Dr. Luigi Visani, President and CEO of Exom Group Srl, Speaks to The Silicon Review: ‘Our Mission is to Stay at the Forefront of Innovating Clinical Trials and Become a Market Leader in Digital Clinical Trials in the CRO Industry’

“We continually strive to stay ahead of the competition and are looking for ways to run clinical trials more efficiently and provide all stakeholders with a one-of-a-kind trial experience.”

Exom Group Srl is a full-service Clinical Research Organization (CRO) committed to the modernization of clinical trials by implementing innovative digital solutions. With its cloud-based platform Genius SUITE™, Exom improves efficiencies and escalates process speeds while ensuring high-quality data and cost reduction, from early to late-stage and outcome studies.

Interview Excerpt: Dr. Luigi Visani

Q. When was Exom Group Srl incorporated? Brief us about the journey so far?

Exom was founded in 2014 in Milan, Italy. The goal of our founders was to make the conduction of clinical trials more efficient utilizing innovative technologies. By combining the expertise of our 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. 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 center of a clinical trial.

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. Genius EVA (Exom Virtual Assistant) was introduced, which is an interactive study task support for investigators. Genius EVA allows investigators to identify which activities are more delayed by color code and gives them direct access to the appropriate item without tedious navigation through different systems.

True to its commitment to improving clinical trials for all stakeholders, Exom ventured into implementing telemedicine in clinical studies, putting patients at the center of the study. Exom’s goal was to break down geographical barriers by utilizing telemedicine, enabling patients with rare or chronic diseases, located remotely, or 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.

As technology, data, expertise, and investment in clinical research continue to unfold, pharma’s future financial sustainability depends on the ability to utilize data-as-a- critical asset and leverage advanced analytics/cognitive approaches in decision-making processes. However, today’s standard practice of using disparate systems to collect study data makes it difficult for researchers to manage trial performance and uncover valuable insights about the treatments they are developing. This is where Genius Wizards comes into play by enabling faster processing for vast amounts of data and the most complex analytics for quicker and data-driven study management and monitoring decisions.

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. A digital 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.

The year 2020 came with some significant milestones achieved as the pandemic put us in a position where clinical trial management required many innovative approaches. One of the biggest challenges was ensuring continuity of ongoing clinical trials, even when monitors were no longer allowed to perform monitoring visits at sites and verify source data. Here, Exom could leverage existing solutions, such as the electronic site file and the drug accountability tool, and complimented them with a newly developed platform, Genius SITE VAULT.

Genius SITE VAULT allows centers and monitors to work together in a secure, fully encrypted environment, enabling the CRA to conduct remote source data verification. At the same time, all documents remain under the full control of the site. This allows full GDPR and HIPPAA compliance and reduces the risk of potential data breaches.

Q. How does Exom Group help contain the costs, reduce the time to market, face the regulatory pressures, and manage the complexity and the level of the burden in clinical operations? Describe briefly.

By implementing the next-generation clinical trial 5.0 processes, through the combination of human expertise with the efficiency of digital technologies and advanced analytics Exom provides its customers with value-added services and an exceptional study experience.

Our data-driven and risk-based study management approach enables a new innovative monitoring strategy saving up to 50 percent of the monitoring cost. 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.

Q. To streamline your process better or promote your product offerings, you must have embarked on many partnerships. If any, would you like to share how consolidations have benefited your business growth?

Why reinvent the wheel when there is a perfect and widely accepted solution on the market that integrates well with our portfolio? This is and has always been our founders’ approach. Not only in terms of software but also in selecting partners for our CRO network.

When conducting international studies, Exom uses innovative technologies to provide a centralized study oversight. Each task performed and document collected locally are recorded and filed in appropriate digital applications controlled by the headquarters and analyzed in real-time by Genius WIZARD. This approach allows the global study team to maintain an unprecedented and regular oversight of the study activities performed in each participating country and quickly implement any data-driven corrective action if needed.

This approach allowed Exom to be very cost-efficient by not maintaining unnecessary infrastructure when it is not needed. In return, overhead costs can be lowered, and in case it is necessary, the required infrastructure can be set up very quickly. Furthermore, this approach allowed us to save both time and human resources and, therefore, money to develop new software solutions for our Clinical Trial Suite.

Q. Where do you stand as a company in a crowd of competitors? And what are you doing to stay ahead of the curve?

Amidst many CROs, Exom is a company with significant experience in digital and virtual clinical trials. 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 looking for ways to run clinical trials more efficiently and provide all stakeholders with a one-of-a-kind trial experience.

Our goal is to enable sponsors to conduct more cost-efficient studies, shortening the time-to-market with a high study data quality and patient safety. 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.

Q. Briefly walk us through your plans. Where do you see your company a couple of years from now?

Exom aims to strengthen its position as one of the leading CROs in digital and virtual clinical trials combined with AI, particularly Machine Learning that can improve drug approval rates and reduce development costs and deliver medications to patients faster.

Therefore, one of the most important developmental steps in the future will undoubtedly be access to electronic health records (eSource), making clinical trials even more effective. This step will significantly reduce the monitoring effort, and entire study arms may be replaced by real-world data in the called Synthetic Control Arm to increase efficiency, reduce delays, lower trial costs, and accelerate the access of therapies to market. Our mission is to stay at the forefront of innovating clinical trials and become a market leader in digital clinical trials in the CRO industry.

"Our third iteration of the electronic Informed Consent, Genius ENGAGE, is on the verge of becoming the first eICF in Europe that allows investigational sites to educate patients and obtain consent remotely."