Validated
from first translation
to signed certificate.Linguistic Validation for Clinical Outcome Assessments
Since 2010 I have managed the full linguistic validation workflow for clinical outcome assessments in Bulgarian and across all national languages. Every step is documented under my Full-Trace Validation Protocol™, which is auditable and ready for regulatory submission.
Who you work with
My name is Vladka Sokolova, and I personally manage every project on this site. My name and my credentials are attached to your validation record: European Master's in Translation, ProZ.com Certified PRO, linguistic validation work since 2010.
When you work with an agency, accountability dissolves across a production chain. When you work with me, you work with one person you can always reach. If something needs an answer, I answer personally in writing and usually within hours.
I manage every step personally – sourcing and briefing translators, reviewing back-translations, coordinating debriefing interviews, writing TQA reports. There are no handoffs or miscommunications between departments.
I have worked with PRO instruments across 15+ therapeutic areas. I am aware what regulators expect. I also know where validation processes typically go wrong – and I prevent this before it happens.
Full pricing is published here. I conduct no discovery calls, and there are no opaque agency margins. You submit a written brief and receive a written estimate within 24 hours. A firm, itemized proposal follows once the instrument and project details are received. All my work comes with a Lifetime Rework Guarantee.
Selected validated instruments
A portfolio built since 2010 across therapeutic areas – full linguistic validation, back-translation review, and cognitive debriefing coordination.
- –Rheumatoid Arthritis Impact of Disease (RAID)
- –Morning Stiffness Visual Analogue Scale
- –Health Assessment Questionnaire (HAQ-DI · HAQ-VAS)
- –RA Work Productivity Survey (WPS-RA)
- –Subject's Global Assessment of Disease Activity VAS
- –Cancer Dyspnoea Scale
- –MDASI Core Items
- –MDASI – CLL Variant
- –EORTC Chronic Lymphocytic Leukaemia (CLL)
- –Data Prompts for Cancer Patients Experiencing Pain
- –Emesis Patient Diary
- –Nausea & Vomiting Subject Diary
- –Short-Form McGill Pain Questionnaire-2
- –Point Numerical Pain Rating Scale
- –Diabetes Assessment of Blood Sugar (D-ABS)
- –Diabetes Management Impact Questionnaire (D-MIQ)
- –Treatment Related Impact Measure – Hypoglycaemic Events (TRIM-HYPO)
- –IBS Quality of Life (IBS-QOL)
- –Functional Dyspepsia Questionnaire
- –Infant GI Symptom Questionnaire (IGSQ-13)
- –Crohn's Disease PRO (US0494084)
- –Neurological Fatigue Index – MS (NFI-MS)
- –FACIT Fatigue Scale
- –Urine Volume Chart (UVC)
- –Patient Symptom Assessment – Urinary Tract Infection
- –PedsQL Infant Scales
- –Food Allergy Quality of Life – Parental Burden (FAQL-PB)
- –Atopic Dermatitis Questionnaire
- –Swallowing Ability Questionnaire
- –Food Craving Inventory-II for Schizophrenia Patients
- –Oxford Hip Score (OHS)
- –Oxford Knee Score (OKS)
- –Informed consents (approx. 70,000 words)
- –Patient & physician materials
- –Trial progress reports
- –Clinical trial audio prompts
- –SF-36v2 Standard Version
- –Health Change Questionnaire
- –Bond Lader Visual Analogue Scale
Full project details and target languages available upon request under NDA.
All national languages – personally managed
I source, brief, and oversee specialist translators and in-country professionals across all European and major world languages.
The Full-Trace Validation Protocol™
Every linguistic decision in your validation project exists in writing – timestamped, attributable, and audit-ready.
Review of the source instrument, concepts, available reference material and project requirements before translation begins.
Two independent specialist translators produce separate forward translations of the instrument.
The two forward translations are compared and reconciled into one Target Version 1, with translation decisions and rationale documented.
A separate specialist produces a blinded back translation of Target Version 1 without access to the original source wording.
The back translation is compared with the source to identify possible shifts in meaning, terminology or conceptual equivalence, with findings documented in the Translation Quality Assessment.
In-country patient recruitment and interview coordination. Feedback on clarity, understanding and cultural relevance is documented and analysed.
Feedback from cognitive debriefing and other agreed review stages is assessed and incorporated where appropriate into Target Version 2.
A clinician or relevant subject specialist reviews terminology and content when specialist clinical review is required for the project.
The agreed final version and project documentation are completed, and a signed Linguistic Validation Certificate is issued.
What the validation record looks like
This anonymised sample shows how source review, independent forward translations, reconciliation, blind back-translation, cognitive debriefing when required, clinician review when required and final validation documentation are recorded across a project.
Every completed validation is accompanied by a signed LV Certificate suitable for regulatory submission – something most project managers do not provide as standard. I officially stand behind every certificate with my own work, name and expertise.
The Lifetime Rework Guarantee
Since 2010, no validation documentation I have delivered has ever been rejected or returned by a regulatory reviewer, an ethics committee, or a sponsor's QA.
I intend to keep it that way, so the guarantee covers the unlikely event that any deliverable from your project is challenged on linguistic-validation grounds. In such instances, I will offer further clarifications or rework where needed, at no cost and for as long as it takes. There is no time limit and no small print.
I can offer this because the Full-Trace Validation Protocol™ leaves nothing undocumented, so every question already has an answer.
Personal management has a natural limit and I would rather state it than exceed it.
I accept up to 15 target languages in any three-month window for projects starting immediately. If you contact me at least four weeks before your intended start, I can reserve extended capacity – up to 25 languages per quarter, across no more than three client projects.
Once the quarter's capacity is booked, new projects go to the next start date. I don't stretch the limit, because the limit is what protects quality.
Estimate your project
Word count refers to the total source text of all instruments combined, per language. All projects are paid in full upfront.
Timelines are indicative and apply to standard projects of up to 5 languages. For projects of 6 or more languages, the exact timeline is confirmed in the written proposal. Timelines may extend by two weeks if the project coincides with holiday periods (Christmas/New Year/Easter, or summer months) due to limited availability of in-country specialists.
All prices in EUR, exclusive of VAT · Includes the agreed workflow through final validation documentation and signed LV Certificate · Conditional stages are included where required by the agreed project scope · Written estimate within 24 hours for Tier XL and non-European languages; a firm, itemized proposal follows once the instrument and project details are received · No work on weekends or public holidays
Written estimate within 24 hours
Submit your project brief and receive a written estimate within 24 hours. A firm, itemized proposal follows once the instrument and project details are received. There are no calls required at any stage and every communication is carried out in writing, fully auditable.
Ready to begin?
Submit a written brief. Receive a written estimate within 24 hours. A firm, itemized proposal follows once the instrument and project details are received. No commitment until you approve in writing.