Clinical Development

The Department of Clinical Development deals with the identification of strategies and the realisation of clinical studies regarding chemical molecules that have the potential to significantly improve current therapies.

In particular, the Department identifies strategies for the evaluation of the efficacy and tolerability of the compounds and handles the relative operative phases in order to obtain the regulatory authorisations that enable them to be used in oncological patients.

The department employs a total staff of more than 50 scientists with vast experience in the clinical development of various types of anticancer agents (hormonal, chemotherapeutic, molecular targeted therapies and supportive therapies).

Clinical Development comprises five integrated units:

• Clinical Research
• Biostatistics & Programming
• Clinical Operations
• Clinical Data Management
• Pharmacovigilance

The professional and support staff hold educational qualifications of the highest standards in the business. Practices in place and supporting infrastructures and systems are comparable with those applied in the largest pharmaceutical companies and allow the development and submission of original compounds in a worldwide setting.
Personal within the department consists of staff with long-standing industry experience in the registration and life-cycle management of new drugs, in particular anticancer agents, and a proven track-record of IND/CTA filings and NDA/MAA approvals.

At the present time the Group is coordinating some 20 clinical trials (Phase I and Phase II) that are being conducted in 13 Countries.