Exom Group
Redefining the Way Clinical Trials are Conducted

Luigi Visani, with more than two decades of academic, medical practice, and clinical research experience, acquired keen insights into limitations, slowness, and inefficiencies concerning the traditional way of conducting clinical trials. To address these issues, he establish a new clinical research organization (CRO), Exom Group, in 2014, with the mission to transform clinical trials conduction by connecting new digital and mobile technologies, advanced methodologies and scientific expertise; to engage investigators as well as patients actively and remotely to study participation; and to simplify trial complexity and reduce costs while increasing quality and performance.

The distinctive feature of Exom's services, in line with their mission, is that they derive the value from the combination of three components: technology, people, and processes. The availability of a digital ecosystem allows the modification of inefficient traditional processes through the change of responsibilities and roles of stakeholders such as monitors and clinical researchers. "Within our digital ecosystem, stakeholders will be able to review data, identify and remediate issues, generate detailed and multi-source performance metrics while also tracking approval processes. All of these activities and resources are operating and moving within the same globally available and secure framework," explains Visani, who also heads the company as its President and CEO. Real-time and online management of clinical trials and collaboration among the study stakeholders together with the dynamic and reactive (data‐driven) nature of technologies that Exom leverages enables a new level of flexibility, control, and responsiveness. Furthermore, real‐time aggregation of activities and events provides new insight into clinical trial processes, and the meaningful presentation of this information makes it highly useful—not only consumable but also actionable.

Genius SUITE is Exom's integrated multi-modular cloud platform that enables real-time and online management of any clinical trial activity backed by the organization's expertise across medical, regulatory, and operational functions. The platform comprises a variety of tools which can be implemented on a modular as well as on an integrated basis to enhance efficiencies and process speeds while ensuring data quality and cost-effectiveness. Currently, the platform comprises 16 different modules including electronic Informed Consent (GeniusENGAGE), the Data Lake Visualization & Analytics (Genius REVEAL), the Data Driven Site Management & Monitoring (Genius RIBAM), the mobile eSource and electronic CRF (Genius MOSE), the electronic Trial Master File (Genius eTMF) and the electronic central event adjudication platform (Genius CEC). “With these modules, we tried to do what successful digital companies did—offer very high-tech high-quality services in a really flexible, transparent, fast, and reliable way at the lowest possible price," extols Visani.

Exom Group is also well experienced in conducting international, high-quality independent clinical trials across the world.

We are dedicated to modernizing clinical research through the development of novel solutions and evolving existing ones, based on the market requirements and our visions

In the case of Investigator's Initiated Trials (IITs), an investigator requires more efforts to start an IIT, in the preparation of the trial, compared to running a pharmaceutical-sponsored trial due to the limited budget. Together with its team of medical writers and biostatisticians, Exom partners with investigators to design the study protocol and helps apply for the research grant to run IITs. Exom's Genius SUITE ensures a smooth and accurate running of the IIT from protocol writing, study feasibility, submissions, management, and monitoring, to data management, and statistical analysis up to the final study report, aiding the improvement of drugs and the treatment of diseases.

Exom Group has benefited a major international study which required the organization and management of documents from hospitals to individual members of the Central Event Committee (CEC) responsible for the central blind assessment of each clinical event that occurred in the study. Exom’s Genius CEC allowed centers to upload different types of documents and images related to the event for adjudication, automatic anonymization, validation, evaluation, and resolution of assessment disagreements. More than three hundred case dossiers have been generated and swiftly adjudicated by CEC.

Exom is set to release Genius WIZARD, the data lake advance analytics application for intelligent clinical trial management that shall unify and analyze data from eleven source databases (eCRF, eFeasibility, DSM, CEC, RBM, eTMF, CTMS, PH Vigilance, Navision, QUAMM, Docebo). Besides revealing hidden trends using statistical algorithms, the solution has the potential to enhance project oversight and resources utilization, to reduce on-site visits, and more proactively address quality issues and risks than with traditional monitoring and management. The AI-powered chatbot for clinical trials, Genius ALLADIN, is under development to empower investigators to resolve queries about study protocol, procedures, accounts, training, use of SOPs, eCRF, eTMF, other study applications and/or devices. Exom is also developing Genius ROSA, a telemedicine solution for dual ways (Doctor-Patient) private, study-specific, encrypted multichannel application for remote patient’s study visits, monitoring, and support. This approach is the essential tool for the implementation of the Decentralized Clinical Trial, to allow some or all aspects of a clinical trial to be carried out at a participant's home or local physician's office, rather than at a central trial site such as a large hospital.

"Exom is constantly evolving. We are dedicated to modernizing clinical research through the development of novel solutions and evolving existing ones, based on the market requirements and our visions," states Visani. The organization recognizes the trends towards AI and remote monitoring and accordingly endeavors to achieve full satisfaction of their customers and patients, through the development and implementation of the most disruptive digital and mobile technologies. Exom's business growth strategy brings people with solid experience, expertise, and visions together and aims to establish Exom as the leading expert international CRO in digital clinical trials, providing the most innovative solutions to its clients for smoother and successful trial conduct.