ePROs are increasingly used in global clinical trials. We certify that the content of the translation displayed on the electronic device (i.e. the ePRO translation) is:
Error-free and displays correctly on the screen (no missing characters, etc.)
Consistent with the original ePRO
Consistent with the paper-administered translation, developed through the linguistic validation process (no alteration in wording)
Our services include:
- The conversion of the paper-administered versions to e-administered versions, and
- The development and creation of e-administered versions, combined with a linguistic-validation process.
Licensing and Copyright Management
To facilitate the project management of the Linguistic Validation process, we offer our clients two types of services: Copyright Management and Licensing Agreements with developers/owners of measures.
Thanks to our privileged contacts with developers and copyright holders, we can take on the entire administrative burden of negotiating permission to translate and use of translated measures in clinical trials.
We provide our clients with the peace of mind of knowing that copyright laws are complied with.
In addition, we have developed a set of recommendations about copyrights for users and developers of measures. See here.
In addition to our Linguistic Validation service we offer a full range of medical-translation services. We are specialists in translating : training material, user manuals, marketing materials, and study-specific documents related to the use of PROs and ClinROs in clinical trials (cover letter to patients, instructions to clinicians, and texts).
We provide translations formatted according to our clients’ CRF templates.
We use the source instruments integrated into our clients’ CRF templates as the master versions for formatting the translations.
Each translation is created from the original master version in alignment with our clients’ requirements:
- Duplication of the requested number of visits (if needed)
- Quality control: checking of the formatted translations including: (1) Correspondence between translation and original (no missing sentences); (2) Numbering of questions and response choices identical to the original; (3) Typography (bold type, italic type, underlined text, etc.), drawings and figures identical to the original; (4) Headers and footers identical to the source English template
The final translations can be provided in a variety of formats including MS Word, PDF, PageMaker, InDesign or any other specific data collection package that is required.
Communicating about the results of cross-cultural clinical research is crucial. The ultimate goal and rationale for this service is to enhance the wide recognition and credibility of information generated from application of linguistically validated versions by the scientific community (particularly experts in the field), researchers, policymakers, and the wider audience.
We can provide our clients with support for writing abstracts, posters, presentations and scientific manuscripts.