Enhancing clinical data management with our advanced eSource solution

Electronic Health Records (EHRs) and related technologies are often highlighted as promising eSource solutions for data acquisition in clinical trials. Utilizing EHRs as an eSource makes sense due to their widespread use and the rich data they contain. However, sourcing data directly from EHRs or Clinical Information Systems (CIS) is not without challenges. Issues such as the accuracy of the data contained within EHRs, interoperability between different EHR systems, and the usability and safety of these systems must be carefully considered. Additionally, the rigidity of data models, the need for custom installations in each hospital, and complex data query processes further complicate their use as eSource.

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In the industry of clinical trials, electronic Patient-Reported Outcomes (ePRO) and electronic Clinical Outcome Assessments (eCOA) instruments, along with various mobile applications ranging from certified class I/II medical device software to fitness apps, are recognized as viable eSource options. These technologies face several hurdles, including lack of standardization across organizations, regulatory uncertainties, resource constraints at sites and sponsors, cost and budget concerns, and infrastructure challenges. These issues must be addressed to fully integrate devices and apps as effective sources of data.

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Stakeholders in clinical trials often experience specific challenges when using non-CRFs as an eSource. These challenges include the delivery of expected file formats, the need for personal training, slow uptake of new technology, difficulties in adhering to timelines, and a heavy reliance on manual data mapping and batch loading processes, which lack semantic interoperability. Despite these challenges, there are notable benefits: improved protocol compliance, the inclusion of additional contextual information in raw data files that can be leveraged for further exploratory studies and protocol improvements.

This is where oomnia comes into play. It covers all facets of clinical data interoperability.
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Direct Data Capture (DDC) is traditionally understood in the context of using electronic Case Report Forms (eCRFs) as the primary tool for data entry, without the creation of source documents beforehand. This method often involves the use of special devices or tablets, which must be transported to the site and used as a data collection resource. This approach, however, is associated with several challenges, including delays in study startup, increased costs, extensive training time, logistical complexities, and demands on site infrastructure. These factors must be considered to optimize the use of DDC in clinical trials.

Our oomnia software is highly dynamic as the medicine is. We adapt to your needs and respect your workflows.
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