Linguistic Validation




Expanding research to worldwide patient populations has significant health outcomes benefits; yet, it presents a novel set of complexities. At AMPLEXOR, we are ideally positioned to help you navigate the linguistic, cultural and operational challenges of conducting multilingual, multinational clinical outcomes research.
Your success is our goal, no matter how complex or large the study.

BENEFITS

CLINICAL OUTCOMES RESEARCH EXPERTISE
CLINICAL OUTCOMES RESEARCH EXPERTISE

Preserve COAs accuracy and intended meanings across cultures and languages.

ON TIME, EVERY TIME
ON TIME, EVERY TIME

Meeting aggressive regulatory submission deadlines in global target markets.

PROTECT YOUR RESEARCH INVESTMENT
PROTECT YOUR RESEARCH INVESTMENT

Eliminate mistranslations that could put your clinical trial at risk.

Are you planning a study that needs local knowledge with global reach?

Contact our Linguistic Validation team and find out how AMPLEXOR can help.

FEATURES

6000+ CLINICIAN NETWORK
AMPLEXOR actively maintains an extensive network of in-country, native speaking clinicians and medically trained translators. This allows us to quickly assemble translation and review teams to support you with instrument development, planning, and the translation needs of your study.

INDUSTRY THOUGHT LEADERSHIP
As a member of ISPOR and ISOQOL and an active participant in industry special interest groups, we are well versed in the latest translation best practices and the challenges and opportunities international research groups face.

ALL TYPES OF COA INSTRUMENTS
AMPLEXOR can provide Linguistic Validation of all types of COA Instruments:
· Patient Reported Outcomes (PRO)
· Clinician Reported Outcomes (ClinRO)
· Observer Reported Outcomes (ObsRO)
· Performance Outcomes (PerfO)
· eCOAs

50+ THERAPEUTIC AREAS
We cover all therapeutic areas including:

Oncology  |  Dermatology   | Respiratory
Cardiology | Genetic Disease | Urology
CNS/Neurology/Psychiatry | Orthopedics | Pediatrics

 

COMPLIANT PROCESSES
AMPLEXOR understands the need to stay current on the complex and increasingly regulated process of adapting COA instruments for use in global research studies. We follow the evolving guidance on linguistic validation methodology (FDA PRO Guidance, EMA guidelines, and ISPOR Good Practice recommendations) with a strong commitment to global patient focus.

Customized Translation and Linguistic Validation workflows can be tailored according to your study-specific requirements and instruments types.

AN ONGOING PARTNERSHIP 
Linguistic Validation can be carried out either during development or after selection depending on the nature of your study.  By engaging early in the instrument development process, we can help you plan for, and reduce the cost of, future translation.

"Working together with COA developers we can help them design translatability into measures from the start. Suggesting linguistic design choices that increase clarity and simplicity for both the end user and future translation and review teams".      
    Dana Weiss, Director of Linguistic Validation, AMPLEXOR

"Our in-country clinicians and language teams provide more than just translation support. Their local knowledge, operational expertise and clinical training combine to help our clients plan, prepare, and conduct research that's perfectly tailored to local patient groups".        
    Jackie Janeri, Lead Project Manager, AMPLEXOR

Linguistic Validation process adheres strictly to ISPOR guidelines which are recognized by the FDA and EMA.