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

Budget management