Early Drug Development Group clinical services team is specialized in the management of all aspects of phase I/II oncology clinical trials, from conception through to study report writing.

Our Clinical Services Include

  • Support companies by providing strong medical input thanks to our oncology-experienced staff.
  • Design of Phase I clinical studies, FDA/EMA guidance, and trials implementation.
  • On-site review of medical source documents and data validation of clinical trials and compassionate-use programs.
  • PK/PD modeling in order to propose the best dose levels scheme during early clinical studies.
  • Assistance on the preparation of a clinical development plan.
  • Recommendation of regulatory strategies to achieve expedited marketing approval and rapid adoption in the clinic.

Our broad experience ensures an extensive international network of hospitals and academic institutions.

clinical services E2DG