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Clinical Study Report Translation
Clinical Study Reports (CSRs) are critical means by which regulators can assess the
outcome of clinical studies. Their format and content are defined in Guideline for Industry
Structure and Content of Clinical Study Reports (ICH E3). A clinical study report must
reflect the detail and scientific rigor accurately. CSRs also include Clinical Trial Reports –
the new EU terminology for CSRs when the study report pertains to an interventional
(rather than non-interventional) clinical trial. The trial subject documentation has unique
translation requirements. MedTrans has experience translating content for clinical study
reports destined for a variety of regulatory markets. From recruiting documents to
surveys and evaluations, documents that address patients and subjects directly must and
will be translated professionally by our certificated translators.
Contents Included in CSRs:
Clinical trial's methods, design and results.
Gathered data and treatment details, in the interests of safety and efficacy.
Features of Our Translation Service
Clinical subject matter expertise.
Custom workflow design.
Best quality assurance processes.
Leading Pharmaceutical Companies
Medical Device Companies
Contract Research Organizations (CRO)
Why Choose Us?
Rapid, accurate and cost-effective translation for clinical trial communication with strict
compliance and quality assurance.
Our expert team has been providing high-quality, high-stakes translation to clients in
the US and around the world.
MedTrans has long experience in translating hundreds of CSRs for all phases of clinical
development and across most indications. We can help our clients to crystallize the
essential results that regulators need to know. Moreover, we work closely with clients to
meet the challenge of the large numbers of complex subject narratives often r