How a young MedTech successfully conducted a complex, decentralized clinical study.

For Emagina, launching its first clinical investigation represented a decisive milestone, as it would determine both CE certification and market access. Led by a team of modern and committed entrepreneurs, the company never considered delegating such a strategic stage of its development.

Given the nature of the medical device, it was essential to conduct the trial under real-world conditions, as close as possible to the patients, in the privacy of their homes throughout the pregnancy. Running a hospital-based clinical study using traditional models would have meant moving away from a genuinely patient-centered approach.

Executing a decentralized study in real-life conditions required close collaboration with independent midwives, most of whom had never previously participated in a clinical trial. This reality meant navigating the complexity of the European regulatory framework (MDR) and ICH-GCP guidelines, while making every stage of the protocol clear and manageable for non-specialist healthcare professionals.

At the same time, interoperability with the Emagina app had to be both simple and intuitive to ensure a seamless user experience for patients. Throughout the study, which was managed jointly by Emagina and the midwives, patients received validated questionnaires to complete at home. This approach enabled the collection of feedback and the monitoring of health status directly in the home environment, without intermediaries.

The team first worked with a Clinical Project Manager, and then with a Clinical Research Associate (CRA). Providing fast and effective training was essential to maintain study continuity, preserve its integrity, and sustain the engagement of all professionals involved in the field.

These challenges could easily have become insurmountable without the right tools and the right partners.

To meet these challenges, Emagina chose Datacapt, attracted by the platform’s intuitive interface, its features tailored to real-life trials, and the high level of support provided by its team.

Datacapt developed a customized solution that, following automated randomization, directly sent patients their login details for the Emagina platform, without any manual intervention. This approach ensured both data anonymity and compliance with Good Clinical Practice, while greatly simplifying the logistics of the trial.

The creation of the forms, automations, and platform integrations was handled entirely by the lead project manager, who had no technical background. The CRA was then able to quickly take over the platform, bringing improvements thanks to their fresh perspective and through the new features developed by Datacapt, supported by additional input from the team.

Training midwives to use the platform and follow the protocol via the eCRF was quick and effective, and was conducted directly by the CRA and Paola Bourdon, co-founder of Emagina. There could be no better person than a product expert to guide the clinical staff through this innovative study.

Monitoring was optimized using real-time dashboards, which enabled proactive and personalized oversight, fully aligned with the reality on the ground. This approach allowed Emagina’s clinical teams to reach their enrollment targets and ensure strong overall compliance.

The configuration of the study forms was completed in just a few weeks, well ahead of the trial’s official start, eliminating any organizational barriers. Training for the midwives was fast and effective, requiring just a few minutes to get started.

The automated distribution of questionnaires significantly reduced the administrative workload of the internal teams. Thanks to an intuitive user experience and built-in reminders, the questionnaire completion rate reached 100%, without the need for additional administrative input or manual follow-ups.

Real-time tracking gave Emagina a high degree of responsiveness, enabling the team to manage the study with agility, even in the face of unexpected developments. The ease of use of Datacapt freed up valuable time and allowed the team to focus on what truly mattered: supporting patients, engaging the midwives, and elevating the value of the clinical results.

Finally, the data collected was immediately ready for analysis, reinforcing Emagina’s ability to demonstrate the quality and safety of its device, a key step in the regulatory validation process.