Medical Writing is an integral part of clinical research and our team of specialist medical writers deliver accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards.
Our medical writers become an extension of your team by being responsive and flexible to your needs, using our expertise to transform your complex and diverse data into an accurate and evidence-based account of the clinical profile of your drug in relation to treatment and patient safety.
We have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. All documents produced by Quanticate undergo thorough scientific, statistical, editorial and quality control review.
Quanticate’s medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy.
This paper on 'Semi-Automated Patient Safety Narratives' explains what to do when a large volume of narratives is required within a restrictive time frame and details how a semi-automated approach to narrative writing can be used to address this challenge.
This paper describes current regulatory requirements with regards to patient safety narratives. It details a proposed process for their development and review and examines ways to lessen the burden of time and cost.
This article outlines the support needed from medical writers during the design, conduct and reporting of Phase I studies, but also their obligations when it comes to publishing results.
This paper looks at how a Medical Writer should contribute to the production of a quality ISS/ISE. It follows a previous white paper on the role of Statisticians and Programmers in the production of integrated summaries.