Cromos Pharma has built a very strong team of medical writers with considerable experience in medical and regulatory writing services. Our aim is to create concise, well-structured documents that will satisfy the requirements of multiple regulatory authorities in various countries. Adhering to appropriate regulatory guidelines, international standards and scientific integrity are critical components in the development and delivery of all Cromos Pharma's study documents.

Cromos Pharma’s medical writing team comprises qualified MDs many of which also hold a PhD degree. Within the last five (5) years our team has developed comprehensive documents for Phase I-IV studies within multiple therapeutic areas, including oncology, cardiovascular diseases, respiratory diseases, urology, ophthalmology, dermatology, infectious diseases and many more. Additional details on our expertise in medical writing are provided in "Our experience" section.

We offer the following medical writing services:

  • Study concepts and outlines
  • Clinical study protocols and amendments
  • SAP for inclusion into protocol
  • Investigator brochures (IB)
  • Investigational Medicinal Product Dossiers (IMPD)
  • Patient informed consent forms (ICF)
  • Clinical study reports (CSR)
  • Executive summaries for efficacy or safety, ISS, ISE
  • Reviews of clinical and nonclinical data
  • Patient narratives, SAE narratives
  • Abstracts, posters and journal articles

If you would like additional information on the preparation of any of the above sample documents for your study, please contact our Business Development team.