Publication Assistance

MC-RWE >Publication Assistance

Publication Assistance

With MC, publish flawlessly

Medical/Scientific writing involves preparing scientific documentation, which comply with regulatory, journal, or other guidelines in terms of content, format and structure. With our team of expert medico-scientific writers, we offer:

  • Protocol and informed consent documents
  • Investigator brochures
  • Patient safety narratives and clinical study reports (CSRs)
  • Clinical summary and clinical overview documents for e-CTD (electronic common technical document) submissions
  • Non-clinical summary and non-clinical overview documents for e-CTD submissions
  • New drug application (NDA) and investigative new drug application (INDA)
  • Development safety update reports (DSUR) and periodic safety update reports (PSUR)