Scientific & Medical Writing

Pharma IT provides expert medical writing services in all key therapeutic areas. Our highly qualified professionals possess consummate medical writing expertise backed by years of experience in preparing clinical, regulatory, pharmacovigilance, and medical marketing documents for the world’s top pharmaceutical companies.

 

Our suite of medical writing services include

Regulatory and research documents

  • Study protocols
  • Informed Consent Documents
  • Case Report Forms
  • Statistical Analysis Plans
  • Study reports
  • Investigator’s Brochures
  • Summary of Product Characteristics/Prescribing Information
  • Clinical Summaries and Overviews (Common Technical Document Modules 2.5 and 2.7)
  • Subject Narratives
  • Developmental and Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports
  • Risk Management Plans

 Scientific publications and presentations

  • Journal articles (original research articles, narrative reviews, systematic reviews/meta‐analyses)
  • Congress presentations (abstracts, slide kits, posters, e-communications)
  • Publication planning support

Disease and drug-related educational and promotional literature

 

We possess expertise in reporting various types of research, including interventional studies, observational designs, pharmacokinetic/pharmacodynamic modeling and simulations, health economic assessments, and real-world evidence studies.

At Pharma IT, you can expect a high level of scientific rigor and consistent delivery of high-quality guideline-compliant documents to support your clinical development and lifecycle management programs.

 

If you need support don’t hesitate to contact us.

Meet the Scientific & Medical Writing team:

Medical Writer Consultant
Kaushik Sengupta

Senior Medical Writing Consultant with over 8 years of experience from the pharmaceutical industry as a Senior/Expert Medical Writer. Has prepared numerous high-quality regulatory and research documents for leading global pharmaceutical companies. Typically, these documents have been based on Phase I–IV studies from most major therapeutic areas. Holds a Master in Dentistry from Canada and has pursued a PhD in epidemiology from Copenhagen University.