A comprehensive linguistic validation service helps you to meet the requirements for successfully clearing the Clinical outcome assessment (COA) by strongly following the FDA and ISPOR procedures. This service also helps you to meet the regulatory agency standards by ensuring reliability, patient data accuracy and content validity of translations. At Ulatus, we ensure that the translated terminologies and concepts are culturally equivalent and adapted according to the regulator’s strict guidelines.

Clinical trials are increasingly being internationalized. Also, the development of instruments is being predominantly in English. Ulatus’ incorporated ISPOR compliant Linguistic Validation and Cognitive Debriefing methodology ensures that your translated COA (Clinical Outcome Assessment) instruments are both conceptually equivalent with the original source and relevant to the new target culture.

Ulatus demonstrates in-depth expertise by ensuring that your instrument conceptually, culturally, and constructively coequal all targeted languages.

Helping You Overcome All Challenges

Inadequate attention given to inputs received from patients, clinicians, regulatory agencies, payers or sponsors, creates needless hurdles.

This could lead to the concept(s) of interest being :

  • Inconsistent with the trial objectives
  • Challenging for interpretation of the clinical trial findings

Ulatus’ linguistic validation team helps to interpret all the content rightfully in order to retain its real meaning and assure consistency. The professional clinicians and healthcare professionals coupled with FDA and ISPOR compliant practices allow us to conduct cognitive interviews. Our explicit objective is to minimize error in measurement of the concept of interest (COI) and achieve clarity in the interpretation of study results when evaluating treatment benefits.

Ulatus Advantage

When it comes to localization solutions, Ulatus provides the most efficient structures and equipment to guarantee maximum quality in any project!

Specialized Subject-Area Matching
Quality-Driven Technology
In-House Expertise
24x7 Dedicated Localization Manager
ROI-Driven Localization Solutions
ISO-Certified Processes

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