Evinova has partnered with Lothar Medical to modernise respiratory clinical trials worldwide. The strategic partnership combines digital clinical trial technology with advanced respiratory diagnostics. Under the agreement, Evinova’s Unified Trial Solution will integrate with Lothar Medical’s respiratory devices. As a result, sponsors, clinical sites, and patients can access a more connected trial experience.
Evinova is a global leader in AI-native clinical development technology. Its Unified Trial Solution offers a GxP validated digital platform for clinical research, scaled globally. The platform supports traditional, hybrid, and decentralized clinical trials (DCTs). Today we have over 4000 sites in 54 countries using the solution. Lothar Medical is developing medical devices for respiratory diagnostics. It has technology that combines three respiratory measurements into one device. The measurements are FeNO, spirometry and oscillometry. This combined approach enables real-time pulmonary function testing across research and care settings.
“Partnering with Evinova marks an important milestone for Lothar Medical and our commitment to advancing respiratory healthcare. By combining our innovative respiratory diagnostic capabilities with Evinova’s digital clinical trial expertise, we can make clinical research more efficient, patient-focused and data-driven. Together, we have an opportunity to accelerate the development of personalised respiratory care and ultimately improve outcomes for patients,” said David Markus Thomas, Managing Director of Lothar Medical.
Supporting More Efficient Respiratory Research
The collaboration provides several benefits for teams with complex respiratory clinical development programs. Conditions that may be covered by these programs include asthma, COPD, bronchiectasis and interstitial lung disease (ILD). Respiratory diseases continue to be one of the leading causes of death worldwide. But these conditions are often diagnosed later in the patient journey by health care providers. Therefore, recruitment in clinical trials may be hampered when diagnosis does not meet study entry criteria. Emerging therapies have a growing focus on early detection and treatment.
A single device combining spirometry, oscillometry and FeNO could help address this challenge. The combined measurements can be used by clinical teams to support screening and/or diagnosis. This could help researchers to find suitable participants more efficiently. This approach could also help clinical development teams to improve recruitment processes as well. The partnership also includes a focus on endpoint and diagnostic data capture. Lothar Medical adds respiratory diagnostics expertise to the combined solution.
Evinova, in contrast, is the digital infrastructure that drives the operations of clinical trials. The companies are looking to collaborate to secure the continued provision of high-quality clinical data. The platform supports both primary and secondary endpoints in studies of respiratory diseases. These endpoints may include FEV1, PEF, FeNO, and symptom diaries. The combined approach may also be used by researchers to capture exploratory endpoints. These include measures of large and small airway resistance and reactance. Importantly, the integrated model can help to break down data silos. Clinical teams can manage respiratory measurements in a more connected trial environment.
Reducing Operational Complexity for Sites and Patients
It also addresses operational challenges throughout respiratory clinical research. A three-in-one respiratory device can help decrease the need for multiple devices. That means clinical sites may have fewer equipment and workflow issues to deal with. Trial experience is also more straightforward for patients. Also, the device interface has advanced digital coaching capabilities. Automated validation checks allow proper device use in clinical studies. These capacities may aid researchers in enhancing the consistency of the data collected. They may also help reduce potential problems with improper use of devices.
Evinova also highlighted the partnership’s potential to advance digital clinical development. The company sees respiratory diagnostics and digital trial technology as complementary capabilities.
“We are thrilled to collaborate with Lothar Medical to bring the next era of digital clinical development,” said Cristina Duran, President of Evinova. “The partnership between Lothar Medical and Evinova represents an exciting step forward for respiratory clinical research. By combining innovative respiratory diagnostics with cutting-edge digital trial capabilities, we have the opportunity to redefine how respiratory studies are delivered and accelerate the development of more personalised care for patients,” said Tim Harrison, CMO of Evinova.
The partnership positions both companies to enable more connected research in the respiratory space. It also points to the growing importance of digital technologies in today’s clinical development. Evinova and Lothar Medical combine respiratory diagnostics and digital trial infrastructure to make research more efficient. And at the same time, the companies want to shift to a more patient-centric approach to respiratory studies.
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News Source: Businesswire.com
