monitoring team is led by an experienced Global Clinical Operations Director and coordinated by lead managers who take care, give support, and supervise every activity and the implementation of the action plans discussed with the Project Manager.
services of clinical monitoring cover…
Development of a Monitoring Plan within the parameters agreed with the sponsor through the budget proposal and service contract, detailing the applicable SOP, frequency of monitoring and specific instructions of the Project.
It includes Contingency Plans for any study timeline deviation.
Once we have got the local approvals and authorizations and meeting time and expectations of our customers, APICES monitors ensure that the investigator staff are trained and with all necessary materials to the study start and getting the agreement with the investigator for the shortest date for the first patient inclusion.
APICES has in place a complete set of tools designed for an efficient site management and study monitoring, optimizing resources and ensures keeping the study under control.