UlatusMedical Translation ServicesLinguistic Validation Services
Linguistic Validation

Linguistic Validation Service

Meet the regulatory requirements for successfully clearing COA by following FDA & ISPOR procedures

Johnson & Johnson
Pfizer
Sanofi
Medable
Encompass
Siemens Healthineers
Novotech

Linguistic Validation Service that leaves no room for errors in the launch of your clinical trial.

Linguistic validation is vital in multinational clinical trials. Ulatus' clinical expertise ensures seamless adaptation of sensitive content across languages and cultures. We help meet stringent standards for Clinical Outcome Assessment (COA) validation, following FDA and ISPOR procedures. Our commitment ensures conceptual, cultural, and constructive equivalence in all targeted languages.

Some of the Documents that require Linguistic Validation

  • Training Materials
  • Clinical Trial Documents
  • Healthcare Questionnaires and Forms
  • Regulatory Documents
  • Medical Device Instructions
  • Pharmaceutical Labels and Packaging
  • Educational Materials
  • Patient-Reported Outcome (PRO) Instruments
200+

Languages

2B+

Words Translated

3000+

Expert Linguists

20+

Years of Excellence

99.4%

Client Satisfaction

200K+

Clients Worldwide

Therapeutic Areas of Expertise

Our team comprises field specialists dedicated to your subject and therapeutic area, ensuring the utmost quality.

OncologyOncology
NeurologyNeurology
CardiologyCardiology
RheumatologyRheumatology
EndocrinologyEndocrinology
PediatricsPediatrics
Rare DiseasesRare Diseases
Infectious DiseasesInfectious Diseases
GastroenterologyGastroenterology
Respiratory MedicineRespiratory Medicine
DermatologyDermatology
Women's HealthWomen's Health
Psychiatry and Mental HealthPsychiatry and Mental Health
Background

Why Select Ulatus for your COA Translations

We've designed our localization experience with certified processes and efficient technology, ensuring a seamless delivery of consistent quality that enhances client satisfaction.

Specialized Subject-Area Matching

Quality-Driven Technology

24x7 Dedicated Localization Manager

ROI-Driven Localization Solutions

In-House Expertise

ISO-Certified Processes

Certified processes that ensure superior quality of translated outcomes

Recognizing the significance of quality, we are committed to providing services that consistently meet the highest standards of excellence.

Preparation
1

Preparation

Recruit key in-country persons for the project

Forward Translation
2

Forward Translation

Development of at least two independent forward translations

Reconciliation
3

Reconciliation

Reconciliation of the forward translations into a single forward translation

Back Translation
4

Back Translation

Back translation of the reconciled translation into the source language

Back Translation Review
5

Back Translation Review

Review of the back translations against the source language

Harmonization
6

Harmonization

Harmonization of all new translations with each other and the source version

Cognitive Debriefing
7

Cognitive Debriefing

Cognitive debriefing of the new translation, usually with patients drawn from the target population

Review of Cognitive Debriefing
8

Review of Cognitive Debriefing

Cognitive debriefing results are reviewed and the translation finalized

Proofreading
9

Proofreading

The finalized translation is proofread

Final Report
10

Final Report

Report is written on the development of the translation

Our Key Projects

Siemens Healthineers

Translations done on client's Medical reports related to peripheral vascular disease and hypertension.

Limbus

Translated client's equipment manual related to contouring in RT-Structure Sets and renaming structures according to TG263 standard.

Path

Translated the production report for Upacicalcet sodium hydrate (AJT240 Na), an active pharmaceutical ingredient.

3H Medi Solution

Translated and Transcribed, a clinical project where the client interviewed a set of patients about a particular health issue.

Sanofi

High-quality translations were completed on Sanofi's adverse event reports, developed by the CIOMS Council.

Alvogen

Translated 121 files of Pharmaceutical and Chemical–Formulation Development and Quality Assurance Reports for Alvogen.

Koru

Translated catalogs for client's various medical solutions that help with treating and maintaining the skin.

Jeisyes

Translated a Clinical Research Paper related to High-Intensity focused Ultrasound that Decreases Subcutaneous Fat Tissue Thickness.

Learn more about our Linguistic Validation services!

Client Testimonials

We've helped many medical clients with the best quality medical translation services. Here's what they have to say about the quality and value we provide.

"I am grateful to the entire team for being so generous and sincere towards our requirements. At this point, we can almost blindly trust you with everything. The team barely needed our supervision and the result delivered was exactly what we were looking for. Honestly, what else could we ask for! Thank you, Ulatus. You're simply the best!"

Alvogen

"I have been using Ulatus services regularly for some time now and their quality of work is really good. The style and accuracy with which they translated my various documents was exactly what I expected it to be. I am really impressed with their team who worked closely with me to translate our vision into reality."

Abbott

"Through their excellent project management system, Ulatus surpassed all my expectations and passed fairly. Given the demands of this project, it was difficult to meet my requirements but Ulatus successfully delivered my work following the timelines and high-quality standards. It is a miracle company."

Sanofi

"I am grateful to the entire team for being so generous and sincere towards our requirements. At this point, we can almost blindly trust you with everything. The team barely needed our supervision and the result delivered was exactly what we were looking for. Honestly, what else could we ask for! Thank you, Ulatus. You're simply the best!"

Alvogen

"I have been using Ulatus services regularly for some time now and their quality of work is really good. The style and accuracy with which they translated my various documents was exactly what I expected it to be. I am really impressed with their team who worked closely with me to translate our vision into reality."

Abbott

Our Memberships

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Ensure best quality translation in any language through linguistic validation done by medical experts.

Our ISO Certifications

As a professional translation service provider, our certifications demonstrate our commitment to clients and business partners worldwide.

Translation Services

ISO 17100:2015

Requirements For Translation Services

Information Security

ISO/IEC 27001:2022

Information Security Management System

Medical Devices

ISO 13485:2016

Medical Devices - Quality Management System

Quality Management

ISO 9001:2015

Quality Management System

Frequently Asked Questions

Ulatus specializes in professional linguistic validation for multilingual clinical trials across various healthcare and therapeutic areas. Our life sciences translation best practices are tailored for simpler, faster linguistic validation of Clinical Outcome Assessments (COAs), resulting in better outcomes than ever before.

At Ulatus, we prioritize the confidentiality and security of our clients' data. Our translators and project managers sign non-disclosure agreements (NDAs), and we employ secure file transfer protocols and data encryption methods to safeguard sensitive information throughout the Linguistic Validation process.

The most accurate way to determine the price for your linguistic validation is by filling out our quotation form. Once submitted, we provide a free consultation with no obligations.

Our Linguistic Validation Service covers a wide range of medical documents, including patient-reported outcome measures (PROMs), clinician-reported outcome measures (ClinROs), observer-reported outcome measures (ObsROs), quality of life measures (QoL), informed consent forms, medical questionnaires, and more.