PPD, Inc. (Nasdaq: PPD), a leading global contract research organization, and Clinical Ink, a global clinical technology company, have jointly developed a systemic lupus erythematosus (SLE) assessment review process to simplify operationalizing clinical trials for this chronic autoimmune disease. The companies’ collaborative approach focuses on enhancing data quality and research site personnel experiences and efficiencies, in turn supporting pharmaceutical industry clients in developing new SLE treatments.
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.
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. For more information, visit www.ppd.com.
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. For more information, visit www.clinicalink.com.
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