Medical writing

Leading Clinical Research medical writers closely cooperate with medical experts from all therapeutic areas, statisticians, and data managers in order to implement their entire knowledge into documents that meet any needs of our clients and strict regulatory requirements.

This process follows ICH-GCP, international and/or local regulations, and appropriate SOPs and is routinely subject to our QA/QC activities.

We are able to prepare a wide range of documents related to clinical research including:

  • Clinical trial protocols and amendments for interventional and non-interventional trials
  • Clinical investigational plans (CIPs) for medical device investigations
  • Informed consent forms
  • Patient diaries
  • Information leaflets
  • Final study reports