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