Medical Writing

Inference’s medical writers have years of experience in preparing ICH-compliant study documents from protocols to study reports to integrated documents for regulatory submission. They have broad experience in using sponsor’s templates and style guides. And if no sponsor template is available Inference will use its own templates. Our writers work closely with our biostatistics, programming, PK/PD and project management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards. 

• Protocol – Our writers can prepare a detailed protocol by aligning the objectives, study design and methods by using their extensive understanding of the regulatory framework for presenting such information as well the need for scientific clarity in executing the corresponding clinical trial.
• Clinical Study Reports – We have resources with deep experience in the preparation of CSRs, based on the ICH E3 guideline. Our writers work closely with the biostatisticians to make sure the results are presented and interpreted accurately.
• Integrated Summary of Safety/Efficacy – We prepare integrated reports such as efficacy, PK and safety summaries as well as overviews and briefing books for submission to regulators.
• Other Reports – We also write other reports such as Development Plans, Investigative Brochures, Annual Safety Reports etc.