SmartSignals Advisory

Scale Management

Quality COAs to produce reliable results

Utilize high quality COAs to generate accurate evidence 

  • Apply studyappropriate COAs
    Clinical science experts identify, recommend, and obtain appropriate COA versions and translations to address sponsors’ clinical objectives. 
  • Reduce study startup lead time
    Rely on an experienced team with active relationships with copyright holders to efficiently acquire instruments on your behalf. 
  • Minimize errors
    Questionnaires adapted for eCOA will undergo a careful process in collaboration with copyright owners to validate electronic versions of COAs. 

How will your study benefit?

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 Clinical Science Team will recommend appropriate COAs and versions for your study based upon the therapeutic area, indication, and requirements of your protocol.

 

  • Licensing & Acquisition – Our Scale Management Team will determine who owns the copyright and identify commercially available translations. COA owners can be individuals or they can be large commercial entities operating on behalf of copyright holdersTracking down those owners, negotiating costs and licensing, and obtaining scale source documents from owners can be complicated and time consuming. Let our team leverage extensive experience and established collaborative partnerships with COA owners to navigate and document this complex process for you.    
  • Translation – Translations can take time to complete and certify, time that sponsors can utilize attending to more pressing prioritiesIn addition, different copyright holders may have different translation requirements to produce culturally valid versions in new languages. Signant’s Localization Team will handle the process from start to finish, expertly initiating and completing translations and linguistic validation, obtaining copyright holder approvals, and providing sponsors with final versions of translated COAs with corresponding certificates of translation (COTs).

 

  • Electronic migration – Migrating validated instruments from paper to electronic versions can require minor adaptations to language and instructional text to be appropriate in an electronic modality.  Our team manage 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 COAs, we create source documents, distribute the COAs to sites/sponsors for study use, or adapt the COA for deployment via an eCOA device 

Frequently Asked Questions

What is scale management for clinical trial development?

Scale management in clinical trials refers to the selection, acquisition, and application of questionnaires and instruments used to measure clinical outcomes.

What is the lead time required for Signant to acquire licenses on behalf of a sponsor?

The lead time to acquire licenses for a sponsor varies by the complexity. It can range from 2 to 4 weeks prior to the Kick-off Meeting.

Does Signant pay invoices on behalf of sponsors?

Signant signs contracts and pays invoices on behalf of sponsors in order to reduce burden and shorten lead time during up-front clinical trial phases. In rare cases, a Copyright Holder may require a sponsor’s signature. In these instances, Signant handles all other aspects before facilitating the sponsor signature.

Does Scale Management lead time include new translations, if they are required?

Scale Management lead time includes licensing and acquisition of English master versions and any commercially available translations. Should new translations need to be developed, this is coordinated between the sponsor’s study team and Signant’s project team based on language prioritization and translations.

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