01 / DISCIPLINE

Linguistic Validation & Clinical Outcome Assessments

I have specialized in Linguistic Validation since 2008 and have contributed to more than 1,000 projects involving Clinical Outcome Assessments across a wide range of therapeutic areas and patient populations.

My experience spans PRO, ObsRO, ClinRO and PerfO measures and multiple stages of the Linguistic Validation process, including forward translation, reconciliation, back-translation review, harmonization, Cognitive Debriefing, Clinician Review, linguistic review and finalisation. But Linguistic Validation is more than a sequence of predefined steps.

Much of the expertise lies in the decisions made within them: recognizing when a linguistically natural solution subtly shifts a concept, when apparently equivalent wording changes intensity, attribution or scope, or when a small grammatical choice may influence the way a respondent interprets an item. Concept definitions and Lists of Concepts provide an essential anchor for these decisions, particularly when several translations are linguistically possible but not conceptually interchangeable.

The aim is not to reproduce the same words across languages. It is to preserve the intended concept and the way the instrument is intended to function.

02 / DISCIPLINE

Cognitive Debriefing & Participant Recruitment

Cognitive Debriefing asks a deceptively simple question: Does the respondent understand the item as it was intended to be understood?

The answer cannot always be obtained by asking whether something is “clear”.

A respondent may understand every individual word and still interpret the item differently from what was intended. Cognitive Debriefing therefore explores how respondents arrive at their understanding: what they think a question is asking, how they interpret key concepts, what they include or exclude when responding, and how they understand response options, instructions and recall periods.

My experience covers the process from participant recruitment to interviewing, analysis and reporting. I conduct Cognitive Debriefing interviews across different age groups and patient populations, probe areas of potential difficulty, analyze respondent feedback and document findings for subsequent stages of the Linguistic Validation process.

For me, this is one of the most valuable parts of Linguistic Validation: the point at which assumptions about language meet the way real people actually understand it.

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03 / DISCIPLINE

Clinician Review & Recruitment

Clinician Review brings specialist clinical expertise into the Linguistic Validation process, particularly where terminology, clinical relevance and the interpretation of concepts in clinical practice require expert assessment.

Over many years of working in Linguistic Validation, I have built an established network of clinicians across multiple medical specialties and recruit appropriate specialists according to the therapeutic area and requirements of each project.

My involvement extends throughout the Clinician Review process — from identifying and recruiting the appropriate clinician and coordinating the review to evaluating, reconciling and implementing clinician feedback. This also includes resolving queries where linguistic, conceptual and clinical considerations need to be balanced.

A clinician’s recommendation is an important source of expert evidence, but it does not exist in isolation. A proposed change must also be considered against the source text, concept definition, target-language usage and the intended function of the instrument.

The value of Clinician Review therefore lies not simply in obtaining clinical approval, but in bringing clinical, linguistic and conceptual expertise into dialogue.

04 / DISCIPLINE

eCOA Adaptation & Migration

I adapt and migrate Clinical Outcome Assessments from paper to electronic modes of administration.

Working from the approved paper version and the project-specific Mapping Sheet, I transfer and adapt the target-language content directly within eCOA systems, applying the required mode-specific wording and ensuring consistency with the approved instrument.

Paper-to-electronic migration is not simply a matter of reproducing existing text on a screen. Instructions and other interface-dependent wording may need to be adapted to reflect the way respondents interact with the electronic version, while preserving the intended concept and avoiding unnecessary changes to validated content.

Once the electronic version has been implemented, I perform detailed screenshot checks against the approved materials and Mapping Sheet, identifying linguistic, formatting and implementation discrepancies and documenting the required corrections.

The review continues through as many rounds as necessary until the electronic implementation is linguistically accurate, internally consistent and ready for finalisation.

This work requires meticulous attention to detail: even a seemingly minor discrepancy in wording, response options, instructions or screen implementation can affect the integrity of the instrument.

05 / DISCIPLINE

Life Sciences & Clinical Research Translation & Review

I provide specialized English–Czech translation and linguistic review for clinical research and medical communication, with extensive experience in clinical trial documentation and patient-facing materials.

My work includes both translation and independent linguistic review across clinical trial documentation, informed consent and patient information materials, medical and pharmaceutical content, and materials supporting Clinical Outcome Assessment research.

Revision requires a different kind of attention from translation. The task is not to rewrite a text according to personal preference, but to identify changes that genuinely improve accuracy, clarity, consistency or suitability for the intended audience — while recognizing when an existing solution is already appropriate.

In patient-facing materials, this often means balancing medical accuracy with clear, appropriate language for the people who will actually read and use the material.

06 / DISCIPLINE

Latin & Classical Languages

My academic background is in Classical Philology, with a Master’s degree in Latin and Classical Greek Language and Literature.

My training involved extensive work with Latin and Classical Greek grammar, syntax, stylistics, textual interpretation and translation.

Latin

I provide specialist linguistic services involving Latin, including linguistic review, source-to-target comparison, translation and textual and linguistic analysis.

Translation into Latin, particularly of modern content, presents a specific set of challenges. Many contemporary concepts, institutions and communicative conventions developed outside the historical contexts in which Latin was used. Working with modern content may therefore require deliberate decisions about register, period, terminology and the appropriate use of Neo-Latin solutions.

For this reason, I approach work involving Latin not simply as lexical transfer, but as a question of linguistic, historical and contextual appropriateness.

Classical Greek

Specialist consultation involving Classical Greek is available for projects requiring access to the original language, including questions of meaning, grammar, terminology, etymology and textual interpretation.

07 / DISCIPLINE

Sworn Translation

I am a sworn translator for English and Latin under Czech law.

I provide sworn translations between English, Czech and Latin for legal, administrative, academic and other official purposes.

Sworn translations are available in both traditional paper and electronic form, with electronic sworn translations issued and delivered in accordance with applicable Czech requirements.