What is medical writing in clinical trials?
Medical writing is the process of creating, editing, and structuring the technical and scientific documents required for medical-device clinical trials. It covers materials such as the clinical-trial plan, investigator brochure, CRF forms, final reports, and lay summaries. The goal is to ensure that all documents comply with MDR, GCP, and ISO 14155 and are understandable to ethics committees, notified bodies, and end users.
The scope of medical writing across the clinical-trial life cycle
Medical writing spans every trial phase—from planning to reporting. Documents fall into three groups:
- Start-up documents: clinical-trial plan, investigator brochure, informed-consent forms, SOPs,
- Operational documents: CRFs, visit records, adverse-event logs, monitoring notes,
- Final documents: final report, lay summary, clinical evaluation.
Each document is prepared in line with GCP principles and MDR requirements.
The role of medical writing in effective regulatory communication
Medical writing ensures that submissions to ethics committees and notified bodies are consistent, transparent, and logically structured. This demands fluency in clinical and technical language, skill in data handling, and strict adherence to regulator formats.
The role and competencies of a medical writer
A medical writer prepares medical, technical, and regulatory documents that must meet MDR, GCP, and ISO standards (especially ISO 14155). The role blends clinical knowledge, data-analysis skills, and scientific-editing expertise.
Key competencies include:
- knowledge of MDR, GCP, ISO 14155, and the clinical-trial document structure,
- ability to write precisely and clearly in English (and local languages),
- understanding of trial design, conduct, and data analysis,
- experience drafting study plans, clinical reports, and lay summaries,
- capacity to collaborate with study teams, statisticians, and regulators.
Medical writing is a specialised communication function in a complex regulatory environment and has a critical impact on successful device certification.
Creating start-up documents within medical writing
Even during trial design it is essential to prepare the clinical-trial plan, investigator brochure, and consent forms. Their quality directly influences the efficiency of ethics approvals and trial start-up.
Medical writing during the trial
Throughout the study the medical writer updates documents, edits CRFs, records adverse events, and works with the monitoring team. Operational documents must align with the clinical-trial monitoring process and withstand audit scrutiny.
Medical writing after trial completion
After study completion the final report and a lay-reader summary are prepared—both required for post-market surveillance. Accurate report drafting is crucial for clinical evaluation and device registration.
Standards and guidelines applied in medical writing
Medical writing must comply with:
- MDR – clinical-documentation requirements,
- ISO 14155 – documentation rules for medical-device studies,
- ICH-GCP – quality standards for study conduct and reporting,
- ISO 20916 – for IVD performance studies.
How Pure Clinical supports medical writing in clinical trials
Pure Clinical offers end-to-end medical-writing support:
- drafting clinical-trial plans and investigator brochures,
- creating and editing CRFs and ethics documents,
- preparing final reports and lay summaries,
- reviewing documents for MDR and ISO compliance,
- facilitating communication with notified bodies and ethics committees.
Our expertise enables rapid development of high-quality materials that meet regulatory expectations and accelerate market approval.
FAQ
Can a medical writer be responsible for documentation in multiple languages within a single trial?
Yes – but it requires close collaboration with professional translators and validation of each version for both content accuracy and regulatory alignment. Documents like informed consent forms must meet local ethical standards, and each version should undergo independent quality control before ethics committee submission.
How does medical writing impact compliance during a notified body audit?
Does using templates in medical writing accelerate document approval?
Using templates aligned with ISO and GCP standards can significantly streamline document drafting and review, especially in multicenter trials. Format standardization shortens approval timelines by quality teams and regulators, reduces revision cycles, and expedites trial initiation.