We provide professional translation services
into more then 12 languages for all type of clinical trial ndocumentation that meets the requirements
of the various regulations issued by
the U.S. Food and Drug Administration
(FDA),
the Health Canada Therapeutic Products Directorate (TCP),
the Quebec Funds for Clinical Research (FRCQ) and
the European Medicines Agency (EMEA),
the Ministry of Health of the Russian Federation
the Ministry of Health of Ukraine
the Ministry of Health of Kazahstan
the Ministry of Health of Armenia
the Ministry of Health of Bulgaria
the Ministry of Health of Rumania, etc.
Our consultants, ICH GCP trained professionals who
know in details the FDA, TCP, FRCQ & EMEA regulations and
terminology provide the following:
Translation
of Clinical Trial Documentation
-
Clinical Trial Protocols
-
Case Report Forms (CRF)
incl. eCRF
-
Informed Consent Forms (ICF)
-
Investigators' Brochures
(IB)
-
Patient Information Leaflets (PIL)
-
Patient Questionnaires & Diaries, incl.
eDiaries
-
Patient-Reported Outcomes
(PRO), including ePRO
-
Scales and QoL Instruments
-
Adverse Events Reports
Translation
of Drug Registration Documentation
-
Drug Information (labels,
inserts, packaging etc.)
-
Standard Operating
Procedures (SOP)
-
Drug Registration Dossiers
-
Regulatory Applications
-
Medical Publications
Translations
for medical device manufacturers
-
Operating and Installation
Manuals
-
Packaging Inserts and Labels
-
Patents for Medical and
Surgical Devices
-
Manufacturing Process
Descriptions etc.
-
GLP, GCP and GMP
documentation
All our interpreters are medical
or biomedical professionals, native speakers of the corresponding
languages. They are all trained as CRP (CRA/CRC) so they have full professional understanding of what they
translate, which removes or reduces substantially the need of back translation and accelerates the process.
