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