Scientific support |
Protocol development |
Support to the coordinator physician within the study board, for the implementation of the ethical aspects and safety requirements of research |
Study report, publication and result dissemination |
Support to the final study report, publication submission and dissemination of the study results |
Study project management |
Study budget plan and budget negotiation |
Evaluation of study costs, budget plan development and budget negotiation with pharma companies supporters of the independent research or with partners within consortium projects |
Study feasibility |
Support to sites selection through site feasibility development within the study board |
Regulatory documentation |
Preparation of the regulatory documents, preparation and maintenance of the study binders in accordance with Good Clinical Practices and ISG Clinical Trial Standard Operating Procedure (SOP) |
Regulatory submission |
Submission to the Competent Authorities and Independent Review Boards (IRB) of the regulatory (protocols, patient’s information sheet and informed consents, Investigational Product information, safety information and all the others applicable documents) |
Support activity in the preparation of the submission package for extra-Italian submission within international studies coordinated by ISG |
Investigational Product (IP) activities |
Management of the IP from labeling (if required) to supply and resupply activities |
Database development |
Support to the Case Report Form design |
Investigators meetings |
Support in the organization of the Investigators Meetings and logistics |
Monitoring activities |
Management and conduction, either remote and onsite, of the site activation, monitoring and close-out visits |
Coordination of centralized activities |
Development of procedures for centralized activities (samples management in case of centralized biological material analysis, centralized imaging review management) |
Communication with the sites |
Study state of art continuous monitoring |
Regulatory and safety management |
Safety regulatory activities conducted by the Pharmacovigilance Office |
Communication of safety information (SUSAR, SAE line listing) to Competent Authorities and sites |
Eudravigilance reporting activities |
Educational |
Protocol training activities |
Training on GCP, regulatory and clinical operation |
Administrative |
Protocol budget plan |
Site contract negotiation |
External services contract negotiation |