Clinical Affairs & Medical Writing

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Consulting

Clinical affairs & medical writing

Does the clinical evaluation mean a lot of effort for you that you would like to delegate?

Does your team also get buried under a mountain of reports on safety and performance?

Do you need to set up a clinical study, but are unsure about the planning?

Only with solid clinical evidence can you secure market access for your product.
Benefit from our experience and contact us. We are here to help.
 

Support

Clinical affairs

Our Clinical Affairs department consists of experts who support you in generating, analyzing, and evaluating preclinical and clinical data. The focus is the clinical evaluation and biological evaluation for medical devices, the performance evaluation for IVDs, and the Common Technical Document for pharmaceuticals.

In addition, we conduct specific research for you in relevant literature databases or registers and help you with the planning, implementation, and documentation of your clinical study. This includes, for example, the creation of study plans and reports, investigator brochures, or case report forms.

After market authorization, the team will help you to document the performance and safety data for your medical device, IVD or medicinal product during the clinical follow-up and update of existing reports. This includes, but is not limited to, the Periodic Safety Update Report, the Post-Market Clinical Follow-up Plans and Reports, and the Periodic Benefit Risk Evaluation Report.

Support

Medical writing

Our team also supports you in the content creation of scientific publications and marketing materials to correctly inform professionals about the development progress and effectiveness of your drugs and medical devices. In addition, we help you to create the summary report on safety and clinical performance, the summary of product characteristics and the summary of your study results for laypeople.

Services

Our consulting services for you!

  • Creation of processes and templates for the clinical affairs area
  • Creation and updating of clinical evaluations according to the EU MDR and performance evaluations according to the EU IVDR
  • Creation and updating of plan and report for the biological evaluation
  • Creation of Common Technical Documents for pharmaceuticals
  • Creation of topic-specific summaries after conducting literature searches (Pubmed, Embase, etc.) to obtain preclinical and clinical data
  • Clinical evaluation of marketing claims
  • Creation of benefit-risk assessments
  • Creation of documents and applications for clinical trials:
    • Clinical investigation / study plan and report
    • Case report form
    • Investigator’s brochure
    • Patient information / consent (informed consent form)
       
  • Monitoring and evaluation of clinical studies:
    • Monitoring
    • Data management
    • Statistical analysis of clinical data
  • Creation of plans and reports for post-market clinical follow-up (PMCF, PMPF)
  • Creation and updating of PSUR, PMSR and PBRER
  • Creation and updating of the SSCP for medical devices, the SSP for IVDs and the SPC/SmPC for pharmaceuticals
  • Creation of manuscripts for scientific publications, posters and abstracts (according to CONSORT, STROBE etc.)
  • Summary of study results for laypersons (Lay Summaries)
  • Training at your location or at our academy in Hamburg

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News

Always up to date

The EU Commission has updated the timelines for the EUDAMED modules. A significant milestone is the announcement of the finalization in the EU…

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AI systems in medical devices introduce a new set of risks and  performance parameters. Without a lifecycle for each model, manufacturers cannot…

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Mark your calendars! Next year, we are excited to offer the NSF Summer Camp - Intensive Course for Regulatory Affairs Managers once again. The…

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Contact

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Get in touch with us free of charge to discuss your individual needs and find out more details about our services.

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NSF Prosystem GmbH
Beim Strohhause 17
20097 Hamburg

+49 40-668-788-100

+49 40-668-788-199

info-medicaldevices@nsf.org