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Medical Writing & Reporting

Clinical Trials Phase I - IVNon-interventional StudiesMedical Devices

Medical Writing – Clinical Trials Phase I – IV

 

Our team of experienced medical writers has profound experience in the preparation of clinical study protocols, clinical study reports, submission documents, abstracts, posters, publications and further scientific information materials. Moreover, we generate risk management plans, periodic safety update reports etc. (safety writing). In close cooperation with our specialized departments, we achieve the highest quality of services.

 

Do not hesitate to contact us, if you have further requests in medical writing.

 

Our range of medical writing services:

 

  • Clinical study protocols, reports and other regulatory documents
    • Clinical Study Protocols (CSPs) according to ICH-E6
    • Clinical Study Reports (CSRs) according to ICH-E3
    • Clinical Overview (Module 2.5), Summary of Clinical Efficacy (Module 2.7.3), Summary of Clinical Safety (Module 2.7.4) in CTD format according to ICH-M4
    • Investigator’s Brochure (IB)
    • Clinical parts of the Investigational Medicinal Product Dossiers (IMPD) according to EC Directive 2001/20/EC
  • Safety writing
    • Risk Management Plans (RMPs)
    • Development Safety Update Reports (DSURs)
    • Periodic Safety Update Reports (PSURs)
  • Publication manuscripts, abstracts & posters
    • Publication manuscripts in German or English language in accordance with international guidelines as well as specific author’s guidelines
    • Organization of the peer review process
    • Abstracts and posters (in hard copy or electronically) according to the congress specifications
    • On-line submission

Your contact for Medical Writing – Clinical Trials Phase I – IV

Dr. Christina Windisch

Dr. Christina Windisch

Christina.Windisch@winicker-norimed.com
+49 (0) 911 / 9 26 80 8736

Medical Writing – Non-interventional Studies

 

As a result of the increased requirements for non-interventional studies, the quality of study documents, such as observational plan and study report, is of utmost importance.

 

Our experienced medical writing team will take ownership of your needs!

 

Our range of medical writing services:

 

      • Observational plans
        • Non-interventional studies including post-authorization efficacy studies (PAES)
        • Post-authorization safety studies (PASS) according to EMA/623947/2012
      • Study reports
        • Study reports based on clinical study reports (CSRs) according to ICH-E3
        • PASS reports according to EMA/48663/2013
      • Publication manuscripts, abstracts & posters
        • Publication manuscripts in German or English in accordance with international guidelines as well as the specific author‘s guidelines
        • Organization of the peer review process
        • Abstracts and posters (in hard copy or electronically) according to the congress specifications
        • On-line submission

 

Your contact for Medical Writing – Non-interventional Studies

Dr. Christina Windisch

Dr. Christina Windisch

Christina.Windisch@winicker-norimed.com
+49 (0) 911 / 9 26 80 8736

Medical Wirting – Medical Devices

 

Besides thorough planning, a clearly written clinical investigation plan (CIP) is the premise for a successful conduct of your medical device project. One of the last steps to ensure an equally successful completion of your project is the preparation of a comprehensive clinical investigation report (CIR). Apart from being mandatory for CA/EC submission , the CIR is also essential for the presentation of your data in the context of the CE-conformity assessment or the recertification procedure.

 

Our range of medical writing services:

 

        • Clinical investigations plans according to ISO14155 and MEDDEV
        • Interim reports for submission to ethical committees and competent authorities
        • Clinical investigation reports in accordance with ISO14155 and all its relevant attachments
        • Safety reports (both final reports and regular reports as required)
        • Posters, abstracts
        • Publication manuscripts

Your contact for Medical Writing – Medical Devices

Dr. Christina Windisch

Dr. Christina Windisch

Christina.Windisch@winicker-norimed.com
+49 (0) 911 / 9 26 80 8736

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