Medical Writing

Scientific texts  such as clinical investigation protocol (CIP) and publications in professional medical journals  follow different rules than texts for laypeople e.g. patient information, etc.

In medical writing, the focus is on conveying a clear message, regardless of whether it is a study document, patient information or scientific report.  We can support you with an experienced medical writers and our deep knowledge of guidelines and regulations.

Profit from our expertise. We will ensure that your documents meet and exceed the requirements, and that your Clinical Investigation Trial remains on track.

Clinical Trial Documents

For Clinical Investgation Trials  the target audience is composed of regulators and ethic committee members of varying background that want and need to assess if the documents contain all relevant information and are written in a clear and concise manner that avoids ambiguity. These requirements can at times be difficult to achieve.

Study documents in Clinical Investgation Trials are reviewed and assessed by various persons and institutions such Ethic Committees and Authorities, for comprehensibility, scientific accuracy, safety etc. This makes it all the more important to highlight relevant information clearly and concisely in the study documents. Publication guidelines and layouts must be observed. Legal requirements from clinical research, e.g. EN ISO 14155, MDCG etc. place further challenges on medial writing.

TRIQ work closely with our Clinical Operations and Regulatory Experts so that their knowledge and experience become an integral part of all study documents while maintaining the readability and comprehension required for the targeted audience.

Scientific Publications

The publication of study results in scientific journals requires careful research and cooperation with the various co-authors the main thing is to put the results into a scientific context. The results must be summarized clearly, concisely and in a structured way.

Our scientific / medical writers can support you.

Medical Writing Services

We can assist you with any of the documents needed for medical device development:

• Clinical Investigation Plan (CIP)
• Investigator’s Brochure (IB)
• Patient Information and Informed Consent Form (ICF)
• Instructions for use (IFU)
• Questionnaires
• Patient Facing Materials
• Recruitment Materials
• Clinical Study Report (CSR)
• Clinical Overview and Summary
• Clinical Evaluation Plan / Reports
• Scientific Articles