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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Advances in the treatment of systemic lupus erythematosus (SLE), the most common type of lupus, have been few and far between. However, with the introduction of two new therapies in 2021, that appears to be changing. Approximately 70 trials for new treatments are currently either underway or starting up. 

Even so, advanced lupus research remains a challenge for several reasons: 

• The systemic and unpredictable nature of SLE means that the assessments are highly complex, and the documentation required is extensive.
• The variability of the data increases the complexity of data input into an Electronic Data Capture (EDC) system, with a high volume of data queries involved.
• Traditionally, there has been a significant time lag between the patient visit and the data review. This is often because there isn’t enough documentation to support scoring and grading.
• Competition for patients in clinical trials provides a more significant challenge when conducting trials.

Given these difficulties, several life sciences companies and contract research organizations (CROs) asked us if our Direct Data Capture technology could be used to improve the assessments and data collection in SLE trials.   

Introducing a better way

In answer to this challenge, we created the electronic Lupus Assessment Suite® (eLAS). eLAS® is a data capture tool that allows clinicians to complete a focused physical exam in the presence of the patient. During the exam, clinicians will be able to check off SLE symptoms on electronic versions of the required assessments, grade and score the findings, and upload the data directly from their tablet to the sponsor’s dataset. The tool guides the investigator through the documentation in a logical order, auto-populates repeated fields, presents data from previous visits for comparison, and employs edit checks to prevent errors and omissions. It also highlights any patient safety concerns that the data may indicate. eLAS® supports collecting patient-reported outcomes (PROs) during the patient visit. 

Overall, eLAS® is designed to provide straightforward, efficient, and reliable Direct Data Capture (DDC). It also eliminates manual errors associated with traditional paper methods.

Immediate data collection, edits, and reviews

This streamlined approach to collecting data can produce a marked improvement in data quality, patient safety, timing, and the cost of lupus trials. Here’s how:

• Direct input during the patient visit – This makes it possible to correct discrepancies and complete missing information immediately, which might only have been discovered long after the patient left the clinic in paper-based assessments. Automatic edit checks also prevent out-of-range entries and skipped fields, leading to fewer queries between the data monitors and the site.
  
• No duplicate entries or transcription needed – Investigators need only enter data into the tool once, as repeated information will automatically populate the required fields. There is also no need to transcribe the data from paper forms into an EDC system, eliminating the need for source data verification (SDV).

• A streamlined flow of data to the study team – Before the patient leaves the clinic parking lot, the data can be uploaded to the portal for review by:

• Adjudication teams to make prompt decisions on patient eligibility. 
• Medical safety teams to spot any adverse reactions to the study drug or manifestations of lupus that are potentially life-threatening.
• Data monitoring teams to begin the appropriate queries.
• Data management teams with a real-time dataset.

Our Direct Data Capture software for clinical trials is efficient for both sites and study teams. Not only does it eliminate transcription and SDV, it also reduces the number of data queries and removes the time lag to complete datasets. In sending cleaner and more complete data to study teams, the tool reduces study timelines, bolsters sponsor confidence, and brings clarity to market authorization decisions. 

The patient is at the center of all these advantages. Our system provides patient outcomes with the highest confidence available, which is our goal with each clinical trial we have the opportunity to serve. If you’d like to find out more about the eLAS® suite, please contact us.

Authors

Will Combs
Partner Alliance Director, Clinical ink

Doug Pierce
President & Co-Founder, Clinical ink

The post Transforming Lupus Trials with Direct Data Capture appeared first on Clinical ink.

The foundation of the data collection is a customized PPD version of Clinical ink’s proprietary electronic Lupus Assessment Suite (eLAS^®). Using eLAS^® simplifies investigator and patient participation in clinical trials and provides pharmaceutical industry customers with near real-time access to SLE endpoint data.

“Combining PPD’s team of SLE operational and clinical experts with Clinical ink’s proprietary eLAS^® solution enables us to offer near real-time access to critical SLE endpoint data,” said Carol Olson, M.D., Ph.D., vice president and head of global product development at PPD. “This consolidated approach addresses one of the most important challenges in SLE studies related to the variability of placebo response and improves efficacy signal detection. It also enables us to conduct a central review of key data by a dedicated team, enhancing the accuracy and consistency of our results.”

“The assessments used in SLE clinical trials are complex, subject to wide variability and not routinely used in everyday rheumatology clinical practice,” said Doug Pierce, president of Clinical ink. “These complexities make operationalizing SLE trials incredibly difficult. By bringing together this custom version of eLAS^® with PPD’s dedicated expert review team, we are combining efforts to deliver new and enhanced capabilities for customers who are developing new SLE treatment options.”

Clinical ink’s eLAS^® is a therapeutic-specific application of its Lunexis platform, featuring a fully integrated suite of SLE disease assessment questionnaires and patient-reported outcomes that are completed by clinicians and patients. With eLAS^®, investigators enter patient data once and the system automatically populates the appropriate fields across the required assessments, reducing redundant data entries and errors, which saves time and enhances site efficiencies.

Unlike other applications that simply offer stand-alone electronic versions of questionnaires, eLAS^® features a fully integrated suite of SLE disease assessment surveys, physical evaluations, tender/swollen joint counts, physician global appraisals and summary forms. The system ensures that adequate, relevant documentation is in place to support the investigator’s findings and disease assessment scoring. The Lunexis platform provides immediate access to data for PPD’s review of trial eligibility prior to enrollment, as well as validation of questionnaire data collected at subsequent visits.

PPD has a dedicated group of experienced professionals with extensive SLE expertise, including board-certified rheumatologists with industry and in-house experience in site personnel training, eligibility confirmation, efficacy data review and safety monitoring. From lab data integration to customized dashboards providing visualization of eLAS^® data, PPD’s central review process employs both innovative applications of technology and trained expert medical reviewers who use centralized monitoring techniques as well as traditional data review processes to detect and resolve data issues at the patient, site and study levels to ensure high levels of accuracy and consistency.

About PPD
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

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.

PPD Contact
Media:
Randy Buckwalter
+1 919 456 4425
media@ppd.com

Investors:
Tracy Krumme
+1 910 558 4186
investors@ppd.com

This news release contains forward-looking statements. These statements often include words such as “expect,” “believe,” “project,” “forecast,” “estimate,” “target” and other similar expressions. Although we believe these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our actual financial results, and therefore actual results might differ materially from those expressed in the forward-looking statements. Factors that might materially affect such forward-looking statements include, but are not limited to, the fragmented and highly competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to keep pace with rapid technological changes that could make our services less competitive or obsolete; political, economic and/or regulatory influences and changes; and other factors disclosed under the “Risk Factors” section in our periodic reports filed with the Securities and Exchange Commission (SEC), including our latest Annual Report on Form 10-K, which is available on our website at https://investors.ppd.com or the SEC’s website at www.sec.gov. We assume no obligation and disclaim any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.

The post PPD and Clinical ink Collaborate on Innovative Process for Lupus Assessment and Near Real-Time Access to Endpoint Data 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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