SMO services
Through our SMO services, we provide:
- Site and Principal Investigators with qualified CRAs to assist from start up activities, through maintainance and daily clinical trial activity and patient recruitment; till study is finished, close out and documents archived;
- Sponsors to provide clinical trial site management and CA/EC submissions support.
- Site Management – from feasibility or start up till close-out and final study documents archiving;
- EC and CA submission management;
- All site logistics management;
- Site contract, expense and invoicing management;
- Site support with patient identification, enrolling and retaining patients;
- Support with scheduling patient site visits;
- Support with Safety and Adverse Events (AEs) reporting;
- Ensuring Protocol Adherence;
- eCRF completion support;
- Supporting and introducing site SOPs;
- Archiving of study documents;
- Providing site with qualified Study Nurse if necessary.