Healthcare & Pharmaceutical Awards 2021

22 GHP / Healthcare and Pharmaceutical Awards 2021 , Jul21316 Exom is a globally acting full-service CRO committed to the modernisation of clinical trials through implementation of innovative digital solutions. We find out more about the firmand its recent success fromDr Luigi Visani. Clinical Trials Virtualisation CRO of the Year 2021 Exom was founded in 2014 in Milan, Italy, as a digital, full-service CRO providing clinical trial services to the pharmaceutical, biotech and medical device industry from phase I - IV. The goal of its founders was to make the conduction of clinical trials more efficient by utilising innovative technologies. By combining the expertise of clinical project managers, data managers, and monitors with advanced technologies, the ultimate aim was to shorten study timelines, improve the quality and make clinical trials more cost-effective. “Our mission is to enable sponsors to conduct more cost-efficient studies, shortening the time-to- market with a high study data quality and patient safety,” explains Dr Luigi Visani. “We empower patients who previously could not participate in trials to do so now. Real-time patient data can be collected via telemedicine at home, giving sponsors even more in-depth insights into health status and enabling earlier detection of signals via advanced analytics.” To reach this goal, Exom began developing the Genius SUITE in 2014 after establishing its business as a CRO. Genius Suite is a multi-modular cloud- based platform of tools to support project managers, investigators, monitors, sponsors, and patients, putting study stakeholders in the centre of a clinical trial. “Our data-driven study management approach enables a new innovative monitoring strategy saving up to 50% of the monitoring cost,” elaborates Dr Visani. “Additionally, the advanced analytics platform, Genius Wizards, allows for the early detection of signals in early phase clinical trials, leading to a science- led decision on continuing product development or not. It is also possible to decide at the earliest possible stage in which direction product development should continue.” In 2015, Exom started its operational business as a full- service CRO, managing its first large-scale clinical trials in the area of oncology, CNS, and cardiovascular diseases. On an ongoing basis, Exom developed new solutions that complemented their Genius SUITE. Among others, Genius EVA (Exom Virtual Assistant) was introduced, which is an interactive task list for investigators. Genius EVA allows investigators to identify which activities are important by colour code and gives them direct access to the appropriate item without tedious navigation through different systems. “Exom aims to strengthen its position as one of the leading CROs in digital and virtual clinical trials. To this end, we want to break new, innovative ground that others have not yet found. An essential point in this context, in addition to expertise, is undoubtedly the development of new technologies and the further development of existing solutions.” True to its commitment to improving clinical trials for all stakeholders, Exom ventured into implementing telemedicine in clinical studies, putting patients at the centre of the study. Exom’s goal was to break down geographical barriers by utilising telemedicine, enabling patients with rare diseases, located remotely, or those unable to travel to participate in studies. Another advantage that telemedicine brought was the real-time availability of clinical data, which could be collected from patients at home. This combined with Genius Wizards, an advanced analytics tool developed in 2019 in cooperation with SAS Institute, allows early detection of signals in clinical trials, making them safer and more efficient. In 2019, Exom started developing its third iteration of the electronic Informed Consent, Genius ENGAGE. It should become the first eICF in Europe that allows investigational sites to educate patients and obtain consent remotely. An advanced signature via cloud certificate enables a clear identification of the study participant. Full integration with other Genius Suite modules, such as the eCRF and eTMF, enables a streamlined workflow from ICF creation and use of the last approved ICF to automatic patient creation in the eCRF after successful consenting. 2020 was a year with some significant milestones achieved as the pandemic put Exom in a position where clinical trial management required many innovative approaches. One of the biggest challenges was to ensure continuity of ongoing clinical trials, even when monitors were no longer allowed at the trial sites to verify source data. Here, Exom could leverage existing solutions, such as the electronic site file and the drug accountability tool, and complement them with a newly developed platform, Genius SITE VAULT. “Exom was founded with the aim to utilise innovative digital solutions for managing clinical trials. Therefore, unlike many competitors, Exom was well prepared for the pandemic situation, as it has already developed, established, and was already using highly dedicated digital solutions for managing clinical trials.” Receiving the title of Clinical Trials Virtualisation CROof the Year 2021 in the Healthcare and Pharmaceutical Awards is testament to the fact that not only does Exom have the required technological infrastructure and expertise, but the mindset of its employees is of substantial importance when using digital technologies to make clinical trials more efficient. “Exom continually strives to stay ahead of the competition and is continuously looking for ways to run clinical trials more efficiently to provide a one-of-a-kind trial experience. “True to its mission, Exom will always stay at the forefront of innovating clinical trials, becoming a market leader in digital clinical trials in the CRO industry.” Contact: Dr. Luigi Visani Company: Exom Group Srl Web Address: www.exomgroup.com