1. How is encapsia™ different from similar technologies in the market?
encapsia™ is a new generation clinical data suite. It has already been proven and used to successfully complete studies. It is not just hosted in the cloud, but designed to be there. As the first App based suite available, those involved in running clinical trials can now change the way they capture, monitor and manage their data. For example, encapsia™ provides direct data capture (eSource) via a mobile app, and web EDC by another app, allowing Sponsors and sites a choice, even within the same trial.
encapsia™ builds trials more quickly, improves the quality of data, and enables better decisions to be made faster because of the live data analytics and insights, all actionable within the system.
Today’s previous generation EDC and CDMS systems were never designed for today’s data demands. encapsia™ has been purposefully designed, with an architecture which will last many years and an app model that allows continuous updating, enhancing, customizing, replacement and additions as the future unfolds. It’s ultra-modern, cloud, mobile and HTML5 app based architecture is massively scalable. The fully expressed REST API and supporting advanced architecture makes it easy to provide powerful functionality and integrate with our eClinical systems. encapsia™ already has a number of powerful apps including providing full data management, fast and self-service third party data loading functionality, and medical coding. It also allows for future expansion such as electronic Informed Consent, ePRO, Patient Engagement apps etc.
2. How does encapsia™ work?
It offers a single representation of the data which all of the modules access, thus removing the pain and delays of transporting of data from one system to another. A single configuration represents each trial, defining the data structures, visit schedule, forms, validation checks and workflow for all components. In addition, various monitoring strategies (e.g. Risk-based, remote source review, eSource) can be applied to the same trial while meeting regulatory requirements.
As an App based suite, encapsia™ enables all those who either capture, review or manage data to work on the same data point in real time, as the data only exists in one place due to the centralized data structure of the system. This therefore negates the need to move data from one system to another, as with other solutions.
encapsia™ has no concept of a static schedule, with new data structures created dynamically using triggers. So simple trial configurations remain easy, without compromising ability to efficiently support the increasingly common complex trial configurations. This gives tremendous flexibility compared to current solutions in managing adaptive trial decisions, precision medicine studies, changing designs etc.
3. How does being a "technology-led" CRO enable Cmed to better serve its clients?
Not only has Cmed been designing and developing eClinical systems for over 16 years, we also know that technology alone won’t deliver. As a technology-led CRO, we have considerable expertise and experience in conducting clinical trials, we understand them and their changing, challenging nature and the operational environment. We combine our advanced technology with friendly, experienced operational people and carefully designed processes to provide our clients with a host of benefits, from lower costs to reduced timelines, and data quality and access they have previously only been able to imagine.