Exom Group is a globally acting full-service CRO committed to modernizing clinical trials through the combination of professional expertise with innovative digital solutions. The team came across the idea by looking at the market potential for cutting-edge digital technologies in clinical research.
In 2014 the life-science industry started using new technologies to improve patient outcomes and decrease costs, but it was far from using its full potential. As was already widely the case in many industrial and economic sectors, unfortunately, in the world of clinical research, the digital revolution was just beginning and was regarded with much skepticism. Therefore, in 2014, the adventure of introducing digital solutions to and re-engineering the clinical research processes began. Exom Group felt that the industry should begin adopting these technologies and therefore started looking for a way to conduct clinical studies in a better, more streamlined way for the clients in the first step. The digital ecosystem they created for such a revolution is Genius SUITE, a multi-modular platform that provides solutions for every single step in a clinical trial. The suite supports the study team, the sponsor, and site staff in performing their daily tasks. Since then, Exom Group has constantly been looking for new ways to improve clinical trial conduction for all stakeholders.
Exom Group was founded in 2014 by a team of entrepreneurs and scientists who were committed to developing technologies that could improve people’s lives involved in clinical trials worldwide through innovation and discovery. Exom Group has always had a focus on innovation and technological advancement and has kept its eye on what’s new, what’s next, and how to stay ahead of the curve to provide solutions for client’s needs before they even know it themselves. Today, Exom is working with some of the world’s largest pharmaceutical and biotech companies on their most important projects.
Meanwhile, Exom has received several awards, and its success can be attributed to its ability to adapt quickly as new technologies emerge. For example, Exom was one of the first CROs in the industry to offer virtual or decentralized clinical trials – a project that required significant investment but paid off with increased efficiency and lower costs for clinical trials.
Exom has managed to achieve the tenacity to deliver well and consistently to the customers by constantly striving for excellence in everything it does. They are committed to meeting deadlines, delivering high-quality work, and providing excellent customer service. This commitment has helped to develop a reputation for being reliable and trustworthy with its clients. The factor that gives the edge is a deep understanding of the clinical trial processes from a CRO perspective. Since Exom is not a technology company but a full-service CRO, it can develop and implement new technologies with the expertise of its operational departments in the background. This advantage enables it to provide clients with an incredible, unique study experience.
“There has been a growing trend in decentralizing clinical trials in recent years. Especially during the COVID-19 pandemic, the industry quickly adopted this approach. Exom was at the forefront of implementing a decentralized clinical trial approach.” Says Luigi Visani, President & CEO of Exom Group. But Exom is not only utilizing telemedicine to perform study visits at patients’ homes, but it uses the data collected in real-time to mine it for signals of effectiveness, compliance, or safety using our advanced analytics solution, Genius WIZARD. Another trend is the implementation of synthetic or external control arms (ECA) in clinical trials. The idea behind external controls is that it provides more information about how well treatments work, which can be used to compare different treatments. Some people also believe that this method will help reduce bias in clinical trials because the findings will be less likely to reflect just one group or demographic. Using ECAs makes it possible to reduce the sample size and increase patient retention, as the risk of receiving a placebo is significantly reduced.
The innovation is often triggered by a human error or by a complaint from one or more stakeholders. This situation stimulates the search for solutions, including technological ones that can support the various stakeholders in their specific activities, reducing the risk of error to a minimum and increasing their efficiency. One example is the introduction of electronic informed consent, which not only improves the patient’s understanding of the study characteristics and procedures but also avoids many of the severe errors that sometimes occur in the traditional consenting process. With Genius SUITE, Exom has developed a comprehensive range of applications that offer solutions for every single step of a clinical trial and allows processing and analyzing study data in real-time using our advanced analytics software, Genius WIZARD, based on SAS Viya 4.0. To give an example: As mentioned above, the decentralization of studies is gaining more and more importance in the industry. Of course, various providers offer telemedicine solutions. Exom has a significant advantage over the competitors here. Not only does it offer a fully integrated telemedicine solution for customers that connect directly to the EDC, eICF, ePRO, and other modules. Exom also leverages the data generated in real-time from the patients with advanced analytics solutions to detect early efficacy or safety signals to gain deeper insights into the study while it is running.
First, Exom is constantly striving to provide clients with the best possible service, and has always been committed to excellence and quality in all aspects of the company. Second, it has a strong team of people dedicated to the company and its vision, constantly updating their knowledge and skills to stay on top of new trends in the industry. Third, Exom believes that it can offer more than its competitors because Exom can not only provide technology or CRO services but the combination of the best of both worlds. Software developed from clinical trial experts and with significant expertise in managing clinical trials for years. Fourth, Exom thinks it is essential to be transparent with clients. Exom ensures that every client knows what they need before signing on, so there are no surprises down the line. Exom Group has a culture of innovation and excellence. All employees have a digital mindset, which helps improve the efficiency and effectiveness of clinical trial processes and ensures that the trial’s integrity is maintained by reducing human error. Exom Group provides all its employees with opportunities for growth and development through training sessions on various topics that help develop our employees’ skills, knowledge, and understanding. The company also ensures good communication between management and staff by conducting regular meetings to discuss important work issues. This culture translates into satisfied employees that can serve clients better by providing them with the best possible service, the highest quality data, and competitive timelines and prices.
EXOM GROUP IS THE FIRST COMPANY ABLE TO UTILIZE REAL-TIME DATA FROM DECENTRALIZED TRIALS WITH ADVANCED ANALYTICS TO PROVIDE DEEPER INSIGHTS INTO THE STUDY (SUCH AS EARLY EFFICACY SIGNAL DETECTION, PATIENT SAFETY OVERSIGHT, ETC.)
Exom Group is the first company able to utilize real-time data from decentralized trials with advanced analytics to provide deeper insights into the study (such as early efficacy signal detection, patient safety oversight, etc.) Since its foundation, Exom has already been present in Italy (HQ) and Germany. In September 2021, Exom became part of the NEUCA Group, more specifically Clinscience, the CRO of NEUCA. This merger already gave us access to additional countries, such as Poland, Romania, and Spain. Recently Clinscience set up an entity in the USA that is currently starting operations. In addition to Clinscience, NEUCA Clinical Trial Division includes PRATIA, a network of about 100 clinical research centers distributed in many European countries fully committed to perform clincal trials in many therapeutic indications. Utimately Clinscience, is planning new acquisitions in attractive markets to start an operation.
In a large international oncology study involving more than 150 clinical sites in 17 countries and randomizing more than 1200 patients, with the support of technologies, Exom were able to complete the statistical analysis within 20 working days from LPLV, including more than 3,500 AEs and 15,000 concomitant medications reported and coded as well as more than 1,200 clinical events reported and adjudicated by the Central Endpoint Committee. Exom is currently conducting a study on a Covid-19 vaccine in which recruitment took place over less than two weeks. All subjects reported every symptom they experienced daily for seven days via an electronic diary accessible by smartphone. EXOM DOES, where “DOES” means Digital, Operational, Efficient and Sustainable.