My approach to medical writing is guided by internationally recognised regulatory requirements, clinical research guidelines and principles of scientific integrity.
I focus on producing accurate, clear, consistent and well-structured documentation, with careful attention to the intended purpose of each document, its target audience and applicable requirements.
Regulatory Framework & Good Clinical Practice
I work with reference to relevant international and European regulatory frameworks and guidance, including:
- ICH E3 – Structure and Content of Clinical Study Reports
- ICH E6(R3) – Good Clinical Practice (GCP)
- ICH E8(R1) – General Considerations for Clinical Studies
- ICH M11 – Clinical Electronic Structured Harmonised Protocol (CeSHarP)
- EU Clinical Trials Regulation (EU) No 536/2014
- EU Medical Device Regulation (MDR) 2017/745
- ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects
Clinical Research Design & Reporting
I take into account recognised guidelines supporting the design, transparency and reporting of clinical research, including:
- CONSORT – Consolidated Standards of Reporting Trials
- SPIRIT – Standard Protocol Items: Recommendations for Interventional Trials
Data Integrity & Documentation
I recognise the importance of maintaining reliable, traceable and consistent clinical research documentation, in line with:
- ALCOA++ principles of data integrity
Publication Ethics & Authorship
Scientific integrity and transparent publication practices are important considerations in the preparation of scientific and medical content. Relevant guidance includes:
- ICMJE Recommendations
- COPE – Committee on Publication Ethics
- CRediT – Contributor Roles Taxonomy
Quality by Design
My approach to quality also reflects the principles of:
- Quality by Design (QbD)
- Critical-to-Quality (CtQ) factors
These principles support a proactive approach to quality, with attention to critical aspects of clinical research and documentation from the planning stage onwards.
GCP Training
I have completed training in ICH E6(R3) – Good Clinical Practice (GCP), reflecting my commitment to maintaining up-to-date knowledge of international standards for clinical trial conduct and documentation.
Looking for medical writing support?
Get in touch to discuss your project and documentation needs.