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Clinical Research Process Management System

Clinical Research (CR) process management is a complex set of tasks deeply interconnected. A carefully designed ICT platform can greatly improve the overall efficiency of the whole clinical research process, provided all the critical issues are correctly addressed.

Large clinical research institutions, like university hospital, need to manage a considerable number of concomitant studies involving many different actors (sponsors, CROs, investigators, IRBs) and tasks (protocol approval, data taking, budget management, audit trails, etc.)  that must be completed according to different and sometime conflicting schedules.

Cineca has developed in recent years several ICT tools addressing various aspects of the clinical research. From this experience a comprehensive CR process management platform has been built  by Cineca currently being adopted by various institutions in Italy. The ICT platform consists in different application modules each one addressing a different aspect of the CR lifecycle, such as:

  • Local feasibility of clinical trial: submission and tracking of new study proposals and monitoring of the evaluation of feasibility.
  • Support to IRB: workflow management of protocol evaluation process, organization of board meetings and dematerialization of IRB documents.
  • Budget, costs and billing: estimation of budget and costs, evaluation of reimbursement by sponsor, monitoring costs and profits in the course of the study, supports billing according to budget, tracking down of payments and management of research funds.
  • CR monitoring and safety: monitoring study progress and status, enrolled patients, patient’s visits and completed activities, study closure, results and publication, safety information (SAE/SUSAR/DSUR).
  • Audit trail and document management: complete management: complete management of documents, metadata and versioning.
  • Tracking of experimental drug / devices handling: complete tracking of experimental drugs, monitoring of the burden costs to pharmacy.

Finally, all data and metadata collected by the suite feed the clinical research monitoring dashboard and the Institution’s Research Portal, allowing understanding the key factors most influencing the global CR process to both investigators and decision-makers.

Fig.: Solution map

  • Università Cattolica di Roma - Policlinico Gemelli.
  • Regione Veneto: piattaforma regionale per tutti i Comitati Etici e i Nuclei di Ricerca Clinica della Regione.
  • Azienda Ospedaliera Universitaria di Padova e Istituto Oncologico Veneto.
  • Comitato Etico Area Vasta Romagnola e IRST di Meldola.