Medical Monitoring

Medical Monitoring is the one of the main points for ensuring the success of the clinical study. Our medical monitors and CRAs are licensed physicians, with strong competence in the field of international and local regulations, as well as with deep knowledge of ethical and scientific standards. They have excellent communication skills which allow us to ensure support and commitment of the site staff to collaborate and ensure compliance to the requirements of GCP, regulatory authorities and sponsors. Our CRAs enjoy their profession, and this is reflected in all interactions with clients, colleagues and site staff. 

 We provide the following services:

• Site selection, initiation, and routine monitoring, close-out
• Site personnel training and guidance
• Medical and technical support of the sites during the study
• Study documents review
• Source data verification
• Review of accessibility and eligibility of subjects
• Resolution of queries with the sites
• Preparation of site visit reports and all required documents
• AE and SAE reporting and following up
• Drug accountability