It is now much easier for clinical trial sites to manage subject data as well as randomization, inventory management and drug dispensation. These processes can now be performed in real time using the single interface and unified database of encapsia, the clinical data suite developed by the technology division of MassBio member Cmed Inc.
The breakthrough announced on June 20 was made possible by a deep “hyper integration” between encapsia with leading-edge technology platforms PULSE and DRIVE from endpoint Clinical. The integration allows the power of endpoint’s interactive response technology (IRT) to be accessed through the eSource App of encapsia, reducing site burden, the number of software systems used and operational study costs.
“With both organizations focused on simplifying the management of complex trials, particularly oncology studies, it was a natural partnership to integrate our two state-of-the-art technology systems to provide sites with a more advanced and modern-day approach to clinical trial management,” said Vincent Puglia, Senior Director, Strategic Alliances, endpoint.
The new technology offering was designed by connecting endpoint’s leading-edge technology platforms, PULSE and DRIVE, with Cmed’s new dedicated web app, Inventory, further increasing the scope of its third generation clinical data suite encapsia.
“Although clinical trial designs become more complex over time, it shouldn’t mean that they get more challenging to manage. We need to provide all sites with technology that is intuitive and easy to use. With encapsia, site users no longer have the burden of using a separate IRT system. The most complex IRT tasks handled by endpoint’s IRT platform like managing subject data as well as randomization, inventory management, and drug dispensation can now be performed in real time using the single interface and unified database of encapsia. This revolutionary advancement not only benefits sites by saving them time and burden but also time and cost savings that carry through to the entire clinical study,” said Timothy Corbett-Clark, CTO, Cmed.
Site users see immediate benefits through this advanced technology by being able to perform all the tasks of an eCRF and IRT within the single user interface of encapsia, including:
- An intuitive “barcode first” approach to process and inventory shipments quickly;
- The ability to record and validate patient data, request drug dispensation, perform drug accountability, or randomize directly from the eSource iPad app. IRTdata is automatically populated into encapsia, making the patient visit smooth and quick;
- Trial specific nuances are easily accommodated through configurable dispensation workflows;
- Inbuilt checks to ensure the right supplies are dispensed for both blinded and open-label studies;
- If the internet connection is unavailable during time-critical patient consultations, the system works offline and has the backup of a 24/7 call center to enable data capture and dispensation to proceed with minimal delay and smooth recovery;
- Emergency functions like subject treatment unblinding remain instantly accessible via endpoint IRT while being safely discrete and secure from the blinded eSource system;
- At the end of the trial, monitors ensure compliance by reconciling returns and destructions, simply and easily all within the same system.
As the complexities of clinical trials steadily increase, endpoint and Cmed are dedicated to enhance their technologies further to minimize the burden on site staff and provide them with an optimal “consumer-like” experience.