Numerous effective supported clinical studies

ClinStat realized considerable number of successful studies

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ClinStat - Data Management

Data Management

Superb data management is an important factor in clinical research

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ClinStat - Statistical Programming

Stat. Programming

Comprehensive

Services for any phase of drug development

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ClinStat - Medical Writing

Medical Writing

Planning of studies, accurate reporting and approval process

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Clinstat - HEOR/Market Access

HEOR/Market Access

compiling data in the right way, at the right time

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Biostatistics

ClinStat offers the complete range of statistical services

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ClinStat - Statistical Programming

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ClinStat GmbH

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+49 2234 9919911

Email:           info@clinstat.eu  
Homepage:  www.clinstat.eu

Max-Planck-Str. 22a
50858 Cologne/Germany


Institute for clinical
research and statistics



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ClinStat

Medical writing and the preparation of research-relevant documents must meet regulatory and clinical requirements. We ensure this through diligent planning of studies, accurate reporting, a well-documented approval process as well as constant monitoring and review.
All facts must be depicted and presented in a precise, clear and comprehensive manner.  With our know-how and comprehensive resources, our team will prepare all study-specific documents and presentations for you. You can either take advantage of individual services included in our range of services or our complete medical writing service. We will work closely with you, taking company and study-specific needs into account, and we will always keep you up-to-date.  


We support you with the preparation of:
       All medical/scientific information from literature
       Test plans
       Documentation sheets (CRFs)
       Standard operating procedures (SOPs)
       Clinical study reports and amendments
       Expert reports
       Meta-analyses
       Safety reports
       Interim reports, final report writing
       Documents to be submitted to government agencies and ethics committees
       Clinical summaries and overviews for worldwide regulatory submissions (MAA, NDA, BLA in CTD           and eCTD format)
       Briefing documents for regulatory agencies
       Responses to questions from regulatory authorities


Medical Writing


Medical Writing

we are regularly seeking data managers, statistical programmers, biometricians/statisticians and medical writers

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Careers
at ClinStat

TLF programming accurate, clear and corresponding to

ICH E3 guidelines

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Statistical
Programming

Data Management
Biostatistics
Statistical Programming
HEOR/Market Access
Medical Writing