Feasibility for studies in all indications – collection of confidentiality agreements, preparation of the feasibility questionnaire template, collection of completed questionnaires from sites
Start-up – collecting of site’s documentation, initial submission, submissions during the study, budget and contract negotiations
Monitoring and site visits – selection, initiation, monitoring, close-out and booster visits
Creating study documentation – support in writing the protocol, informed consent form, patient’s ID card, information for patients, IMP label, purchasing the Investigator’s and Sponsor’s liability insurance
eCRF, ePRO
Preparation of templates of the logs and other study documents, preparation of „Investigator Site File”
Payments to the Investigators and healthy volunteers
Patients travel reimbursement, cashless transport of patients to the site for the visits