Horsham, PA – Clinical ink, a global life science technology company, has developed a self-testing app to measure cognitive impairment in patients diagnosed with COVID-19 compared to those without COVID-19. The app is currently deployed in a study of the risk factors, symptoms, disease course, and clinical outcomes of COVID-19 among members of the US military population.

The Uniformed Service University (USU) Infectious Disease Clinical Research Program (IDCRP) is conducting the “Epidemiology, Immunity, and Clinical Characteristics of Emerging Infections Diseases with Pandemic Potential,” or EPICC Study to further the IDCRP mission of reducing the impact of infectious disease in the military population. Study results have and will be further shared with Military Health System leaders and others with the goal of informing clinical care and practice guidelines for managing patients with COVID-19. IDCRP is supported by The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).

As neurocognitive complications, e.g. ‘brain fog,’ have frequently been reported with COVID-19 and present a significant concern for active duty personnel and others, IDCRP researchers sought a way to evaluate the presence, severity, and domains of cognitive impairment among study subjects. Clinical ink’s mobile app, which is built on the BrainBaseline platform—a scientifically validated research solution—is designed to do that using measures that digitally replicate those used in large, in-clinic cohort studies.

“Because the self-testing platform works on participant’s electronic devices—their personal smartphones as well as tablets—and is easy to use, it collects cognitive data remotely, without the need for specially-trained testers,” said Joan Severson, Chief Innovation Officer at Clinical ink.

The mobile assessments require no more than 20 minutes of the participant’s time, and are specifically designed to test the user’s memory, attention, cognitive flexibility, visual short-term memory, and processing speed. Designed by Clinical ink’s internal engineering, clinical, and user experience (UX) experts, the app also includes embedded information about the study and easy-to-understand instructions for completing the assessments. It is currently available for download within the Apple App Store only for study participants

“HJF appreciates how enabling technology can improve research processes, efficiency, and outcomes,” said Dr. Joseph Caravalho, President and Chief Executive Officer of HJF. “Deploying such technology in clinical trials with this select study population has the added long-term benefit of identifying best practices for its use in the general population.”

Of the approximately 7,500 participants currently enrolled in the EPICC study, up to 1,000 will be asked to complete the mobile, cognitive self-assessment as part of a sub-study module at a single cross-sectional timepoint, and again in 6 months for those that are still active in the study at that time.

“We’re delighted to possess the advanced capabilities to furnish USU with a tool to complete this invaluable research,” continued Ed Seguine, Chief Executive Officer at Clinical ink. “The need to better understand the long-term effects of COVID-19 on cognition is one of the most pressing research needs of our current time. We’re proud to be adding to the scientific record in this important area.”

More information about the study can be found here.

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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Horsham, Pa.; August 11, 2022 — Clinical ink, a global life science technology company, has partnered with the research team at the NeuroMetrology Lab, part of the Nuffield Department of Clinical Neurosciences at the University of Oxford, to deploy remote technology that captures study participants’ symptoms at home. The QxQUIP Study (Oxford Quantification in Parkinsonism) follows patients over the course of two years and aims to identify measures that can detect Parkinson’s disease progression before the onset of significant symptoms.

This research was initially carried out via in-person clinic visits—conducted four times annually—but with the advent of the pandemic, these visits temporarily halted. A new Sponsor grant enabled the NeuroMetrology Group to include remote or at-home data collection in the study, and work with Clinical ink. By deploying Clinical ink’s sophisticated, sensor and wearable technology and BrainBaseline platform, researchers are now able to gather additional data and insight into Parkinson’s disease progression.

“The Covid pandemic was a dark period for many, and yet it accelerated this change in the way this research project is being carried out. The team is now able to gather richer, more nuanced, and accurate data to feed into their analysis.” says Professor Chrystalina Antoniades of the Nuffield Department of Clinical Neurosciences, Head of the NeuroMetrology Group. “The outcomes of this project will improve diagnosis, tracking and treatment of Parkinson’s… [making] clinical trials more efficient, leading to faster drug discovery not only for Parkinson’s, but potentially for a range of neurological conditions.”

Participants in the study are already reporting high satisfaction with the study and the mobile technology, citing that the wearables are “easy to use,” the instructions “clear,” and the exercises “well explained and not at all difficult to accomplish.” This feedback further proves Clinical ink’s commitment to engineering sophisticated, built-for-purpose sensor technology that also offers the best possible user experience. 

Joan Severson, Chief Innovation Officer at Clinical ink, said: “We are honored that our mobile and wearable technology plays an integral role in this study of Parkinson’s disease at Oxford. More, we are excited to collaborate with researchers who tirelessly work to increase objective numerical measures for diagnosing and monitoring disease progression.”

This work follows Clinical ink’s groundbreaking initial findings in the WATCH-PD study, part of the Critical Path Institute’s 3DT and Parkinson’s initiatives, which provides preliminary support for the generation of digital biomarkers associated with Parkinson’s status. 

More information about the Nuffield Department of Clinical Neurosciences at the University of Oxford partnership and the QxQUIP Study can be found here.

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.  

About the Nuffield Department of Clinical Neurosciences, University of Oxford   

The Nuffield Department of Clinical Neurosciences (NDCN) aims to carry out high quality research into the function of the nervous system in health and disease. NDCN builds on a long history of research in neurology, brain imaging, eye disorders, and anaesthetics in Oxford which has made major contributions to our understanding of how the brain works and to the development of treatments which have changed lives. 

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Cutting-edge research reveals greater insights into Parkinson’s Disease progression. 85% accuracy in early Parkinson’s classification establishes Clinical ink as the industry leader in patient science and digital biomarkers.

Horsham, PA, April 4, 2022 — Clinical ink, a global life science technology company, today announces research that strengthens its standing as a critical partner in advancing clinical development for Parkinson’s disease. The WATCH-PD study findings demonstrate the promise of patient-driven mobile assessments and data collection for developing digital biomarkers, showing that these yield greater insights into Parkinson’s disease progression.

Parkinson’s disease is notoriously difficult to quantify, but analysis revealed 85% accuracy in early Parkinson’s classification. The WATCH-PD study deployed in-clinic and at-home wearable assessments. Parkinson’s patients and healthy volunteers completed active assessments via mobile iPhone and corresponding Apple Watch applications designed and developed by Clinical ink. Unique to the Clinical ink solution is the combination of patients’ active and continuous passive data collection, which was processed, monitored, and analyzed on Clinical ink’s BrainBaseline platform.

“For over a decade, we have pioneered novel approaches to collecting and connecting patient data,” said Clinical ink Chief Executive Officer Ed Seguine. “Findings from the WATCH-PD study demonstrate that patient-driven technology and patient science will play an integral role in clinical discovery.”

The WATCH-PD study is part of the Critical Path Institute’s 3DT and Parkinson’s initiatives and provides preliminary support for the generation of digital biomarkers associated with Parkinson’s status. Critically, this work demonstrates that more extensive remotely-monitored measures—gathered via mobile technology and wearables—hold the potential to yield greater insights into Parkinson’s disease progression.

Clinical ink Chief Innovation Officer Joan Severson maintains, “These findings demonstrate that the sensitivity and frequency of our measurements provide richer data and greater insights. At the same time, our technology allows us to recruit and engage patients remotely, from anywhere, ensuring better participation and outcomes.”

April is Parkinson’s Awareness Month, a critical time for this announcement, as Clinical ink begins to publish this groundbreaking, collaborative work. Learn more about how we are pioneering patient science via the design and development of fit-for-purpose mobile technologies that integrate into the everyday life of Parkinson’s patients.
 

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.

The post Cutting-edge research reveals greater insights into Parkinson’s Disease progression appeared first on Clinical ink.

Horsham, Pa.; February 16, 2022 — Clinical ink, a global clinical technology company, is excited to announce our Chief Innovation Officer Joan Severson\’s collaboration on the recently published JAMA Psychiatry paper Driving Performance and Cannabis Users’ Perception of Safety: A Randomized Clinical Trial. Severson was part of the team led by Dr. Thomas Marcotte, Professor and Co-Director of the Center for Medicinal Cannabis Research, at the University of California San Diego. 

As the legalization of cannabis expands in the U.S., it is increasingly pressing to effectively measure its effects on users’ health, behavior and community. While breathalyzer tests exist to measure alcohol consumption and the ability to safely drive, no equivalent testing has been developed for cannabis use. In this trial, the team deployed proprietary, digitized assessments from Clinical Ink’s BrainBaseline platform to help measure cannabis-related impairment while driving.  

By deploying our BrainBaseline assessments with other clinical tests (e.g., blood and urine draws) as well as linking changes in driving simulator performance to the standard field sobriety test, the trial found that cannabis use resulted in “driving decrements,\” or a worsened composite driving score (CDS) for as much as 4 hours post-use—even though many participants self-reported feeling safe to drive much sooner.

Importantly, researchers were not able to correlate users’ driving decrements with the amount of cannabis ingested or THC blood concentration. As a result, the study underscores the need for methods like digital cognitive measurements to effectively assess behavior or impairment due to cannabis use, including in-field testing. 

These findings are the catalyst for expanded cannabis use measures and impact—whether negative or positive. The National Football League (NFL) recently announced $1 million in funding to the same University of California San Diego team for a clinical trial that will leverage our mobile assessments to study the effects of cannabinoids on sports-related injuries, pain management, and recovery.

“This study in JAMA, as well as the NFL award, further validates Clinical Ink’s BrainBaseline assessments as multifunctional tools to better measure patients in pressing real-world, real-time contexts,” said Severson. “It also proves the escalating need for advanced technology like ours to aid in expanding clinical discovery.”

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.

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Clinical ink’s platform uniquely supports the needs of sponsors working on Alzheimer’s trials by:

• Using direct collection tools that allow for flexible data collection options (site-based, home-based, and remote), which are critical for studies that involve contraindicated patient populations.
• Providing an integrated review of patient data progression, allowing for subtle changes in patient status can be monitored in real time.
• Including cognitive batteries, coupled with clinical outcome assessments, all on one device — enabling quality and speed.
• Delivering data to clinical research professionals in near real time, enabling timely actions in support of patients and early insights into the study data.
• Supporting at-home collection for patients via provisioned devices or bring your own device (BYOD) — the use of a patient’s own smartphone — for improved compliance and better patient experiences.
• Providing expert caregiver support for at-home patient diary solutions, which feature easy-to-follow workflows and simplified implementation.

Clinical ink’s work with the Alzheimer’s Clinical Trials Consortium (ACTC) has added to the company’s expertise, above and beyond its wealth of real-world protocol experience. Clinical ink’s proactive engagement of the multiple stakeholders it takes to build a superior tool that supports the complexities of Alzheimer’s trial conduct and data collection — including the ACTC and real-world patients — has resulted in technology that is as easy to use as it is robust.

Clinical ink CEO Ed Seguine, previously a founding manager of the Eli Lilly & Co. venture capital funds, e.Lilly, and Lilly Bioventures, said, “Alzheimer’s is an especially complicated and challenging therapeutic area in which to conduct a clinical trial. Clinical ink’s Lunexis eSource platform is custom-tailored for exactly such indications, enabling virtual and hybrid models driven by direct data capture. We’ve been pleased to work on therapies and devices offering such promise.”

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.

The post Clinical ink Adds 16th Concurrent Alzheimer’s Study Supporting 9,000+ Patients Across 25 Countries appeared first on Clinical ink.

“When you want to receive and analyze data quickly, being able to condense build times to meet urgent deadlines makes all the difference,” said Clinical Ink CEO Ed Seguine. “Furthermore, our eSource platform allows overtaxed caregivers to streamline data entry. Data is visible for remote monitoring in real time — of particular importance when sites are inaccessible and a vital consideration for this disease condition, which can change rapidly and dramatically.”

The flexibility of the Lunexis technology platform and its ability to be adapted and deployed quickly have minimized the timeline for this 300-patient, 36-site study. “Clinical Ink’s data handling makes investigative teams’ processes very efficient,” said Chief Business Officer Jonathan Andrus. “They enter data only once and stay focused on treating patients. And for sponsors, having validated data immediately available for real-time decision making is reassuring, especially in a study of critically ill patients.”

The drug under investigation is a novel intravenous anti-inflammatory. This new molecular entity is a granulocyte macrophage colony stimulating factor antagonist that already has Phase I safety data from a clinical trial in volunteers and patients with ankylosing spondylitis.

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.

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