Medical writing

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
Cromos Pharma has amassed an exceptional 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 of qualified MDs, many of whom also hold PhD degrees. Within the last five 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.

 

Cromos Pharma has over 18 years of experience in managing all aspects of clinical trials across a range of therapeutic areas. With operations in the US, Central and Eastern Europe we combine global expertise with profound local market knowledge to deliver end to end solutions supporting our pharma and biotech clients.

TO FIND OUT MORE

INQUIRY@CROMOSPHARMA.COM