From device to database in 2 weeks made possible by Wemedoo and Withings

Clinical trials in metabolic, cardiovascular, and weight-loss therapies depend on accurate, continuous, and patient-friendly monitoring. But achieving this balance, precision without burden, is not easy.

By combining Wemedoo’s oomnia system with Withings’ medically validated connected devices, sponsors can now collect real-time patient data directly from the home. The result: seamless data capture, full regulatory compliance, and complete study oversight, without extra work for patients or sites.

Challenge

Integrating medical devices into clinical trials sounds simple but quickly becomes complex. Sponsors face several hurdles:

• Ensuring secure, reliable data transmission
• Standardizing diverse measurement units
• Meeting regulatory requirements (21 CFR Part 11, GDPR, HIPAA)
• Capturing patient data streams directly into clinical databases without errors

Without the right system, this often results in manual data entry, high monitoring costs, and delays.

Solution

oomnia changed this complex process into a smooth, automated workflow.

• At home: Patients used Withings smart scales
• In the background: Measurements were synced through the Withings app and were collected on a dedicated virtual machine built for the study
• In oomnia, data was automatically mapped into each patient’s EDC document, complete with timestamps and status

Key capabilities included:

• Grouping of measurements (weight, visceral fat, PWV, etc.) for structured tracking
• Repetitive groups in eCOA documents to capture longitudinal data
• Automatically calculated fields, such as MI are generated natively in oomnia

All data entered the system audit-ready, secure, and without manual input from site staff or patients.

“Integrating a medically validated device like the Withings scale into oomnia proved the strength of our system. We delivered a fully compliant, real-time data flow in record time, making life easier for both sponsors and study teams.” –Caslav Vojvodic, Head Integration, Wemedoo

Results

The integration was executed efficiently, with every requirement successfully met.

• Secure protocols, validation of scale data, and unit standardization were implemented efficiently
• The full integration was completed in just 2 weeks, significantly faster than the typical 3–6 weeks outlined in the Withings integration project plan
• The study ran without delays and produced validated, complete datasets
• Sponsors gained real-time access to patient data without technical obstacles

This case proves that oomnia can integrate even the most advanced medical devices, delivering fast, compliant, and sponsor-ready solutions that simplify trials for everyone involved.

“This project highlighted how oomnia combines domain expertise with technology. By resolving regulatory and scientific complexities quickly, we showed sponsors that advanced device integrations can be done seamlessly and without delays.” – Nikola Cihoric, Founder and Chief Product Officer, Wemedoo

About the trial

The project centered on using Withings scales to capture continuous patient data in a decentralized clinical study. Patients performed measurements at home, generating data on body weight, body composition, vascular age, and other critical health parameters.

The trial required a secure, regulatorily compliant integration that ensured every measurement was validated, captured automatically, and aligned with the study protocol. oomnia enabled this without burdening patients or clinical staff.

Project outcome

By leveraging oomnia’s unified system and Withings’ connected devices, the sponsor achieved audit-ready data capture in real time. Manual entry and reconciliation were eliminated, setup was completed in a short timeframe, and the study team had full oversight throughout.

The outcome demonstrated that device-based data collection, long seen as technically risky and time-consuming, can now be delivered out-of-the-box with speed, compliance, and patient-centric simplicity.

About Withings Health Solutions

Withings Health Solutions is a leader in connected health. With more than a decade of expertise and millions of users of their solutions, they excel at taking the complication out of running a digital health program. Their portfolio of solutions, from connected devices such as blood pressure monitors and smart temporal thermometers to scales, are beautifully designed and easy to use while providing medical-grade insights from home. They help both care teams and patients to achieve higher quality care.

“This partnership with Wemedoo showed how quickly advanced device integrations can become a reality. In just two weeks, sponsors had access to continuous patient-generated measures like weight, body composition, and vascular age, all captured effortlessly from home. It’s proof that when technology is simple for patients, engagement goes up and trials run smoother for everyone involved.” – Antoine Pivron, VP, Withings Health Solutions.

Fore more information visit: https://withingshealthsolutions.com/

About Wemedoo

Wemedoo is the creator of oomnia, a unified clinical research platform that integrates EDC, eCOA, ePRO, CTMS, eConsent,eSource, RTSM, and eTMF. With out-of-the-box API integrations like Withings connectivity, oomnia enables sponsors to run complex decentralized and hybrid trials faster, more securely, and with a better patient experience, all in full compliance with global regulatory standard.