On the field of general paediatric practicioner we deal with our own and referred patients. In studies requiring specialists we work in collaboration with specialized colleagues (e.g. ENT, pulmonology, allergology, dermatology, neurology, psychiatry, ophthalmology). We are prepared to organize studies not only in our centers but in other parts of the country, having other investigational sites at our disposal.
We are able to handle the following tasks:
1, Feasibility performance. After a pre-review the participation is discussed with the different sites. The interesting sites will participate in the sponsor or CRO site selection.
2, Preparation of material to be submitted to Local Authorities as well as the Central Ethical Committee
3, Translation of Informed Consent and other patients's material
4, Collection of required documents (CV-s, Protocol Signature pages)
5, Preparation of the contract. One contract with Futurenest network. Making subcontracts with all participants (including hospitals) is our responsibility.
6, Preparation and organisation of the clinical trial, task distribution
7, Preparation of the patient binder
8, Organisation of the local investigator meeting (preparation of the presentation needed)
9, Continuous contact with the sponsor/CRO from feasibility until data closure
In case of studies that require specialists:
1, Continous training of the specialists concerning the study, local laws and GCP
2, Help in the patient recruitment and execution of patient visits
3, Participation in monitoring visits
4, Contact with local ethical committees
5, Maintenance of study files
6, Preparation of financial documents