Challenges and Solutions for the Use of Remote Study Monitoring in a Transcontinental Project

摘要: Remote study monitoring (RSM) rather than remote data entry has been employed by Bayer in Europe and overseas over the past four years. Despite fact that starting with RSM certainly requires up-front investments, decided to apply development of Phase 2 3 a new anti-infective. The submission was filed less three years drug (Avelox®) is on market already. This paper focuses challenges surfaced while running full program 36 countries at 800 investigator sites all world. pros cons such project wide range countries, different infrastructure phone systems, languages, software experience are discussed. showed package used not necessarily limiting factor when studies RSM. Solutions were found for continuously incoming burning challenges. change company culture required due closer cooperation between parties involved clinical compound addressed. Finally, recommendations introduction pharmaceutical criteria selection proper preparation technology made.