Custom e-CRF for clinical trials


The Catholic University of the Sacred Heart of Rome (Università Cattolica del Sacro Cuore di Roma) is an important campus and clinical research center.

In 2011 the Institute of Clinical Infectious Diseases of the Catholic University decided to conduct a clinical trial for a specific combination of drugs, named GUSTA. Clinical trials are normally outsourced to specialised companies (the so-called CRO or Contract Research Organizations) which offer the complete management of the entire trial process, from the completion of bureaucratic procedures to the setup of a custom support software application (called e-CRF). 

The GUSTA trial, however, was not sponsored by any pharmaceutical company and therefore its budget was too tight to allow such kind of outsourcing. In order to execute the trial internally, the Institute needed a custom software application to record all the clinical data gathered during the three years planned for the study. The software had to be developed within a few weeks, and it had to be extremely reliable and safe.

Using the Livebase platform, the Data Manager appointed by the Institute implemented and put into operation in just one week a small e-CRF system tailored to the specific needs of the gusta trial, managing all the relevant information about patients (history, symptoms, adverse events) visits, examinations (vital signs, urine, ultrasound, DEXA and bone metabolism, neuropsychologists tests), therapies and medications.

This way the Institute could immediately start the study without any initial investment, save considerably on non-essential ancillary services and leverage existing in-house skills. The total cost of the Livebase solution (platform usage during the three-year trial + time spent to configure it initially) has been estimated as a small fraction (about 30%) of what a CRO would have charged just for the usage of its own e-CRF solution.