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Clinical Operations

Peachtree’s Clinical Operations team provides clinical monitoring and management of the investigative site and is the main line of communication between the sponsor or contract research organization (CRO) and the investigator. In general, there is on-site monitoring before, during and at the close of the clinical trial, but the extent and nature of monitoring are determined by the purpose, objectives, design, complexity, size, endpoints and requests of the sponsor. Thus, clinical monitoring is conducted to verify that:

• The rights and well being of human subjects are protected.
• The data are accurate, complete, and supported by source documentation.
• The conduct of the trial is in compliance with the approved protocol, with Good Clinical Practices, and with the applicable regulatory requirements.

Clinical monitoring and site management are conducted by Clinical Research Associates (CRAs), or monitors, who are knowledgeable of the protocol, the investigative product, informed consent and written information provided to subjects, the sponsor's Standards of Practices, Good Clinical Practices, and the applicable regulatory requirements.
During each visit, Peachtree Clinical Research Associates:

• Compare 100 percent of the case report forms (CRFs) to the source documents
• Review the CRFs and source documents for serious adverse events
• Perform drug accountability
• Ensure appropriate signed informed consent forms exist for all study participants
• Review investigator study files for completeness
• Ensure investigator compliance with the study protocol

Between monitoring visits, CRAs call investigators weekly to verify patient enrollment status, review study progress, answer protocol questions, discuss CRF completion and ensure the study proceeds in a timely manner.

CRAs make final visits to sites to close out studies after all subjects have completed or have been discontinued from the study and after all queries have been resolved.

Peachtree works closely with clients to identify investigator sites with a proven record in managing and overseeing clinical studies. Site management includes:

• Due diligence to help ensure that each investigator selected is qualified to perform the services required
• Collection, review and approval of all required regulatory documents for each participating investigator
• Inspection of background information, protocol, study procedures, regulatory requirement, adverse event information, enrollment rates and CRF source documentation