Luigi Visani is the President and CEO of Exom Group Srl, an Italian full-service clinical research organization (CRO) based in Milan, and specialized in providing a wide range of clinical trial management services for the biotechnology, pharmaceutical, and medical device industries.
Our conversation with Luigi will be centered on the particular advantages of executing phase I-IV clinical studies in Italy, while offering strategic counsel to biotech and pharma companies considering this country for their trials.
Patricio Ledesma (PL): Luigi, it is great to talk to you. Thank you very much for joining us in this conversation.
Luigi Visani (LV): Thanks to you Patricio for the opportunity you give me to present the features and competitive advantages of clinical research in Italy as well of Exom Group, a real innovative CRO that combines professional expertise with the most advanced digital technologies for clinical trials.
PL: Could you tell us a bit about your personal background in clinical research and how did you get in the world of clinical trials?
LV: I am a medical doctor and a cardiologist by training. After a few years spent in the clinic, because of my particular interest in drug clinical research, I joined the medical department of an international pharmaceutical company where I remained for many years as medical director. I then decided to start my own business by taking over a small Italian CRO. The latest adventure is that of Exom Group, founded with the specific aim of modernizing clinical research using the most advanced digital solutions.
PL: Italy is known for conducting a large number of clinical trials per year. By the end of 2021, the American clinical trial database (ClinicalTrials.gov) shows an accumulated amount ⸺through the years⸺ of more than 15,000 clinical studies with Italian participation, which puts Italy in the top 4 countries with more clinical studies in Europe. What are the reasons behind this great potential in clinical research by Italian sites?
LV: For decades in Italy, the National Health Service has not only been public but also free for all citizens. This model has led to the development of many high-level hospitals, not only in terms of medical care but also in terms of clinical research.
Moreover, since 1930 we have the so called IRCSS specialized in many therapeutic areas. The name of IRCCS or technically “Istituto di Ricovero e Cura a Carattere Scientifico” indicates biomedical institutions of relevant national interest, which drive clinical assistance in strong relation to research activities. Their mission is the continuous upgrade of healthcare. The IRCCS title is granted by the Italian Department of Health to a limited number of institutes throughout the nation. As of today there are 51 IRCSS in Italy. They are committed to be a benchmark for the whole public health system for both the quality of patient care and the innovation skills in the field of clinical research.
PL: Could you indicate the main cities in Italy with higher patient recruitment in clinical trials? Where are the top recruiting hospitals located?
LV: In the big metropolitan areas, such as Milan, Turin, Genoa, Rome, Bologna, Naples, Bari and Palermo you can find the biggest hospitals that can contribute very well to the recruitment of patients in clinical trials
PL: Do sponsors from other countries and continents carry out clinical trials using Italian sites? Which countries do these sponsors come from?
LV: Yes, for the reasons mentioned above many foreign sponsors decide to involve sites from Italy. Normally these sponsors are from any country in Europe but also from North America.
PL: In terms of initiation timelines, how long does it take to have a clinical trial started in Italy? What is the average time between study submission to ethics committees and regulatory authority and first patient in?
LV: The regulatory timelines for getting a trial approved in Italy from both the CA and the EC are quite similar to those of other European countries, that is, on average, about 2-3 months from first CA submission to first site initiated.
PL: Europe is known for having rigorous and demanding national regulatory authorities when it comes to evaluating clinical trial applications. For example, the quality of the drug substance and drug product manufacturing process is very important for regulators. The CMC section of the IMPD has to be very well written. What is your recommendation for biotech companies manufacturing their drugs for clinical studies to be evaluated by the Italian regulatory authority (AIFA – Agenzia Italian del Farmaco)?
LV: As you have already stated all regulatory authorities, including the Italian one (AIFA) are very rigorous in assessing the IMPD. Therefore, the only recommendation we would like to provide to biotechs is to follow the guidelines and submit all the required data.
PL: How demanding are ethics committee evaluations in Italy? What key aspects should be considered by biotech companies when preparing their clinical trial protocols and related documentation?
LV: We don’t anticipate any specific concerns from the ECs in assessing a clinical trial protocol. The most important aspect to be taken into consideration is the patient’s safety during the study that has to be carefully monitored through a risk-based monitoring and management approach and through the implementation of a DSMB if deemed appropriate for the type of study.
PL: What are the main capabilities of Exom Group and how can you help sponsors to conduct their trials in Italy?
LV: We are a full service CRO that offers all services from protocol writing and study feasibility up to final CSR, including regulatory, site monitoring, study management, data management and statistics.
PL: In which therapeutic areas is Exom Group particularly strong in terms of experience?
LV: Our main areas of experience and expertise are Oncology, Cardiovascular, Pneumology, Metabolism, Infectious diseases, and rare diseases.
PL: Does Exom Group have capabilities to manage multinational clinical trials in several European countries? For example, what is your experience with large phase 3 trials in Europe?
LV: Yes, Exom has the capability to manage multinational and multicenter clinical trials not only in Europe but also in North America and Israel. So far we have successfully completed a dozen of such large multinational Phase III studies.
PL: I have seen Exom Group has a wide range of electronic tools and web-based applications to optimize the execution and monitor the development of clinical trials. Could you tell us more about these innovative tools?
LV: Exom was founded in 2014 in Milan, Italy. Our goal from the beginning was to make the conduction of clinical trials more efficient utilizing innovative technologies and combining it with the expertise of our clinical project managers, data managers, and monitors.
To reach this goal, we began developing the Genius SUITE in 2014 after establishing our 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.
On an ongoing basis, we develop new solutions that complemented our 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 color code and gives them direct access to the appropriate item without tedious navigation through different systems.
True to our commitment to improving clinical trials for all stakeholders, we 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 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 the SAS Institute, allows early detection of signals in clinical trials, making them safer and more efficient.
In 2019, we started developing our third iteration of the electronic Informed Consent, Genius ENGAGE. It became 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 us 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.
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 HIPAA compliance and reduces the risk of potential data breaches.
PL: It seems Exom Group is at the forefront of technological innovation applied to clinical trials. Could you tell us about future disruptive technologies ⸺if any⸺ that may have a major impact on how clinical trials will be done in the years ahead?
LV: 2019 and 2020 showed us that clinical trials as we have known them for decades are outdated and very slow.
New research paradigms are needed to break down barriers between real world data and clinical research, so that evidence can be shared rapidly to improve both domains across a learning health care system. For instance, more trials can incorporate data from electronic health records, and adopt electronic informed consent, to enroll more patients in clinical trials closer to where they live and work. This can reduce barriers to clinical trial participation and accelerate researchers’ ability to ask and answer important questions.
Remote Decentralized Clinical Trials (RDCTs) are trials that make use of digital innovations and other novel methods to make them more accessible to participants. By moving clinical trial activities to the participant’s home or to other local settings this minimizes or eliminates physical visits to at clinical trial centers.
RDCTs using telemedicine and other emerging and novel information technology (IT) services offer the potential for local healthcare professionals to participate in clinical trials. This approach provides several advantages compared to traditional clinical trials conducted at more centralized clinical trial sites, including the following:
- Faster trial participant recruitment, which can accelerate trial participant access to important medical interventions and reduce costs for sponsors.
- Improved trial participant retention, which may reduce missing data, shorten clinical trial timelines, and improve data interpretability.
- Greater control, convenience, and comfort for trial participants by offering at home or local patient care.
- Increased diversity of the population enrolled in clinical trials.
- An opportunity for home administration or home use of the IMP, which may be more representative of real-world administration/use post-approval.
We consider RDCTs as the future of clinical trials, making drug and device development more efficient and close to real-life.
PL: If you had to tell your clients the top most important aspects to be considered when planning a clinical trial. What would you tell them? What are the “secrets” to clinical study success according to your experience?
LV: This is an excellent question, which at the same time is difficult to answer. Since no study is the same, there is no single recipe for the success of a study.
What is incredibly important, though, is the right planning and the selection of the right technologies, as well as their areas of application. For example, it is essential to evaluate at the beginning of the study planning to what extent a study can be shifted from a site-based approach to a virtual or decentralized approach. Mixed approaches are also possible here.
Furthermore, it is very important not to base study decisions on outdated data, but on real-time data with the help of tools like Genius Wizard. This helps to make the right decision at the right time, based on current study data, which in turn significantly improves the quality of the studies.
PL: Luigi, thanks a lot for this interesting interview. It has been great to learn more about clinical trials in Italy.
LV: Thank you very much for giving me the opportunity to talk about our innovative clinical trial management approach.
About Exom Group
Exom is a Milan, Italy based CRO, which is committed to the modernization of Clinical Trials through Digital Transformation and Patient Engagement. By combining its expertise across medical, regulatory and operational functions with its proprietary, multi-modular and cloud-based platform Genius SUITE™, Exom improves efficiencies and escalate process speeds while ensuring highest data quality and cost reductions, from Early Phase to Late Stage & No-Interventional Studies.
For further information about conducting clinical trials in Italy, please contact us at info@sofpromed.com
