I am able to provide you with a full range of linguistic services. These are described in detail below.
I am also happy to discuss any work which involves a combination of these services
or which is more unique in nature.
Specialized translation, editing & proofreading
Accurate and compliant texts
I offer translation, editing and proofreading services, applying in-depth linguistic and technical knowledge to provide rigorous and compliant translations.
The final text is adapted to the specific purpose and audience,
follows national and international regulatory requirements
(e.g., EMA templates and guidelines) and use the correct
terminology (medDRA and EDQM).
All texts are translated using the most recent technology, namely translation memories, terminology management, and quality assurance tools, in order to guarantee accurate and consistent translations.
The editing and proofreading steps include the implementation of thorough quality control for all aspects related to terminology and coherence (editing), formatting, grammar, and spelling (proofreading).
Validation of Clinical Outcome Assessments
Linguistic validation and eCOA integration
I provide the translation and linguistic validation of Clinical Outcome Assessments (COAs), to ensure the reliability, conceptual equivalence, and content validity of questionnaires, scales and other tools which have been translated into the target language.
The process of linguistic validation may involve multiple steps,
which may include: translation, back-translation, cognitive debriefing (interviews with patients or healthy subjects), technical review (performed by a clinician in cooperation with the language consultant), and proofreading.
I also perform eCOA integration, which consists of the migration of previously validated tools from paper into electronic formats to be used in VR, web applications, tablets and smartphones.
Types of Clinical Outcome Assessments (COAs): Patient-Reported Outcomes (PROs); Observer-Reported Outcomes (ObsROs); Clinician-Reported Outcomes (ClinROs); and Performance Outcomes (motor, sensory, cognition).