Horsham, Pa.; September 14 , 2022 — Today Clinical ink, a global life science company, announces the launch of its new, configurable electronic clinical outcomes assessment (eCOA) technology. Powered by outcomes science expertise across multiple therapeutic areas, new and enhanced Clinical ink eCOA technology ensures faster study deployment and superior data quality, as well as better patient engagement and compliance, across all degrees of protocol endpoint complexity.

Often time-consuming and dependent on rigorous development, traditional eCOA platforms or applications are known to take extensive time and underperform—causing patients to drop out of clinical studies, costly data reconciliation, and delayed Sponsor timelines. The industry sorely needs a smarter eCOA that can reduce patient and site burden as well as accelerate therapy validation.

Clinical ink’s enhanced eCOA technology was designed to meet these challenges. It ensures speed via a 100% configurable activity designer, coupled with easy-to-use study build tools. The designer includes a drag-and-drop interface to advance the customization of complex eCOA activities, based off an extensive eCOA library that includes translations and data mappings. Better, it allows a real-time preview, ensuring an expedited build, as well as a more accessible experience by incorporating live translation manager tools and facilitating real-time translation—all possible through a single click.

This enhanced eCOA functionality is notably available via technology empowerment, a subscription license-based model that allows Clinical ink partners to “do it themselves” by configuring site and patient-friendly eCOAs without the need for complex development or extensive back and forth. Adding to this increased functionality, the enhanced Clinical ink eCOA technology further powers patient outcomes by ensuring BYOD deployment compatibility, customized and interactive patient alerts, and secure, personalized resources via a patient portal.

“At Clinical ink, we believe that consistency, reliability, and speed are critical to a successful eCOA platform. Customers want to be assured that the technology they deploy is true to sale, trustworthy, and will meet their study timelines.” says Lane Nichols, Executive Vice President, Head of Product at Clinical ink. “By applying years of clinical research, patient science expertise, and eCOA application design, Clinical ink has built a better way to accelerate eCOAs. We are dedicated to pioneering eCOA technology—consistently delivering a faster, smarter, and more reliable solution.”

About Clinical ink

Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.

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Clinical Ink’s complex eCOA scales and assessments solutions include the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Vineland-3, Bayley-III, and others that have never been implemented effectively in an electronic format. Lunexis supports administering complex rating instruments and enables audio and video (A/V) collection that facilitate rater review to ensure inter- and intra-rater reliability.

“A significant share of the clinical trials industry is still relying on paper and pencil cognitive tests when electronic versions are available — versions that support not only better data quality but reduced timelines and cost,” said Clinical Ink CEO Ed Seguine. “Our complex eCOA scales and assessment implementations represent a new standard of trial execution simplicity and efficiency.”

A neuropsychologist with firsthand experience with Clinical Ink’s customized complex scales and assessments recently stated, “This project was a huge undertaking, and I was sure I was going to find at least a couple errors in that data generated by Clinical Ink’s eCOA. There were no errors. They eliminated the inevitable human errors that occur when using traditional solutions requiring transcription and manual grading.”

Clinical Ink implements and deploys clinician reported scales and assessments for even the most complex eCOA solutions, streamlining work flows and producing clean, complete data for challenging studies. Clinical Ink’s real-time prompts and edit checks help provide complete data sets, from which complex scoring can be generated automatically. Data can be monitored as it comes in and queried as appropriate.

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, and patients at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and provides anytime, anywhere data access, saving resources as your trials progress.

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The EMA response was requested by Novartis Europharm Limited and cites data and insights gained from numerous Phase I, II, and III studies using Clinical ink’s eSource platform to provide real-world context for the business benefits and implementation use-cases of deploying eSource DDC in global studies.

The opinion concludes that eSource DDC, when implemented correctly, is GCP-compliant and can be used in support of regulatory filings. The regulators identified several critical differences in capturing source data electronically as opposed to simply implementing a traditional EDC system. This opinion also serves to eliminate the perceived uncertainty between the FDA’s previous endorsement of eSource. 

Notable metrics cited in the Novartis business case include:

• Time to data availability dropped six-fold.
• Number of data points that remained unchanged throughout the study increased 7%, indicating fewer changes because of data queries or monitoring.
• Time to resolve data queries dropped by more than half.

This and other evidence led the EMA to state in its opinion that, “eSource DDC has the potential to improve quality of data and lead to operational efficiencies.”

Regulatory endorsements of eSource technology from organizations like the FDA and EMA make it easier for sponsors and CROs to implement the kind of innovative technology that is revolutionizing the way clinical trials are conducted. As an industry pioneer, Clinical ink is lighting the way forward.

Find out how our technology brings you an integrated, convenient eSource solution that provides anytime, anywhere access to your study data. Clinical ink’s interconnected eSource ecosystem illuminates your data and empowers you to make well-informed, confident decisions.

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