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Medical Writing Services

Medical Writing is an integral part of clinical research. Our Medical Writers work closely with our colleagues in the biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards.

Our Medical Writers become an extension of your team by being flexible to your scope, using our expertise to guide you through your clinical data and demonstrate the efficacy of your drug and improve 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. Examples include:

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 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)

 

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

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Phase I Studies Medical Writing

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ISS ISE Role of the Medical Writer

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"Thanks so much for your constant diligence and persistence on a high priority project to support an advisory committee meeting!"
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