In 2003, the Clinical and Evaluative Epidemiology SSD started an activity with the support of the Compagnia di San Paolo. Over the years, it has progressively developed with the aim of providing methodological and instrumental support to clinical research groups through collaboration in the design, conduct, and analysis of clinical studies,, prioritizing non-commercial spontaneous studies. In 2016, the SSD was entrusted with the design and coordination of the Clinical Trial Center at the corporate level, and in 2018, the coordination of the Clinical Trial Quality Team,, as required by AIFA for non-profit clinical study-promoting institutions.

Objectives

The web application EPICLIN aims to manage all phases of registration,, randomization, data collection, monitoring,, and the preparation and storage of databases for statistical analysis of clinical studies, especially multicentric ones.

Methods

The EPICLIN site was internally designed, developed, and managed by the SSD's team of IT professionals, in close collaboration with other figures involved in clinical research (statisticians, data managers, researchers) and under the supervision of clinical epidemiologists.

The utility and functionality of this application have been consolidated over time, thanks to continuous software updates and adaptation to cybersecurity requirements and compliance with regulations on clinical studies and data protection.

The site provides dedicated work areas for each research project, with a highly customizable modular structure, accessible only to authorized users, utilizing shared functionalities and interfaces based on a core software.

In particular, the web application allows you to:

• administer user access control to confidential information and assignment of operational rights to data;
• collect data via web (electronic Case Report Forms - eCRF);
• realize data collections with high capacity for extension and adaptability based on the study design and objectives;
• automate the patient recruitment process by assigning unique anonymous identification codes and securely controlling the entry of clinical data;
• validate data quality through automatic server-side checks;
• facilitate monitoring activities during studies through dashboards, production of custom queries, and automatic email sending;
• report serious adverse events and toxicity in real-time;
• trace and easily understand every creation, modification, or deletion activity of the data (audit trail);
• protect and preserve recorded data according to high-security standards and in accordance with current privacy regulations.

Also guaranteed are:

• availability of applications in multiple languages;
• continuous maintenance service for the web application and 24/7 operation of the hosting server;
• telephone and email assistance to users;
• information security through adopted technologies, secure data transfer, and frequent data backups.

Results

The first version of the EPICLIN site, online since May 2004 and subjected to several updates, has been used for data collection in numerous clinical studies (over 50), mostly experimental.

Currently, the EPICLIN platform hosts several trials promoted by the Fondazione Italiana Linfomi (FIL), structures of the Oncological Network of Piedmont and Valle d'Aosta, and other research groups, mainly in oncology and hematology.

Overall, over 1000 users have been accredited in approximately 400 hospital facilities.

In collaboration with the Fondazione Italiana Linfomi, the team has also developed an application dedicated to the complete management of information related to pharmacovigilance (Drug Vigilance) required during the conduct of clinical trials.

Web-based data collection is now the standard solution for clinical studies and requires constant updating to seize improvement opportunities offered by the evolution of information technology and to comply with the stringent requirements of regulations and quality standards for such tools.