Site Management

As part of our comprehensive Site Management services, we provide full coordinator support to ensure smooth and efficient trial operations. This includes the development and execution of SOP (Confidentiality Disclosure Agreements) and protocol feasibility assessments, as well as the site selection process. We handle contract and budget negotiations, regulatory and startup document completion, and 188 submission and correspondence, ensuring all documentation is in compliance and up to date. Additionally, we manage the generation of source documents, site initiation, and subject identification, as well as overseeing subject study visits and acting as the study/site point of contact. Our services extend to study execution, monitoring visits, and ongoing correspondence. We also ensure drug and device accountability, as well as electronic data capture entry and query resolution. As the study progresses, we are responsible for study closeout, invoicing, and managing marketing and advertising efforts to ensure effective recruitment and awareness.