Study feasibility analysis, including feasibility questionnaires and pre-study visits to possible sites
Study document review
Creation of study materials, patient cards, site newsletters, recruitment material, etc.
Collection of all site documents, such as principal investigator CV, protocol signature pages, confidentiality agreements, financial disclosure forms, etc.
Nursing services for home treatments and sampling
Investigator meetings and/or monitor meetings
Site initiation, clinical monitoring, close-out visits
Site contracting and site payments
Ongoing study document management
Maintaining up-to-date TMF and on-site investigator site files