Throughout the duration of the project, Mandava Associates offers the singular focus of a dedicated team for consistent effective interaction with study sites. Our clinical monitor is responsible for seamless communications with your organization. Some of the services that are offered but not limited to are:
Provide monitor(s) who is qualified by experience and training for a given project Assure investigator meets general responsibilities listed under 21 CFR Evaluate and make recommendations regarding investigators/testing sites Conduct pre-study site inspections
acceptability of the site review the protocol and data capture forms with the investigator finalize contract/protocol assist with training of technical personnel
Site visits during the trial Spot check critical data during site visits Provide phone support for investigator questions Assist investigators with finalizing reports