Precise Clinical Trial Documentation

It takes specific expertise, training, and experience to craft the documents that support your clinical trials. Our team of technical medical writers brings flexibility, competency, and consistency to your writing and publishing projects. Not only do we meet your deadlines, but we provide high-quality deliverables in a cost-effective approach.

Services

  • Study protocol writing
  • Clinical trial application writing
  • Clinical study reports writing
  • IMPD writing
  • CER reports
  • Management and writing of region-specific Module 1 documents
  • Scientific manuscripts
  • Support pharmacovigilance in the preparation of RMPs, DSURs, PBRERs, and annual safety reports
  • Writing of Modules 2.5 and 2.7, ISS, ISE, and response documents