Site management
Smooth Drug Development offer services of site management organization (SMO).
Site management organisation is a network of sites, which are professionally dedicated to clinical research. Within the professional SMO network, there are sites, where studies are conducted per se and referring sites.
Upon need, SMO can provide support to sites that have the necessary patient pool, are interested in study conduct but lack the required resources and clinical research experience. During cooperation, sites are supported in establishing the quality management system, assistance in obtaining accreditation for clinical studies conduct, thorough staff training and assistance in resource management.
Inclusion of new sites enables access to target patient population and fostering enrollment pace without compromising quality.
Clinical studies at SMO network sites are performed in compliance with high quality standards of our company. Early phase studies as well as phase III-IV studies are conducted at SMO sites.
We offer site management, which includes:
- Conduct of studies at professional clinical sites, where research work is the priority
- Search, accreditation and inclusion of new sites with special populations
- Integration of quality management system including clinical and SOP training programs
- Inclusion of professional coordinators and data entry operators into study teams
- Interaction with referring sites enabling the required enrollment rate
Smooth Drug Development work as a site management organization since 2008.