Services
NN Translations supports the migration of validated Clinical Outcome Assessments (COAs) from paper-based or other source formats to electronic platforms while helping preserve their conceptual equivalence, content integrity, intended meaning and usability.
As part of our eCOA implementation process, we work with the clinical trial sponsor's selected eCOA provider or, where required, coordinate with an experienced eCOA partner.
Workflow
We coordinate with clinical trial sponsors, CROs, COA licensing companies, instrument developers, copyright holders and eCOA providers to confirm licensing conditions, approved source and language versions and language requirements before eCOA migration begins.
Our workflow is adapted to the instrument, target population, device, electronic platform, mode of administration and requirements of the instrument developer or copyright holder. It is informed by recognised industry good practices for the electronic implementation of COAs, including recommendations developed by the Critical Path Institute's eCOA Consortium and ISPOR.
Implementation
Within eCOA implementation, NN Translations supports the linguistic and content-related activities required to transfer validated COAs to electronic platforms. We coordinate migration review and Screenshot Review with the sponsor's selected eCOA provider, helping maintain continuity between the approved source content, validated translations and their electronic implementation.
The eCOA provider remains responsible for platform configuration, technical implementation, system validation, UAT support and production deployment.
We compare the migrated content against the approved source and validated language versions, reviewing:
instructions, items and response options;
authorised wording and formatting adaptations;
dynamic fields, tags and placeholders; and
consistency across languages and modes of administration.
Once the eCOA provider has configured the instrument, our in-country specialists review screenshots or test screens for:
missing, incorrect or truncated text;
formatting, spacing and line-break issues;
response-option and navigation consistency;
incorrect characters, accents or punctuation; and
display issues affecting meaning or usability.
Comments and corrections are documented and coordinated with the eCOA provider until the identified linguistic issues are resolved.
Integrity
Our objective is to help preserve the conceptual equivalence, content integrity and usability of the validated COA when implemented electronically. This provides clinical trial sponsors and eCOA providers with a documented linguistic review process, supports reliable implementation across languages and study populations, and helps protect the comparability of clinical outcome data collected across languages and modes of administration.
Resources
Access practical guidance, insights and supporting materials for COA licensing, Linguistic Validation, COA/eCOA projects.
Questions
When should eCOA migration planning begin?
eCOA migration should be considered early in study planning so that the intended mode of administration, platform requirements, COA licensing requirements, and any copyright holder or instrument developer requirements for electronic implementation can be identified before migration begins.
Do you work with our selected eCOA provider?
Yes. We can work directly with the sponsor's selected eCOA provider and coordinate the migration and review process. Where an eCOA provider has not yet been selected, we can coordinate implementation through our trusted network of experienced eCOA partners.
What is an eCOA migration review?
Migration review compares the electronically implemented content against the approved source and validated language versions to identify potential discrepancies in wording, response options, instructions, formatting, dynamic content and other elements that could affect the integrity of the COA.
What is Screenshot Review (SSR)?
Screenshot Review is the linguistic review of the instrument after it has been configured on the electronic platform. In-country specialists review the displayed content for missing or truncated text, incorrect characters, formatting and line-break issues, response option consistency and other display issues that may affect meaning or usability.
Can you support the process from Linguistic Validation through eCOA implementation?
Yes. We can manage Linguistic Validation and subsequently coordinate eCOA migration and review with the selected eCOA provider, helping maintain continuity between the validated translations and their electronic implementation.
Contact us to discuss your instrument, target languages, selected eCOA platform and planned implementation timeline.