DTRA Archives - Clinical ink Mon, 09 Dec 2024 16:12:42 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://www.clinicalink.com/wp-content/uploads/2022/03/cropped-Clinical-Ink-Icon-Logo-32x32.png DTRA Archives - Clinical ink 32 32 Clinical ink CBO Jonathan Andrus Selected as DTRA Co-Leader Chosen to Head Decentralized Trials & Research Alliance Regulatory Gap Initiative https://www.clinicalink.com/clinical-ink-cbo-jonathan-andrus-selected-as-dtra-co-leader-chosen-to-head-decentralized-trials-research-alliance-regulatory-gap-initiative/ Thu, 12 Aug 2021 12:00:00 +0000 https://www.clinicalink.com/uncategorized/clinical-ink-cbo-jonathan-andrus-selected-as-dtra-co-leader-chosen-to-head-decentralized-trials-research-alliance-regulatory-gap-initiative/ Clinical ink CBO Jonathan Andrus Selected as DTRA Co-Leader Chosen to Head Decentralized Trials & Research Alliance Regulatory Gap Initiative Horsham, Pa.; August 12, 2021 […]

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Clinical ink CBO Jonathan Andrus Selected as DTRA Co-Leader Chosen to Head Decentralized Trials & Research Alliance Regulatory Gap Initiative

Horsham, Pa.; August 12, 2021 – Clinical ink, a global clinical trial technology company, today announced that CBO Jonathan Andrus has been selected to co-lead the Decentralized Trials & Research Alliance’s (DTRA) Initiative 4B: Collaborate on Regulatory Gaps. Building on his extensive relationships with the EMA, FDA, MHRA, and other agencies in driving industry collaboration, Andrus will lead this component of a Priority Initiative — one of four — that the DTRA has established to guide industry leadership and growth:

  • Definitions: come up with common terminology/descriptions of various aspects of decentralized trials
  • Best Practices: focus on implementation
  • Education: patient, site, and sponsor content to help make the benefits clear
  • Removing Barriers: identify and remove barriers to decentralized research implementation, establishing road maps to their resolution

Along with co-leader Chantal Le Floch, Andrus will draw on his extensive decentralized trial (DCT) experience as he facilitates and co-creates workshops while organizing the initiative team and executing all related activities. Selected from 220 individual nominees, Andrus’ selection affirms Clinical ink’s leadership position as the premier provider of DCT solutions for clinical trials.

“I’m humbled to have been chosen to further such an important initiative,” said Andrus. “We have an opportunity to craft a regulatory blueprint and establish a DCT regulatory framework that will benefit patients for years to come. I am honored to contribute to the evolutionary framework of both DCT technology and the clinical trials industry as a whole.”

The DTRA was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused DCTs and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods.

About Clinical ink
Clinical ink, a global clinical technology company, offers data certainty from source to submission via our Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO+, and eConsent modules. This suite of solutions for capturing and integrating electronic data from sites, clinicians, patients, and caregivers at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and associated delays, and provides anytime, anywhere data access, saving resources as your trials progress.

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]]> McKesson Ventures Invests as Clinical ink Debuts Lunexis ePRO+ Solution Mixed Modalities Allow Users to Switch Between Smartphones, Tablets, and Web Any Time https://www.clinicalink.com/mckesson-ventures-invests-as-clinical-ink-debuts-lunexis-epro-solution-mixed-modalities-allow-users-to-switch-between-smartphones-tablets-and-web-any-time/ Wed, 02 Dec 2020 21:15:23 +0000 https://www.clinicalink.com/uncategorized/mckesson-ventures-invests-as-clinical-ink-debuts-lunexis-epro-solution-mixed-modalities-allow-users-to-switch-between-smartphones-tablets-and-web-any-time/ HORSHAM, Pa.; Dec. 3, 2020 – Clinical ink, a global clinical trial technology company, today announced an investment from McKesson Ventures alongside its significantly enhanced electronic patient reported outcome (ePRO) module. Lunexis™ ePRO+ is part of a unified […]

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]]> HORSHAM, Pa.; Dec. 3, 2020 – Clinical ink, a global clinical trial technology company, today announced an investment from McKesson Ventures alongside its significantly enhanced electronic patient reported outcome (ePRO) module. Lunexis™ ePRO+ is part of a unified technology platform that streamlines implementation processes and allows patients and sites to choose how they want to participate in the study — smartphone, tablet, or web.  Lunexis ePRO+ allows sites and patients to have unprecedented flexibility to choose the technology option that makes the most sense for them. 

“McKesson Ventures is excited to invest in Clinical ink, a market leader in clinical trial enablement technology. Clinical ink’s innovative eSource solutions are particularly well-positioned as the industry shifts to more decentralized trials and remote monitoring,” said Dave Schulte, senior vice president and managing director of McKesson Ventures. 

Clinical trial sponsors can now choose deployment modalities to suit their protocols and patients, rather than having technology drive the selection. Despite the higher complexity this flexibility might suggest, ePRO+ still supports the rapid system implementation Clinical ink is known for, with study builds now less than 30 days, including translations. 

“As the eSource pioneers with tens of thousands of site-user interactions behind us, we know our solutions must be adaptable to patients’ and sites’ day-to-day realities,” said Clinical ink CEO Ed Seguine. “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.” 

Lunexis ePRO+ is part of an eSource ecosystem that simplifies sponsors’ and CROs’ real-time data collection workflows, enabling study teams to confidently make critical study decisions. Sponsors stand to gain higher quality data as more actively engaged patients and sites enter information more efficiently according to protocol. 

Lunexis ePRO+ does more than just simplify data collection; TransPerfect Translations has partnered with Clinical ink to completely reimagine and simplify the complex translation process. “The novel way translations are handled in Lunexis ePRO+ alleviates inefficiencies in the feedback process and condenses the typical ePRO translation workflow and timeline, which can be considerable,” said Alexandra Crane, senior director, global head of COA solutions & implementation at TransPerfect. 

These advancements for streamlining and optimizing operational execution anticipate the rapidly changing needs of the clinical research industry. Mixed-modality capabilities, associated changes to the clinician-reported outcomes (ClinRO) feature set, and time-saving, unified authoring allow for extreme flexibility and are ideal for a wide variety of physical, virtual, and hybrid clinical trials. By harnessing this vision and years of experience, this launch builds even more momentum and positions Clinical ink to continue in its role as industry leader well into the future. 

Learn more about Clinical ink’s Lunexis ePRO+: Visit clinicalink.com/technology/ecoa/. 

About Clinical ink
Clinical ink, a global clinical technology company, offers data certainty from source to submission. Our Lunexis™ eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress. Visit clinicalink.com. 

About McKesson Ventures
McKesson Ventures is a strategic venture firm backed by McKesson Corporation focusing on early and growth stage health technology and healthcare services companies. McKesson Ventures targets companies that both catalyze and benefit from the key changes taking place in the U.S. healthcare landscape. McKesson Corporation is a healthcare services and information solutions company dedicated to making the business of healthcare run better. Visit www.mckessonventures.com to learn more. 

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