Exom is proud to announce that Peter Rottmann is awarded as one of the 10 Best CTOs of the Year 2021 by the C-Level Focus Magazine.

On this occasion, Peter Rottmann, CTO amd Co-Founder of Exom Group, Speaks to The C-Level Focus on “Enhancing Clinical Trials Digitally”.

In the Interview, Peter elaborates on the challenges of developing new technologies and Exom’s strategy on future development and integration of innovative technologies in clinical trials, to make them more efficient and enabling drugs getting market access faster. All with the goal of improving patients lives all over the world.

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“Enhancing Clinical Trials Digitally”

Exom was founded in 2014 in Milan, Italy, as a digital CRO. Their goal was to make the conduction of clinical trials more efficient utilizing innovative technologies. By combining the expertise of their clinical project managers, data managers, and monitors with advanced technologies, the aim was to shorten study timelines, improve the quality and make clinical trials more cost-effective. This transformation, moving the traditional clinical trial approach to a new innovative one, required a “digital mindset” from the entire team.

“From the beginning on, it was not only about technology. When working as a digital CRO, one must not forget about the people utilizing the solutions. This area is where “older” companies that are just getting into digitization forget to get their employees on board,” says Peter Rottmann, Chief Technology Officer & Co-Founder at Exom Group. “When developing our Genius SUITE, a multi-modular, cloud-based platform with tools to support project managers, investigators, monitors, sponsors, and patients, our top priority was to have an overall concept and never lose sight of our goal.”

One of the recipes for success was to mix proven approaches with new technologies and ensure the reusability of the individual technology building blocks wherever possible. “This strategy increased our efficiencies extraordinarily during the development and daily usage of the products,” adds Rottmann.

According to Rottmann, one of the most significant advantages of digitizing clinical trials is the availability of data in real-time, which allows for a timely analysis of the trial data. This also gives the possibility to predict potential issues (technology- or study-based) that were not on the radar from the beginning. Further – particularly interesting for early-stage studies – signals can be detected early using artificial intelligence, allowing informed go/no-go decisions at a very early stage, thus saving the sponsor many costs. Furthermore, it is possible to convert the classical site-based approach into a remote or virtual study model. In this case, study visits at study sites are supplemented or even replaced by televisits, which allows a much more flexible study model already in the design phase of the protocol. This approach also allows patients who were previously unable to participate in studies for various reasons.

“Exom Group is “The Human Digital CRO”, that provides value-added services through digital applications for clinical development of drugs & medical devices. Exom combines the strong medical, regulatory and operational expertise of his staff, with the most disruptive digital cloud and mobile solutions to reduce costs and increase quality and performance of clinical trials.”

“In addition, the digitization of clinical trials increases patient safety, as continuous monitoring of safety parameters can take place,” says Rottmann. “Last but not least, investigators and sponsors benefit from time savings and an increase in the quality and accuracy of study data.”

Exom’s goal in developing new solutions for clinical trials has always been simplicity. This mindset is reflected not lastly with the single sign-on approach, enabling investigators, sponsors, and CROs to use only one password to access all applications. “Our ultimate goal is to reduce the effort required in clinical trials, such as the additional work for investigators,” says Rottmann. “When introducing new technologies like the electronic Informed Consent Form or our telemedicine platform, it was imperative for us to have a simple user interface one can use without extensive training.” Rottmann and his team also support investigators with tools such as an interactive personal assistant that gives them an overview of their open tasks at a glance and allows them to interact directly with other modules in their suite, such as the eCRF. “The feedback from investigators in studies where we have already used this system has been consistently positive and reinforces that our direction is the right one.”

Rottmann foresees many new technologies and paradigms coming, and many companies like them are already working on solutions. He witnesses many different opportunities in eSource and clinical trials with the support of AI and ML. “We will clearly focus on improving our remote solution to increase adoption and overcome barriers related to demographics and regulations. Unfortunately, this is an issue I see a lot in the market: a nicely predicted solution that is usable only in certain geographical regions like the US,” he says. “In Europe, for example, existing solutions coming from the US market, such as eSource, remote monitoring, or electronic consent, do not always fit the requirements of the EMA or European regulations like the GPDR. They usually have different requirements on the type of digital signature used or how a health record can be processed for a clinical trial. This issue often leads to a situation where these solutions can only be used for a smaller type of clinical trials with less impact on the patient or require customization for the European market to meet the requirements of local regulations. The use of standard describing data formats like FHIR (Fast Healthcare Interoperable Resources) can accelerate the technical implementation on the other side.”


Interview from C-Level Focus Magazine https://clevelfocus.com/Peter-Rottmann-Chief-Technology-Officer-&-Co-Founder-of-Exom-Group-Awarded-CTOs-2021-by-clevelfocus.html

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