In 2018, a traditionally structured eClinical Systems Provider found themselves at a crossroads with their technology ecosystem. To keep pace with the quickly evolving needs of the clinical research industry, they recognized the need to modernize their legacy platform and offer capabilities in line with the new options for remote data collection and study management they were starting to see. They realized they needed to fill certain gaps that existed if they were going to be able to support decentralized/virtual trials in the near future. The Provider weighed a number of options to achieve this: 1) develop their own proprietary mobile app; 2) acquire an existing solution; or 3) partner with another vendor to obtain the technology required to support data collection and study management activities remotely.
The eClinical Systems Provider needed a solution to support their clients’ growing needs for remote data collection (eConsent and ePRO/eCOA) without extensive development time. Through exhaustive research, the Provider determined they did not have the resources to invest in developing, testing, and validating their own solution. As a result, their challenge became finding an alternative solution they could get to market quickly, promote under their own brand, and offer as a downloadable iOS and Android mobile app. The Provider discovered Crucial Data Solutions’ (CDS) TrialKit mobile platform was the only solution that could meet the increasing demand for patient-centric, remote eConsent and ePRO/eCOA needs while integrating with their existing business model at a fraction of the cost. They chose TrialKit’s regulatory compliant, already-proven mobile app, particularly because it could:
- integrate directly with their legacy EDC platform
- collect data from any remote data source (study participants, wearables, remote research staff, etc.), and
- provide real-time access to data,
all of which could be done from an established platform backed by years of real-world use.
The eClinical System Provider engaged CDS to white label – or rebrand – a version of TrialKit’s iOS and Android mobile app under their own brand to seamlessly add remote eConsent and ePRO/eCOA functionality to their current ecosystem. TrialKit, which is built on web services and utilizes a RESTful API, allows for direct data integration with external systems and a seamless, two-way exchange of data. With CDS’ support, the Provider successfully configured, validated, and integrated their own version of the TrialKit app with their existing EDC platform. This approach enabled the Provider to avoid unnecessary costs to implement their own mobile solution while maintaining their brand identity.
Additionally, TrialKit’s software versioning provided the eClinical System Provider the autonomy to manage their own ecosystem and determine which new software releases to apply, and when. Regular updates continued with feature improvements and patches, without draining development resources from the Provider’s native business. CDS’ training and enablement program for new TrialKit Administrators allowed the Provider to operate under the same delivery model to which their team was already accustomed. The white label partnership also provided comprehensive support, including full access to a dedicated CDS program manager, support documentation, and Tier 2/Tier 3 support.
The white label implementation of CDS’ downloadable mobile app, TrialKit, made it possible for a traditional EDC vendor to efficiently and rapidly deploy a mobile eConsent and ePRO/eCOA solution to support the remote patient data collection needs of their current and future clients. This new mobile app offering propelled the eClinical System Provider into the expanding decentralized/virtual trial market at a much faster rate using significantly fewer resources than what would have otherwise been required.