Biotech and pharma companies need to comply with increased regulatory requirements for paediatric trials. Yet, as per applicable regulations, companies can’t adopt their adult clinical trial outcomes for paediatrics. Trial planning, design, and conduct of a paediatric drug development study may pose many challenges, so do paediatric trials, including regulatory hurdles and specific needs for Turkey in recruiting, inclusion /exclusion criteria, subject compliance, and retention.
Paediatricians in Turkey are highly experienced in diagnosing and treating various rare diseases as well as oncological and haematological cancers in children. The experience accumulated after the birth of modern paediatrics in the late fifties in Turkey continues to have significant contributions to the international paediatric studies.
As MonitorCRO, we have substantial experience in paediatric/neonatology studies, and we are here to navigate complex regulatory pathways and fulfil requirements for your trial to be efficient and successful.