More than 40 people, specialised in many different areas, work at the Data Centre.
They include doctors, biologists, project managers, IT experts, data managers, statisticians and legal personnel.
The operating structure is built around a series of operational units that collaborate together at the top level to coordinate and conduct haematological clinical studies.
The Data Centre is organised as follows:
Executive Office
The Executive Office reports to the Foundation’s Board of Directors and is responsible for overseeing all the Data Centre’s activities, defining and issuing the Quality Policy, setting the objectives to be pursued and the general guidelines to be followed.
Planning, management and analysis of clinical trials
Project management
The project management unit coordinates the clinical trials and all the professionals involved. It is engaged right from the research protocol drafting stage and planning stages of the trials to organise resources and activities to achieve the goals the research means to achieve while providing appropriate risk management. It also handles the management of the necessary instrumentation, the drugs and the medical products used for the trials.
Data managers
The Data Centre’s data managers handle the collection and processing of clinical data collected during the clinical trials based on predefined quality parameters, right up to the final transfer of the data to the biostatistics unit.
Pharmacovigilance
The pharmacovigilance department monitors the safety of patients by collecting information and data on adverse events caused by the drugs used in clinical trials, recording any adverse reactions (which may be due to therapeutical errors or non-compliant uses) and providing prompt feedback to the supervisory authorities.
Monitoring
The monitoring unit oversees the progress of the clinical trials, to ensure that they are conducted in compliance with the protocol, the Foundation’s Standard Operating Procedures (SOP), the Good Clinical Practices (GCP) and the applicable regulatory dispositions.
Regulatory activities
The regulatory activities unit supervises the procedures to ensure that they are in line with the current approval regulations for clinical trials. It’s responsible for managing the study documentation and also mediates the relationship with AIFA, the Ethical Committees and the Hospitals.
Biostatistics
The biostatistics unit collects, analyses and interprets the data collected during the clinical trial. The unit is engaged in the drafting of the protocols by defining the biological parameters on which the trials are to be performed. It is responsible for processing the data, drafting reports and guaranteeing the accuracy of the results. It is also often involved in drafting scientific articles.
Health Outcomes Research Unit
The GIMEMA Foundation’s Health Outcomes Research Unit focuses on designing, promoting and managing research projects with a view to assessing the health conditions of patients suffering from haematological neoplasms and how the quality of their health care can be improved.
LabNet
All the activities and communications of the LabNet project are managed by GIMEMA’s operational coordination unit: it coordinates and monitors quality control for all labs, supports the centres with their data management and provides assistance to the web platform set up for the project.
Other activities
The following units complete and support the Data Centre’s trial activities:
- Communication
- Training
- Administration
- Secretariat
- Legal Department
- Information Technologies