Clinical trial sites save time dispensing investigational products using eSource

Written by Cmed

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 Cmed’s technology division.

The breakthrough announced today has been made possible by a deep “hyper integration” between encapsia with leading-edge technology platforms PULSE and DRIVE from endpoint Clinical. This revolutionary integration allows the power of endpoint’s interactive response technology (IRT) to be accessed through encapsia’s eSource App, reducing site burden, the number of software systems used and operational study costs.

Site users benefit immediately from this new interoperability between two clinical trial software systems 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 for quick processing and inventory of investigational product (IP) shipments;
  • 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 ensure the right supplies are dispensed for both blinded and open-label studies;
  • Even if the internet connection is unavailable during time-critical patient consultations, the system works offline and has the backup of a 247 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.

Timothy Corbett-Clark, CTO at Cmed commented “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.”

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.

Vincent Puglia, Senior Director, Strategic Alliances at endpoint commented on the collaboration “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.”

See the pdf press release here