We have a strong track-record in providing high quality and cost effective site management services, and this is one of our key differentiators vs. other CRO’s on the Romanian market. Qualifying sites was a continuous area of attention for us over time, therefore we know and can recommend the most effective sites over the country in terms of rapidity of start, enrollment rate performance, staff responsivity and effectiveness etc. Our site managers are located in several regional hubs country-wide, thus ensuring long-standing relationships with Investigators, high reaction speed, and costs minimization. We developed dedicated site management SOP’s, revised and up-dated periodically, thus offering a consistent and sustainable basis for high quality clinical data output to our sponsors.
WHY SITE MANAGEMENT?
- Study teams are usually understaffed and/or they conduct several studies at the same time. Therefore, in most cases, investigators need additional support
- Administrative aspects are often perceived by investigators as the most unpleasant part of the study and therefore treated with less attention
- CRFs and other documents completion is seen as time consuming and often postponed or done with errors if done by the study staff
- In audits or inspections, many findings are caused by insufficient attention to details and lack of time for quality control
WHAT DO WE PROVIDE?
- Site initiation and close-out procedures
- Support for patient selection and eligibility assessment (e.g. review of hospital charts & patients database, training site staff as required)
- Ensure updating and completeness of the Site Management File (SMF)
- Ensure protocol accuracy and compliance
- Periodic check and support for correct and timely completion of source documents
- Data entry on CRF/eCRF and/or assisting investigators in completing documentation
- Patient scheduling for visits on site, laboratory tests and/or other investigations
- Support site staff with safety reporting, query answers and corrective actions
- Site preparation for monitoring visits, audits and/or inspections
- Report adverse events and advise investigators about potential protocol deviations and/or regulatory problems