Safety and Medical Monitoring
At Clinexa, we ensure that we provide rigorous medical and safety oversight for our clinical trials through the involvement of expert physicians who have deep expertise in the respective therapeutic area as well as clinical trials. Based on the needs of a clinical trial, one or more of our physicians become involved early in the design of the study and development of the protocol. Our experience tells us that having early medical input from medical monitors brings significant advantages for the conduct of the study, especially creating a balance between science and practical execution of the clinical trial. Our physicians can provide advice on selecting endpoints, utilization of biomarkers and other laboratory endpoints, facilitation of Key Opinion Leader (KOL) interaction, risk identification, investigator training and education, investigator site training and accompany monitoring visit for ongoing compliance and training.
Clinexa medical monitors review SAEs, lead and support coding SAEs and writing safety narratives. The physician panel meets regularly to review participant safety data so that risks and trends are identified.
Our physicians integrate with the available medical and scientific members of the team at the sponsor side and provide 24/7 coverage across all locations where a clinical trial is being supported by Clinexa. We ensure that we have language support available as and when it is required for effective communications with investigator sites and sponsors.