Kuantum Cro

Clinical Research Services 1- Selection of site and investigators 2- Initiation, monitorization and close out of study sites 3- Progress reporting 4- Safety reporting and monitoring 5- Follow-up of EC and RA reporting 6- Design and production of study newsletters 7- CRA and Investigator training 8- Investigators' meeting organization 9- Financial agreement preparation for the investigators and institutions Medical Services 1- Case Report Form (CRF) design 2- Informed Consent Form (ICF) writing 3- Investigator's Brochure writing 4- Medical translation and translation control Regulatory Affairs Services 1- EC and RA applications (index and timelines) 2- IL application (index and timelines) 3- Regulatory Body negotiations 4- Preparation of revisions in collaboration with clients Regulatory Affairs Regulations