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Managing the in-country clinical and linguistic reviews has become one of the key elements of an efficient translation process. Over the years, Moravia has built and trained a unique network of in-country clinical professionals, practitioners and reviewers, for a wide range of therapeutic areas and languages.

As part of our process, we provide two types of independent in-country reviews that complement the standard translation editing and proofreading steps.

  • Clinical reviews are carried out by medical professionals and practitioners, who have the practical experience in the therapeutic area in the given country. This means they can assess with authority the accuracy and usability of the text in the local context, for the specified use, and how it complies with the local practices and context.
  • Linguistic reviews are conducted by our qualified linguists who specialize in Life Sciences, and who ensure the language, stylistic and terminological correctness and consistency of the translated material.

Moravia offers Linguistic Validation services for Patient-Reported Outcomes in accordance with the guidelines developed and provided by the FDA and ISPOR, followed by a complete report.

Managing the Review Processes

Managing the implementation of changes from reviews is an equally important part of the process, given the regulated nature of the industry. Moravia's language leads assess the proposed changes in terms of how they comply with the client's general and project-specific guidelines and they work with the client to resolve any discrepancies and record and document their resolution.

The final result is a comprehensive report documenting the linguistic process and the language decisions made during the entire process.

We normally manage in-country reviews using our network, however, we have also won the trust of our clients to communicate with and manage their own medical reviewers. In this model, we ensure a smooth inclusion of the review process in the overall translation workflow, which helps to increase its efficiency, and typically reduces the time and costs required for managing the process and the clients' associated internal overhead.

Cognitive debriefing (pilot testing) continues to play an important role in ensuring the language quality of patient-reported outcomes. At Moravia, we understand and follow the guidelines set by the ISPOR Task Force for Translation and Cultural Adaptation, titled Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures.

To learn more about our linguistic validation services, please complete the Request for Information form and we will get back to you shortly, or see other options for contacting us.