Medical Writing

KlinEra’s existing skilled medical writing professionals design and prepare a wide range of Good Clinical Practice (GCP) compliant pharmaceutical documents that are needed for achieving regulatory approval.

Our medical writers include specialists with medical expertise and scientific backgrounds which offer our clients the flexibility and efficient process for any size project, including:

  • Clinical development plans
  • Clinical trial protocols
  • Clinical study reports
  • Informed consent forms
  • Adverse drug reaction (ADR) reports
  • Application documents

All documents are prepared according to the ICH guidelines and meet FDA and local requirements.