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.