We are proud to offer the best team of Clinical Research Associates (CRA) and Clinical Trials Coordinators (CTC) in Russia, Central and Eastern Europe. Our CRAs are located across Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia, Bulgaria, Czech Republic and Poland. OCT doesn’t work with freelancers.
CRAs medical background ensures protocol and regulatory compliance as well as high-quality data.
Each CRA is experienced and trained in country specific regulatory regulations, ICH GCP. OCT CRA is the first line of communication between the sponsor and investigator throughout the study.
CRAs are responsible for monitoring a site's activities throughout the clinical study, including site qualification, initiation, interim and closeout visits. OCT CRAs perform on-site monitoring as well as remote data monitoring to ensure patients’ rights protection, integrity of study data, and compliance with applicable regulations.
On-Site Monitoring
OCT CRA perform on-site monitoring. They perform an in-person evaluation of data at the sites. CRAs main tasks are:
- to identify data entry errors, discrepancies between source records and CRF, missing data in source records or CRFs;
- to provide assurance that study documentation exists;
- to assess the familiarity of the site’s study staff with the protocol and required procedures;
- to train site staff in study procedures;
- to assess compliance with the protocol and investigational product accountability;
We find on-site monitoring very important in a study, especially if the protocol is complex, and includes new procedures with which investigators are not unfamiliar.
Remote Monitoring
CRAs monitor data quality through routine review of submitted data in real-time provided that both source data and CRFs can be accessed remotely. Remote monitoring enables OCT CRAs
- to identify missing data, inconsistent data, data outliers, and potential protocol deviations that may be indicative of systemic or significant errors in data collection and reporting at a site;
- to verify source data remotely;
- to collect and archive regulatory documents;
Each project is assigned a CTC who provides administrative and operational support to the clinical study. CTCs are an integral part of our clinical team supporting clinical trials in many areas. CTCs are responsible for preparing, handling, distributing, filing, and archiving clinical documentation. They maintain study files, track and manage clinical data flow and perform administrative tasks. CTCs often act as primary contacts for the clinical team for certain aspect of a trial. Most CTCs at OCT have an English language degree.
