s scale management process eliminates the common challenges that put studies at risk if not done properly, reduces workloads for sponsors and sites, and improves the quality and reliability of data produced during a study. Our comprehensive end-to-end process entails: 

  • Identification
    Our team will recommend appropriate clinical outcome assessment scales and versions, identify owners, and determine what translations are commercially available.

 

  • Licensing & acquisition
    Scale owners can be individuals or they can be large commercial entities operating on behalf of copyright holders. Tracking down instrument owners, negotiating costs and licensing as well as obtaining scale source documents from owners can be complicated and time consuming. Let our experienced team leverage our established collaborative partnerships with scale owners to navigate and document this complex process for you.
  • Translation
    Translations can take time to complete and certify. Scale owners may have translation requirements to produce culturally valid versions in new languages. Signant’s scale management team will handle the process from start to finish. We initiate and complete scale translations, obtain instrument owner approvals, and provide sponsors with final versions of translated scales with corresponding certificates of translation.

 

  • Electronic migration
    Migrating validated instruments from paper to electronic versions requires minor adaptations to language and instructional text to be appropriate in an electronic modality. Our team manages the associated translations processes to migrate from paper to electronic formats while carefully maintaining instrument measurement properties.

 

  • Fulfillment & distribution of paper scales
    While most of our work supports the electronic implementation of clinical outcome assessments, our scale management team can also support your study if you are collecting these data on paper. As the final step in developing study-appropriate instruments and scales intended for pen and paper completion, we perform multiple quality control checks and then distribute scales to sites/sponsors for study use.

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