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Medical Writing Services

Regulatory and Clinical Writing plus Scientific Communications

 

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

Scientific Communications

  • Conference materials (abstracts, poster presentations and slide sets)
  • Manuscripts
  • Editorial support
  • Journal/conference submission
  • Product website content (for both scientific and patient audiences)
  • Educational material for patients, healthcare professionals and pharmaceutical industry personnel
  • Medical marketing reviews and reports
  • Literature reviews
  • Publication planning

 

Submit a Request for Information

 

Semi Automated Patient Safety Narratives

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.

Semi Automated Patient Safety Narratives

Patient Safety Narratives in Clinical Studies

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.

Phase_I_Studies_Medical_Writing_-_Website

Phase 1 Studies: Roles and Obligations of the Medical Writer

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.

Integrated_Summaries_-_Role_of_Medical_Writer_-_Website

Integrated Summaries of Safety and Efficacy: The Role of the Medical Writer

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.

Latest Blogs on Medical Writing

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