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Your professional solutions: Precise medical writing for your clinical studies

As an experienced medical writer, I provide you with customised solutions. Discover my manifold services and benefit from high-quality, precise medical writing specifically addressed to your needs. Whether study protocols, clinical study reports, patient information or scientific publications - together we create outstanding quality content that meets the highest standards. Why not let us convey your message in a clear and convincing way?

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Individual + high-quality solutions for your medical texts

All services related to medical + scientific writing from a single service provider

Highest standards through years of professional experience

Preparation of clinical study documents

I offer professional support in the preparation of clinical study documents. This includes, in particular:


  • Creation of study protocols compliant with current regulations, such as Clinical Trial Protocols (CTR) compliant with EU Regulation 536/2014 for drug studies, Clinical Investigation Plans compliant with Medical Device Regulation (EU) 2017/745 for medical device studies and Observation Plans compliant with ICH/GCP for non-interventional and observational studies.


  • Creation of Patient Information and Consent Forms (Informed Consent).


  • Competent preparation of final study reports, such as Clinical Trial Reports according to ICH E3, Clinical Investigation Reports compliant with Medical Device Regulation (EU) 2017/745 and observational study reports compliant with ICH/GCP.



  • Support in the publication of research results and writing of methods/design papers for planned clinical trials
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Comprehensive consulting

Along with the preparation of high-quality study documents, I offer comprehensive consultancy services for your clinical studies, including:


  • Concept development and study design to support you in planning your clinical projects


  • Consulting on the required submission documents for ethics committees and regulatory authorities in Germany such as the Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (PEI) and the Federal Office for Radiation Protection (BfS).
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Translations: German + English

To ensure that your study documents are internationally accessible, I also prepare their translation from German into English and vice versa.

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Who is writing here?

Alexandra Bernhardt, PhD – an experienced medical writer with a passion for science and writing

As a graduate translator and doctorate in clinical psychology, I combine precise writing with scientific expertise. With in-depth experience in stress research and cardiovascular studies, I provide high quality documents according to current standards and regulations. My goal: approval-ready clinical studies with a strong focus on patient safety. I believe sincerity and commitment are an essential part of a strong and sustainable business partnership.

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Blog

In this blog you will find some interesting insights and useful information about medical writing and compliance with standards. Immerse yourself in the world of medical writing!

What is a methods paper?

by Dr. Alexandra Bernhardt • 14 Jul, 2023
A Methods or Design Paper describes in detail the study design, i.e., the research methods and data sources, of a proposed study.

And what is study design?

by Dr. Alexandra Bernhardt • 14 Jul, 2023
The study design is the basis of the research project, i.e. the detailed plan of a particular study. After the research topic has been defined, the specific research question is formulated. The methods of the planned study are usually derived from this, such as the type of study, the design of the data collection, the determination of the evaluation and the presentation of the results.

What is the difference between medical and scientific writing?

by Dr. Alexandra Bernhardt • 14 Jul, 2023
Medical writing refers to the writing of medical texts, while scientific writing describes much more generally the writing of scientific texts from a wide variety of research areas. Medical writing can therefore be understood as a special thematically limited area of scientific writing.

Mein Blog

In meinem Blog finden Sie spannende Einblicke und nützliche Informationen rund um das Verfassen von medizinischen Texten sowie die Einhaltung von Standards. Tauchen Sie ein in die Welt des medizinischen Schreibens!

What is a methods paper?

by Dr. Alexandra Bernhardt • 14 Jul, 2023
A Methods or Design Paper describes in detail the study design, i.e., the research methods and data sources, of a proposed study.

And what is study design?

by Dr. Alexandra Bernhardt • 14 Jul, 2023
The study design is the basis of the research project, i.e. the detailed plan of a particular study. After the research topic has been defined, the specific research question is formulated. The methods of the planned study are usually derived from this, such as the type of study, the design of the data collection, the determination of the evaluation and the presentation of the results.
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