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 Language Management and Localization Service

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Quality Management

Medical Translations

Clinical Trials

PRO Linguistic Validation

Medical Reports

MSDS Translations

 

 

Medical and pharmaceutical translations between English and Czech
 

Translations of documents for clinical trials

We translate English and Czech documents used at all stages before, during and after performing clinical trials.

 

Translations and linguistic validations of patient reported outcomes (PRO)

We perform translation, back-translation and linguistic validation of questionnaires for patient reported outcomes between English and Czech used to evaluate results of clinical studies

 

Translation of discharge summaries and medical reports

We translate discharge summaries and medical reports between English and Czech for internationally conducted (multicentric) clinical trials.

 

Summary of product characteristics (SPC)

Our services also include pharmaceutical translations complying with requirements and guidelines of European Medicines Agency (EMA) for product information. EMA website includes the following continuously updated product information templates localized from English into Czech that we use during translation:

Summary of product characteristics

Excipients in the label and package leaflet of medicinal products for human use
Statements for use in Section 4.6 “Pregnancy and lactation” of SPC
MedDRA (version 12.0) terminology to be used in Section 4.8 “Undesirable effects” of SmPC

Special conditons for storage.

 

Patient information leaflet (PIL)

We translate patient information leaflets based on Summary of product characteristics (they also regulated by European Medicines Agency) and providing information to patients.

 

And also:

Instructions for use (IFU)

 

Operation manuals for medical instruments

 

       

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