Regulatory & Medical Writing Services

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.

Regulatory and Clinical Writing

ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
Study Protocols
Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
Investigator Brochures
Patient Safety Narratives
Patient information including Informed Consent, Lay Person Summaries and Patient Brochures
Pharmacovigilance documents such as Periodic Safety Update Reports
Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Clinical Research Organization (CRO)
Standalone Quality Checks

Semi-Automated Patient Safety Narratives

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.