Medical writing Services in clinical studies includes the precise and regulatorily compliant creation of central study documents. Without a concise and clear clinical study (trial) protocol (CSP or CTP for medicinal product studies) or clinical investigation plan (CIP, for medical device studies), no study authorization may be applied for. This plan will serve investigators as clear instructions on study conduct and is central to the planning, conduct and analysis of a clinical study by CRO and sponsor.

Further documentation through the study’s life cycle is needed so that a CRO should offer Medical Writing Services including the following:

• The creation of study plans (CSP/CTP or CIP) that result from an interdisciplinary discussion of sponsor, CRO and further stakeholders and are scientifically sound and regulatorily compliant.
• The development of patient information and Informed Consent Forms (ICFs) that are easy to comprehend by the patient, promoting engagement and compliance and being in line with GCP stipulations and the Declaration of Helsinki.
• After data analysis and upon study closure, the preparation of Clinical Study Reports (CSRs) that adhere to regulatory guidelines (e.g., ICH E3) and that present data, analysis results, and conclusions.
• Expertise in authoring manuscripts for peer-reviewed journals and conference presentations is a welcome extra for the efficient dissemination of study findings within the scientific community.

As Sponsor, when selecting a CRO for (or including) services related to medical or scientific writing, it is advisable to consider the following key aspects:

1- Scientific knowledge with regards to study design, the product (drug/medical device) and indication under investigation, and the medical context.

2- The Standard Operating Procedures (SOPs) for medical writing processes and the templates to be used should be current and regulatorily compliant.

3- Local and national requirements will need to be respected.

4- Information technology (IT-) related aspects need early addressing.

Need help with this? Reach out today to receive a thorough assessment of your medical writing needs!

Autor: Dr. Christoph Ortland, November 2023