Medical Writing Services

Specialist services and expertise in Medical Writing to support your
regulatory submission

Providing accurate, high-quality clinical and regulatory documentation

The development of accurate, high-quality clinical and regulatory documentation by expert Medical Writers is key to the success of a drug, biologic, device or diagnostic clinical research project. Medical Writers are a critical part of the communication process within a clinical trial or clinical programme in terms of ensuring medical understanding for a range of audiences, including patients, investigators, trial sites, sponsors and regulatory agencies. They also have a vital role in the accurate reporting of clinical trial data. StatisticaMedica’s Medical Writing Services ensure all clinical and regulatory documentation is accurate, comprehensive and high quality.

Understanding the mindset of the regulatory reviewer

StatisticaMedica interacts directly with the FDA for regulatory submissions on our client’s behalf. Our insight into the regulatory reviewers’ requirements results in significantly reduced review times and minimises any FDA questions on the reporting of the data.

StatisticaMedica understands the complexities of writing in a highly regulated environment and offers first-class Medical Writing Services to complement the core Biostatistical Services to support clients towards a successful regulatory submission.

Medical Writing support throughout the full product development life cycle

The Medical Writing support provided by StatisticaMedica covers the full product development life cycle, from research/preclinical studies, through clinical development, and post-approval. Documents are developed in accordance with regulatory guidelines (e.g., ICH GCP) and client practices and requirements. Our Medical Writing Consultant has extensive experience preparing clinical, regulatory and post-marketing documents in a wide range of therapeutic areas. Our flexible, efficient and collaborative approach ensures high-quality deliverables are on target and on time.

Proven Experience

  • Over 50 peer-reviewed publications (first author, co-author or medical writing assistance provided), podcasts and webinars in a range of therapeutic areas, including cardiovascular, oncology and dermatology.
  • Over 130 clinical study protocols (100 of which are in oncology)
  • Over 50 clinical study reports
  • Reviewed and edited over 300 manuscripts for peer-reviewed journals

Our Medical Writing Services include:

Supporting the core Biostatistical Services

Medical Writing Services at StatisticaMedica include developing, writing, reviewing and editing the following core clinical trial-related documents:
 
  • Protocols 
  • Protocol Synopses 
  • Protocol Amendments 
  • Clinical Study Reports
  • Integrated Summary of Safety and 
    Efficacy (ISS-ISE)     
  • Manuscripts 
  • Abstracts 

Additional Medical Writing Services

StatisticaMedica also provides expert Medical Writing support for the following documents and resources:

  • Investigator Brochures
  • Articles 
  • Posters 
  • Presentations 
  • Training materials 
  • SOPs, WPs, WIs, Job Aids
  • Books, blogs, podcasts, webinars