Comprehensive preparation of clinical trials
Study documentation preparation
Set-up of a network of consultants and experts able to completely provide or participate in creation of new documents necessary for initiation, conduct and regular termination of IIT projects (protocol, CRF, ICF, interim report, final report, etc.). Consultation of the relevant study documentation preparation (eg. clarification of the list and contents of the essential documents for “sponsors-beginners”). Active assistance with preparation of the specific documents in cooperation with the sponsors.
Set up of a network of experts and institutions able to provide services in the area of planning and design of clinical trials and studies, data management and statistical processing of data, statistical design consultation (synopsis) and design of a suitable type of data management (eCRF versus paper-based systems, digital pen, etc.). Active provision of IIT projects biometric part according to the particular projects.
Set-up of a network of available monitoring capacities, according to the interest of creation of an internal team of monitors. Consultation on optimization of monitoring of specific IIT projects (Monitoring plan). Help with identification of suitable sources of monitors. Offer of active help with monitoring according to the particular projects.
Identification of experts willing to provide consulting services in this area in the frame of CZECRIN activity. Consultation of set up of processes for appropriate ensuring of AEs/SAEs reporting and tracking. According to specific projects, the possibility of active participation in the processes of vigilance.