Digital health technologies (DHTs) and digital biomarkers are transforming clinical research. Digital biomarkers are objective, measurable physiological or behavioral data collected using digital technologies such as wearables, sensors, connected drug delivery devices and mobile applications. These enable the continuous collection of patient-relevant data outside the clinic and create new opportunities for decentralized and hybrid studies.
Regulatory authorities such as the FDA and EMA are increasingly promoting the use of digital technologies in clinical trials. At the same time, the requirements for data quality, traceability, validation and study monitoring are increasing. It is becoming increasingly important for sponsors to reliably integrate digital data sources into their development programs and generate regulatory robust evidence.
BAYOOMED supports pharmaceutical companies, CROs and MedTech manufacturers in the development, integration and successful use of DHTs in clinical trials.
Our services
We accompany you along the entire path – from development to regulatory evidence:
We develop digital health technologies in accordance with regulatory requirements for use in clinical trials – from the initial idea through technical implementation to validation and documentation.
Our scope of services includes requirements management, risk assessment, technical verification and validation as well as the preparation of the necessary regulatory documentation. In this way, we create the basis for the compliant use of DHTs in clinical development programs and the acceptance of the collected data by the FDA and EMA.
We support the development and integration of digital biomarkers and endpoints to gain new clinical insights from continuously collected patient data.
Through our partnerships with providers of connected drug delivery devices, wearables and medical sensor technology, we not only provide quick access to proven technologies, but also support in selecting the most suitable DHT solution for the respective study.
We integrate DHTs into decentralized and hybrid studies and ensure the secure collection, transmission and analysis of the data collected.
We support our clients in the implementation of current FDA and EMA requirements for the use of digital technologies in clinical trials.
From technology to reliable evidence
The success of digital studies does not depend solely on the technology used. The ability to reliably collect, merge and evaluate data is crucial.
This is why we integrate DHTs directly into our MedicalOne Connect digital clinical trial platform on request. The platform connects patients, study centers, wearables, connected drug delivery devices and sponsor teams in a central infrastructure.
Features such as patient adherence monitoring, ePRO capture, real-time dashboards and centralized study data management create transparency throughout the entire study process. Sponsor teams gain early insights into data quality, adherence and study progress and can identify and address risks more quickly.
This results in high-quality, traceable and regulatory usable data for modern clinical studies.
