Clinical Ink has announced enhancements to its Lunexis ePRO+ electronic patient-reported outcome module. The module is part of the company’s unified trial technology platform, which reportedly helps streamline implementation and gives both patients and sites the ability to choose which devices they use to participate in a study: smartphone, tablet or web.
“Patients benefit when they can choose how to participate in a clinical trial – to the extent permitted by the protocol,” Ed Seguine, Clinical Ink CEO, told Outsourcing-Pharma. “It provides convenience and flexibility for them to participate while minimizing the impact on their daily lives; it is critical to good outcomes, compliance, and keeping patients enrolled for the duration of the study.”
Additionally, sponsors have the option of which deployment modalities best suit their protocols and patients, instead of having the platform drive the choice for them. According to the company, the platform permits study builds in less than 30 days, including translations.
Seguine said the McKesson Ventures investment in the technology reflects the rapidly evolving needs of the trial industry.
“A unified, flexible, patient-centric solution helps patients consistently contribute the data that sponsors need, giving confidence in the data integrity, whatever the trial design. McKesson Ventures’ investment further validates the need for, and opportunity represented by, these technologies," he commented.
The eSource ecosystem that Lunexis ePRO+ is part of is designed to simplify real-time data collection workflows, which gives study teams the ability to make critical study decisions. Sponsors reportedly benefit from higher-quality data, with a process that permits for more actively engaged patients and more efficient entry of information by sites.
TransPerfect Translations has partnered with Clinical Ink to come up with ways to revamp and simplify the translation process. Seguine told OSP the collaboration will involve real-time collaboration on the same study design platform.
“Particularly for eCOA/ePRO, the translation effort is often an afterthought and completed after the English-language study build – this causes substantial delays and is a manual email/file-based process,” he pointed out. “TransPerfect helped us refine a workflow model that allows them to interact directly with our system in real time as the forms are built; they can see the visual layout instantaneously and make adjustments themselves for different line spacing and word lengths from language to language. This simultaneous collaboration (as opposed to sequential workflow) will eliminate weeks from the typical study build process.”
The modifications in the Lunexis ePRO+ module and platform are intended to anticipate the rapidly evolving clinical research industry. Features such as mixed-modality capabilities, changes to the clinician-reported outcomes (ClinRO) feature set, and unified authoring are intended to allow for extreme flexibility and to fit with a wide array of in-person, decentralized, and hybrid clinical trials.
