The dramatic coronavirus (COVID-19) pandemic in recent months has disrupted clinical trials along with all aspects of daily life. Medical staff are being redeployed within health organizations to support the care of those infected. Travel bans and access restrictions to medical facilities means sponsors need ways to continue current studies to bring new therapies to market and support patients.
The unique architecture of encapsia provides a flexible way to support virtualized clinical trials including monitoring:
- Home visits: encapsia lets you conduct a trial visit at a patient’s home, avoiding the need for patients to travel to site
- eSource: encapsia Direct Data Capture (DDC) is an easy to use app designed for any iPad and is easily accessible from the App Store anywhere in the world
- Smooth patient interaction: Sites can request drug dispensation, perform drug accountability, or randomize directly from the eSource or Home Visit apps. As IRT data is automatically pushed to encapsia in real time, patient contact time is smooth and quick.
- Less monitoring: With DDC there is no transcription of the clinical data, so no need for source data verification (SDV), reducing site visits by trial monitors
- Data quality: Complex validation checks run immediately on data entry to ensure clean data from the start
- Adaptability and easy adoption: encapsia supports both EDC and eSource DDC within the same study, allowing clinical teams the flexibility to manage site preferences or capabilities as needed
- Inbuilt visualizations of clinical data and metadata support monitoring and oversight of study progress, enabling all stakeholders to make faster decisions
- Third party data, for example from laboratories or wearables, can be uploaded by the user or by automated transfer rules with minimal intervention
- Database availability: encapsia is available 24 x 7 for the entire study team with no end user downtime for mid-study design changes or maintenance.
- Straightforward integration with other systems to support simplified site workflows e.g. eCOA, ePRO, patient randomization or legacy EDC.
The coronavirus pandemic is forcing a change of approach in study planning and accelerating the adoption of new technologies, with increased use of decentralized trials. The unique architecture of encapsia provides the real-time data access and flexibility to support virtualized clinical trials.