Portfolio Medical Writing
Medicinal Products and Pharmaceuticals
Clinical Trials:
- Clinical trial reports and trial protocols taking into account international ICH standards and in accordance with the legal requirements of EU CTR 536/2014 and the German Medicinal Product Act.
- Lay summary of the final report.
- Participant Narratives according to ICH-E3 Chapter 14.3.3.
Non-interventional Studies:
- Study reports and observational plans for observational studies (German: "Anwendungsbeobachtungen"), post-authorization safety (PASS) and post-authorization efficacy studies (PAES) according to European requirements and guidelines (GVP).
Medical Writing services regarding other documents (e.g., PSUR, PBRER, RMP, AMNOG, DiGA, DiPA application) as well as documents according to US requirements (FDA) may be available upon request.
Medical Devices
Clinical Investigations and Performance Studies:
- Clinical investigation plans and reports in compliance with international standards (ISO 14155:2020 or ISO 20916:2019) and in accordance with the legal requirements of the EU MDR 2017/745 or EU IVDR 2017/746 as well as German legislation (MPDG, MPAMIV) for both clinical investigation within the framework of CE certification (conformity assessment) and for clinical investigations after the device has been placed on the market (post-market clinical follow-up).
Additional services, such as literature research or medical writing services as part of a clinical evaluation, are available upon request.
Services on regulatory documents according to US requirements (FDA) also upon request.
Scientific Writing
Abstracts.
Congress posters.
Manuscripts for publication.
Slide kits for oral presentations.
Proofreading, Editing, Publishing
Quality-Check of documents.
Translation (German and English).
Publishing (indexing and hyperlinking) of documents.