The History
The "Calculation Centre" started in the 70's at the Haematology Institute of the "La Sapienza" University of Rome, with the first data collection. The three people working there were doing a highly complex logistical job. With developments in IT still a long way off, in practice this meant manually copying patient data in order to be able to analyse it on big sheets of paper, with hand-written tables using different colours, deletions and hand-writing that was legible to varying degrees.
In the 80's it was understood that in order to analyse all that data, and to understand whether those results, which were often still quite unsatisfactory, were better or worse than previous ones, it was necessary to adopt statistical methodology. Thus the management of the Calculation Centre was entrusted to a doctor who had spent some time in the US, specialising in data collection and its statistical analysis. In a small office located in via Benevento, in Rome, on the 4th floor, he installed one of the first "personal computers" that he had learnt to use in the US. Soon afterwards, work increased out of all proportion, the first databases were set up, case report forms were designed and statistical analysis began.
In the early 90's, with seven people now working in the team, the office moved to a new premises in nearby via Forlì, Rome. A new dedicated clinical research structure was set up, which was something completely unheard of at that time.
The Calculation Centre became, then, a reference point in the coordination of haematology centres that were taking part in the ever-growing number of clinical research projects. The Calculation Centre took care of all activities necessary for the conduction of clinical trials.
In the second half of the 90's a leap forward in workflow quality took place when case report forms were computerized. The idea, at that time revolutionary, was for centres to gather patient data and enter it electronically. As you can imagine, the computerization process was neither quick nor painless, but the effort that went into it has certainly been greatly appreciated over the years. One of the added bonuses was the improvement in the quality of data, on the one hand doing away with the writing and re-writing by hand, and on the other, implementing logical controls which, whenever applicable, warn the researcher in real time of potential discrepancies in data entered.
Alongside the development of the management function, came the first collaboration with AIL (the Italian Association against Leukaemia, Lymphoma and Myeloma). The Centre, by that time a complex and expensive organisation, needed further funding in order to continue working and the Roman AIL Section undertook to fund and support it.
GIMEMA's great success, achieved particularly in acute promyelocytic leukaemia therapy trials, triggered an increase in the number of membership applications and of clinical protocols to be managed. This meant another move for the Centre, this time to the building in Via Rovigo, Rome, which underwent a complete transformation and refurbishment to professional standard following the constitution of the GIMEMA Foundation. One of its first objectives during this new phase was to obtain the necessary quality certification in relation to its activities. ISO 9001-2000 certification was awarded in 2000 and the name Calculation Centre was changed to its current Data Centre .
The continued growth in the number of projects to be managed and the adoption of a new international regulatory system (ICH-GCP), which made bureaucracy, even for non-profit research, more complex, made a reorganization of the Data Centre necessary.
In the space of a few years, the number of projects constantly increased and even the hard copy archive became barely manageable at the office in Via Rovigo. Thus, in November 2009, the offices were moved to the present location in Via Casilina 5, Rome, close to Porta Maggiore Square. Once again, this was made possible thanks to AIL, now a National Association.
The Data Centre today boasts a staff of more than 20 people, all highly professional skilled personnel, which makes it one of the best non-profit research organisations in the world.
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