US contract research organisation PPD and clinical technology company Clinical Ink have jointly developed a systemic lupus erythematosus (SLE) assessment review process.
This process is said to simplify the operationalising clinical trials for SLE, which is a chronic autoimmune disease.
Under the partnership, the companies seek to enhance data quality and research site personnel experiences and efficiencies and thereby, support pharmaceutical industry clients in developing new SLE treatments.
A customised PPD version of Clinical Ink’s proprietary electronic Lupus Assessment Suite (eLAS) has been used as the foundation of the data collection.
eLAS is designed to simplify the investigator and patient participation in clinical trials and offers pharmaceutical industry customers with almost real-time access to SLE endpoint data.
PPD vice-president and global product development head Carol Olson said: “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.
“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.”
Clinical Ink’s eLAS is a therapeutic-specific application of its Lunexis platform. It features a completely integrated suite of SLE disease assessment questionnaires and patient-reported outcomes that are completed by clinicians and patients.
Investigators can enter patient data using eLAS. The system will then automatically populate the appropriate fields across the required assessments, thereby reducing redundant data entries and errors.
Compared with other applications that simply provide stand-alone electronic versions of questionnaires, eLAS features a suite of SLE disease assessment surveys, physical evaluations, swollen joint counts, physician global appraisals and summary forms.
Furthermore, the Lunexis platform offers quick access to data for PPD’s review of trial eligibility before the enrolment, and validation of questionnaire data collected at subsequent visits.
Clinical Ink president Doug Pierce said: “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.”
Last year, PPD extended its digital clinical trial capabilities to support biopharmaceutical firms’ research continuity initiatives in response to the Covid-19 pandemic.