Medical Writing

Our team of medical writers works to integrate the medical and statistical results of your trials into an electronic or paper document that meets the needs of clients’ and regulatory requirements.
All our medical writers are qualified to the PhD level, undergo regular training and have a wealth of experience in writing a comprehensive range of documents. They have access to cross-functional professionals internally with whom they collaborate on statistical consultancy and data management areas, so that the end result is a holistic, customised document.

Documents produced are comprehensive and aimed at many different audiences, ranging from corporate boards of directors, to consultants and medical representatives, regulatory authorities, and the general public. We appreciate the importance of targeting to specific audiences.

We can prepare a wide range of documents involved in the drug regulatory process including:
•    clinical study reports
•    protocols, clinical investigational plans (CIPs)
•    investigator’s brochures
•    clinical overviews
•    clinical summaries
All our regulatory writing is done in accordance with our SOPs (or, if you prefer, your SOPs) to GCP-compliant standards.
We take the content of our medical writing seriously, and always make sure that the documents we produce are scientifically rigorous.

Clinical study reports (CSR)
Our team of medical writers has considerable experience writing clinical study reports. We ensure that the report:
• Is fully compliant with International Conference on Harmonisation (ICH) guidelines
• Is prepared to either a client specific format or to the GCP-Service style
• Is clearly written throughout to ensure there are no ambiguities
• Presents the findings of the study in a clear and concise manner
• Succinctly discusses the clinical relevance of the results and highlights any unexpected findings or potential problems
• Undergoes thorough QC to ensure accuracy and consistency
• Is based on sound data, and we will flag any problems in the data we identify as we write the report

Protocols
GCP-Service can help you with the writing of study protocols, ensuring that:
• The methodology and planned statistical analyses are optimised for the specified study objectives
• The protocol is free of all possible ambiguities that might affect the conduct of the study
• The study will adhere to guidelines for Good Clinical Practice (GCP) and other ethical considerations
• Your clinical trial has the best chance of being approved by the appropriate International Ethics Committee (IEC), International Review Board (IRB) and Competent Authority (CA)