The Data Centre, with a multidisciplinary staff of more than 20 people,
is the operational centre that coordinates all the Foundation’s research activities,
ensuring they comply with the international standards of best clinical practice.

History

The «Calculation Centre» was established in the 1970s at «La Sapienza» University’s Institute of Haematology, where it first began to collect data. The three people working there had a logistically very complex job. Without the computer technology that became available in later years, they would copy the patients’ data by hand and then analyse them using big sheets of paper, hand-written print-outs in different colours, with erasures and more or less legible handwriting.

In the 1980s we realised that to analyse all the information, to understand if those results, often still rather disappointing, were better than in the past, it was necessary to make a serious use of statistical methodology. Thus the management of the Calculation Centre was entrusted to a doctor, who had spent a long time in the United States, specialising in data collection and their statistical analysis. In a small office in Via Benevento, on the 4th floor, he installed one of the first «personal computers» that he had learned to use in the USA. Soon there was a  disproportionate increase in the amount of work, the first data banks and the first data collection sheets were created and the first statistical analysis were started.

In the early 1990s, with the growth of the working group, now comprising seven people, the office was transferred to a new location, in Via Forlì. An authentic facility dedicated exclusively to clinical research came into existence, an absolutely cutting-edge facility for that period.

The Calculation Centre became a reference point and coordination centre for the haematology units that had joined the clinical research projects, in increasing numbers. The Calculation Centre was in charge of all the activities necessary for the development of clinical trials.

In the second half of the 1990s there was a qualitative leap in the work flow with the computerisation of data collection sheets. It was a revolutionary concept at that time, enabling   patients’ data to be collected electronically for the centres to insert from a distance.  It is easy to imagine that the computerisation process was not simple nor fast, but the work accomplished was certainly appreciated in the course of the following years. One of the greatest added values was that of being able to improve the quality of the data, on the one hand eliminating various passages and manual transcriptions and on the other implementing logical checks that, if necessary, warn the experimenter in real time of any incongruities in the data inserted.

 

This management development also corresponded to a first collaborative action on the part of the AIL (Italian Leukaemia, Lymphoma and Myeloma Association). The Centre, by now a complex and costly facility, needed further funds in order to function and the Rome section of AIL undertook to give its support.

GIMEMA’s huge success with its research activities, in particular the treatment of Acute Promyelocytic Leukaemia, led to an increase both in applications for membership on the part of centers and in trial protocols to be managed. The Centre was thus obliged to move again, to new headquarters in Via Rovigo, where it underwent an increasingly professional transformation, also following the concomitant establishment of the GIMEMA Foundation.

One of its first activities in this new guise was to start a process to obtain quality certification of its activities.

The first ISO 9001-2000 certification was obtained in 2002 and ‘Calculation Centre’ was replaced by the current expression, ‘Data Centre’.

The continuing growth of the projects to be managed and the adoption of the new international regulatory structure (ICH-GCP), which made the bureaucratic management of non-profit research more complicated, required the reorganisation of the Data Centre.

Within a few years the number of projects was constantly increasing, and the paper archive became increasingly difficult to manage in the Via Rovigo headquarters. Thus in November 2009 the headquarters were transferred to their current location in Via Casilina 5, in the vicinity of Piazza di Porta Maggiore. Once again the AIL intervened, this time as a National Association, making all of this possible.

In 2010 GIMEMA InFormation, dedicated to professional training and scientific dissemination, was established. GIMEMA obtained ISO 9001:2008 certification for the organisation and management of events and training courses.

The certification has always been renewed over the years, a sign of the modus operandi now consolidated within the facility, recognised also at European level through the ECRIN certification, obtained in 2016.

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