As an interface between physician and clinical trial, our Flying Study Nurses create a professional GCP/ICH infrastructure to carry out high-quality clinical studies according to international standards in doctors’ offices and hospitals without their own clinical research department.
How do they do it? By taking on the role of study assistants in a project-related manner and adapted to the respective requirements of the study and the local conditions. This includes work on and with patients as well as administrative and logistical activities. They can be deployed nationwide and, thanks to their subject-specific knowledge of English, can even participate in international studies.
The Invisio Flying Study Nurses assist you by, among other things
- coordinating smooth communication and interaction between you, the sponsors, the CRO and the authorities at all times and ensuring that questions are answered promptly and the resulting work steps are initiated without delay.
- professionally preparing all documents required to submit a study.
- archiving – together with you – all relevant data and documents in a protocol and ICH/GCP compliant manner.
- monitoring the contractual payment of the investigator fees and reimbursement of any study-related expenses.
- organizing site initiation visits (SIVs), monitoring visits (MVs), site audit visits (SAVs) and site close-out visits (SCVs) at the trial centers in cooperation with the sponsor or the responsible CRO while ensuring that all persons concerned are present.
- preselecting and coordinating suitable patients, thus ensuring the recruitment process allows the study to be conducted with the planned frequency.
- coordinating, preparing and following up patient visits and ensuring they comply with protocol and ICH/GCP.
- shipping “biological samples” as well as other centrally evaluated parameters in a technically correct manner and ensuring the reliable and electronic transmission of data.
Eager to learn how the Invisio Flying Study Nurses can assist you? Feel free to contact us.