We have an experienced team of regionally based monitors, all with profound clinical trials monitoring experience. Our clinical research associates (CRAs) focus on developing strong site relationships and ensure their observance to data quality, subject safety, and early issue resolution throughout the course of the trial. Complete monitoring plans are crafted to address the trial complexity and sponsor requirements, and often combine traditional monitoring visits with robust site management and remote monitoring strategies. The Clinical Research Associate of Phidea Group performs the following essential role:
- Manages and monitors the investigational sites in order to conduct the clinical trials in accordance with protocol, and in agreement with ICH GCP, current local laws and SOPs;
- Plans visits to investigational sites according to monthly planning prepared by SCPM/CPM;
- Performs the pre-trial, initiation, monitoring and close out visits at investigational sites in agreement with SOPs (Phidea Group/Sponsor);
- Provides support to Investigational sites to ensure the quality in conducting the clinical trials;
- Acts as a link between the investigational sites and the Phidea Group/Sponsor, constantly updating the SCPM/CPM about the Study Progress, difficulties or any other questions and suggesting solutions or action plans to be taken.