Site Management

Our site management group oversees the conduct of a clinical trial at the investigative site and ensures that it is conducted, recorded, and reported in adherence to the protocol, SOPs, ICH-GCP, federal regulations, guidance documents, and state and local laws and applicable policies. This group establishes and maintains regular contact with investigators, vendors, and study sites to ensure compliance and assessment of accrual rates. Our monitors review and implement monitoring plans, data anomalies, and trends, study-specific forms, and case report forms. The study monitors manage all study parameters, clinical study Start-up activities, enrollment, and data collection. They assist and/or lead efforts in protocol feasibility analysis, site identification, and patient recruitment and planning. This group facilitates the collection of essential documents from each clinical research study site and oversees the submission of serious adverse events submissions and reporting. This group independently performs centralized monitoring and conducts all on-site monitoring visits such as pre-study visits (PSVs), site initiation visits (SIVs), routine monitoring visits (RMV), and lastly close-out visits (COVs). Our team ensures site compliance by maintaining a culture of quality, accurate, and organized services.