Fields of interest

TEDDY offers methodological support and expertise in:

favicon 57design and development of new paediatric drug formulations;

favicon 57planning and conduction of observational studies;

favicon 57planning and design of clinical research;

favicon 57planning and development post-marketing studies and long-term studies (including PASS, PAES, RM plans, HTA reports);

favicon 57preparation of regulatory applications (PIPs, Orphan designation, PUMA, etc.);

favicon 57preparing and submission of ethical, scientific and legal documentation to the Ethics Committees and European/National Authorities;

favicon 57conduction of pharmacovigilance activities from SAEs handling to DSUR preparation and submission;

favicon 57provision of own SOPs biostatistics, data management, drug management, monitoring, quality assurance and clinical trial management procedures.

The main therapeutic areas covered are: haematology; oncology; infectious diseases; respiratory diseases; intensive care; pain; endocrinology; rare diseases; neonatology.