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.
Clinical subject matter expertise.
Custom workflow design.
Best quality assurance processes.
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Contract Research Organizations (CRO)
- 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 required for CSRs. The CSRs which we prepare optimize and streamline the preparation of ensuing CTDs.
MedTrans provides full clinical trial support, including processing trial sample documents, report evaluations, data management, and preparation for approval. Please contact us to discuss your specific translation requirements or receive more information about our suite of clinical trial translation services.
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