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.