Unit of Biostatistics, Epidemiology and Public Health
Department of Cardiac, Thoracic, Vascular Sciences and Public Health
University of Padova

Via L. Loredan 18 – 35131 Padova (edificio 00250000)
Director: Prof. DARIO GREGORI

Management Secretriat:  dott.ssa Cristiana Vettori
tel. 049 8275382
segreteria@ubep.unipd.it
cristiana.vettori@ubep.unipd.it

Didactics and Postgraduate School : dott.ssa Cristiana Vettori
tel. 049 8275382
didattica@ubep.unipd.it
cristiana.vettori@ubep.unipd.it

Masters: dott.ssa Angela Bigi
tel. 331 2602232 – 1668
masters@ubep.unipd.it
angela.bigi@ubep.unipd.it

SCTB –  Clinical Trials and  Biometrics Service

Director: Prof. Dario Gregori

Via L. Loredan 18 – 35131 Padova – tel 049 8275646 e-mail: sctb.admin@ubep.unipd.it

The Service for Clinical Trials and Biometrics (SCTB) integrates training activity, methodological development, research activity and teaching, with the activities typically carried out by the promoters of clinical research projects or by organizations that manage clinical trials in the name and on behalf of the promoters. It deals with the coordination and management of projects in their entirety or specific activities or functions, from clinical trials, to clinical investigations with pre-market and post-market medical devices, to interventional studies and observational studies in wide specialized clinical fields, including those related to the field of application of nursing, epidemiology and health in general and studies on supplements, nutrients, foods and foods for special purposes.

SCTB deals with fund rising, grant application, study design, thus ensuring a scientific and management coverage that also includes administrative, contractual, fund management, data and results reporting aspects, from the conception of the research project to the publication of the results. SCTB supports the design of clinical and non-clinical research projects, revises or drafts research protocols according to international standards, designs and builds data collection systems (case report forms – CRF – also electronic – electronic data capture - EDC) adapted to the applicable national and international legislation, but also deals with GCP training, regulatory management of clinical trials, management of pharmacovigilance activity, also in the field of EudraVigilance.

SCTB advises on the different aspects related to clinical research in the fields of data management and protection of privacy, risk management and pharmacovigilance, as well as in aspects related to the application of ethics to clinical research.

SCTB also deals with the production of standalone surveys or related to research projects, systematic literature reviews and standalone or instrumental metanalyses to the definition of clinical and non-clinical research projects as well as in support of the production of guidelines and consensus conferences.

Other services:

UBEP has and offers advanced integrated IT services such as Microsoft Azure cloud services, including reserved storage space for its members (OneDrive) and the entire workgroup (SharePoint), personal, group and lab email, personal and shared calendar, automatic authentication to services, and connected computers (including Desktop, Laptop, and server). In addition to this, hosted on Unity's Azure platform, virtual machines are enabled and activated for dedicated jobs and services, such as from MySQL data management servers, to the backend of Web sites and services, to high-performance computing for Deep Learning. In addition, UBEP also has five on-premise servers, 4 of which dedicated to internal users for RAM-optimized computation (up to 32 GB RAM per core, up to 16 cores per server). The other one (96 GB RAM x 16 cores) is devoted to R code development through an installation of the dedicated IDE RStudio Server Pro server and the computational backend of R-Shiny applications developed by the group and publicly available from the portal https://r-ubesp.dctv.unipd.it/.

Moreover, UBEP provides the possibility of creating (from scratch or models) personalized surveys or electronic case report forms (e-CRF) aimed at implementing electronic data capture (EDC) for clinical research, both for patient-reported outcomes and clinician-reported outcomes, with its deep expertise in managing REDCap.

REDCap (Research Electronic Data Capture) is an electronic data capture tool hosted at the Department of Cardiac-Thoracic-Vascular Sciences and Public Health. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources. The system is validated and it is compliant with FDA 21 CFR part 11. The data transmission is encrypted with a secure socket layer (SSL) technology and all changes to data are logged with a computerized timestamp in an audit trail.

•   LEMBS – Epidemiological Methods and Biostatistics – Coordinators Prof. Ileana Baldi e Prof. Dario Gregori

Via L. Loredan 18 – 35131 Padova – e-mail: dario.gregori@ubep.unipd.it

The laboratory deals with the development of statistical methodologies applied to biomedical research. Priority themes of LEMBS are causal models and propensity scores methods, non-standard survival models and modeling for longitudinal and related data.

•   LACED – Clinical Epidemiology and Digital Health – coordinator Dott.ssa Giulia Lorenzoni

Via L. Loredan 18 – 35131 Padova – e-mail: laced.admin@ubep.unipd.it

Il Laboratory of Clinical Epidemiology and Digital Health rappresenta il riferimento in UBEP per l’epidemiologia clinica. Le attività del laboratorio sono finalizzate allo sviluppo scientifico e alla consulenza riguardo la progettazione e conduzione di studi clinici sia osservazionali che sperimentali, l’analisi di dati clinici con tecniche all’avanguardia, la pianificazione e la realizzazione di revisioni sistematiche e meta-analisi.

The Laboratory of Clinical Epidemiology and Digital Health is the contact point for clinical epidemiology in UBEP. The laboratory’s activities are aimed at scientific development and support to the design and conduction of observational and experimental clinical studies, the analysis of clinical data with state-of-the-art techniques, the planning and implementation of systematic reviews and meta-analysis.

For what concerns study design, the laboratory has specific expertise in advanced clinical trial design, e.g., using adaptive approaches. Concerning data management, the Lab provides the opportunity of managing the data collection using non-traditional tools, such as wearable commercial devices. Regarding systematic reviews and meta-analysis, the lab is involved in several activities ranging from the drafting of the protocol of the systematic review and its registration, the definition of the research strategy and its implementation, up to the data extraction for the purpose or not of meta-analysis.

All activities are carried out in the light of the latest international scientific evidence in the field thanks to a constant updating and in accordance with current regulations.

•   LAIMS – Artificial Intelligence for Medical Sciences – coordinator Dott. Corrado Lanera

Via L. Loredan 18 – 35131 Padova – e-mail: laims.admin@ubep.unipd.it

The Laboratory of Artificial Intelligence for Medical Sciences is the reference in UBEP for internal and external study, development, and consulting for applications of advanced data analysis techniques such as data-driven self-learning procedures (machine learning) in clinical settings. Working with both traditional and deep models (DeepLearning), the interest, analysis, and management of the processes focuses on both structured (tabular) and unstructured (e.g., text, images/video, signals) data. In addition to advanced models of analysis, LAIMS deals with developing applications and Web services (ShinyApp) to interface the models themselves, both for internal and external use, both with public and restricted access. LAIMS reserves special care and attention to respecting best practices in terms of versioning and traceability of the source code developed and the isolation of the development and running environments in which the models operate. The main goal in that direction is to ensure reproducibility to the state-of-the-art in accordance and favor of the GCP (Good Clinical Practice) and the indications and recommendations of regulatory bodies on the application of artificial intelligence systems and machine learning models for clinical studies and environments.

•   LaSER – Health Service Research – coordinator dr Matteo Martinato

Via L. Loredan 18 – 35131 Padova – e-mail: laser.admin@ubep.unipd.it

The Laboratory of Health Service Research is the reference inside UBEP for performing research concerning the activities and performance assessment of the Health System, with relevant implications for Public Health. In this context, the Laboratory is designed to cover a multidisciplinary field of research on the use, costs, quality, accessibility, delivery, organization, financing, and health-related outcomes of health services. LaSER is aimed at increasing the knowledge and understanding of the structure, processes, and effects of health services on individuals and populations. The Laboratory, therefore, has the main objective of producing knowledge on the structure, processes, or effects of health services in collaboration with operational structures of the National Health Service, both inside and outside the hospital, and works in close connection and collaboration with nursing and medical staff of the involved services.

•   LESE – Ecological Statistics and Environmetrics – coordinators Prof. Cristina Canova e prof. Dolores Catelan

Via L. Loredan 18 – 35131 Padova – e-mail: lese.admin@ubep.unipd.it

The Laboratory of Ecological Statistics and Environmetrics is the reference in UBEP for studies investigating the relationship between air pollution and human health. Starting from the exposure assessment, carried out thanks to the close collaboration with the national Regional Agencies for Environmental Protection and Prevention (ARPA), the LESE aims to design, plan and conduct epidemiological and health impact studies on the effect of several air pollutants on human health using advanced statistical techniques.

•   LESEXP – Statistics in Experimental Sciences – coordinator Dott. Luca Vedovelli

Via L. Loredan 18 – 35131 Padova – e-mail: lesexp.admin@ubep.unipd.it

The LeSEXP laboratory is the UBEP reference lab for in-vitro, in-vivo and biology/physiology experimental studies involving both animal and humans.   LeSEXP encompasses a range of expertise from study design, feasibility assessment and data analysis using state-of-the-art statistical techniques. In addition, the laboratory is also involved in the analysis of "omics" data such as metabolomics, proteomics and genomics.

TEACHING ACTIVITY

•   Postgraduate School in Health Statistics and Biometrics for doctors and non-doctors – Director Prof. Dario Gregori, e-mail: specializzazione.statisticasanitaria@ubep.unipd.it

•   Curriculum in “Biostatistics and Clinical Epidemiology” nel PhD Course in Traslational Specialistic Medicine “G. B. Morgagni” – Coordinator Prof. Dario Gregori, e-mail: phd.morgagni.dctv@unipd.it

•   Master:

  -    Biostatistics for Clinical Research and Scientific Publication – First grade – Director Prof. Dario Gregori, e-mail: biostatisticarcps.dctv@unipd.it

  -    Advanced Biostatistics for Clinical Research – second grade – Director Prof.ssa Paola Berchialla,  e-mail:  biostatisticaarc.dctv@unipd.it

  -    Pharmacoepidemiology and integrated care evaluation – second grade – direttore Prof.ssa Cristina Canova, e-mail: masterHRP.dctv@unipd.it

  -    Machine Learning and Big Data in Precision Medicine and Biomedical Research – second grade – Director Prof.ssa Barbara di Camillo, e-mail: machinelearning@ubep.unipd.it

  -    Geostatistics for the health of humans, animals and the environment - Director Prof.ssa Dolores Catelan, e-mail: geostat@ubep.unipd.it

  -    Synthesis of Empirical Evidence and Research Reproducibility - Director Prof.ssa Ileana Baldi, e-mail metanalisi@ubep.unipd.it

  -    Data Omics Analysis– Director Prof.ssa Laura Ventura e-mail: datiomici@ubep.unipd.it

EDUCATIONAL SPACES

•   LEMBS Room- 00 250 00 013 basement floor north wing - capacity 15 seats, equipped with projector, laptop and IWB (multimedia interactive whiteboard), usable for seminars, meetings and video conferences

•   REGISTRATION Room 00 250 00 016 basement floor north wing - for video recording, lessons and courses