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