The Development of a Disease-Specific eCOA/ePRO: The Electronic Lupus Assessment Suite

Only one drug specific for systemic lupus erythematosus (SLE) has been approved thus far. This is because for sponsors and CROs, recruiting the right patients and collecting quality data for lupus clinical trials are notoriously difficult. This webinar covers a new disease-specific application of Lumenis™ called eLAS. This is an integrative, powerful form of electronic clinical assessment (eCOA) that addresses the fundamental challenges of SLE research to accelerate the development of new treatments for this underserved group of patients.

This webinar will discuss the reasons why lupus research is so complex and how a comprehensive solution such as the eLAS platform can overcome the challenges of complex clinical trials when customized to address the idiosyncrasies of a specific therapeutic area, such as SLE, through features that:

• Eliminate conflicting data and duplicative entry requirements by presenting easy-to-understand data entry screens that walk users through pre-programmed workflows and study processes, give instructions, calculate data and provide training

• Minimize queries through real-time edit checks with pop-up data entry reminders so corrections can be made while the patient is still present

• Share data across the protocol-required questionnaires and visits, as well as formulate it into reports to make it immediately available to study team members through a web portal

• Allow clinicians to enter structured and non-structured data including numeric, text, VAS, audio, video and even handwritten notes for complete documentation

No matter how complex the trial type or protocol is, an eCOA application purpose-designed with the right functionality and services can vastly reduce site workload and improve site performance, data quality and the overall likelihood of successful study completion.

While this webinar focuses on lupus, this concept can be applied in any area and specific platforms for other areas, such as GI, CNS, dermatology, and others are in development.

Speakers

Doug Pierce, President, Clinical Ink

Doug Pierce co-founded Clinical Ink in 2007 to revolutionize clinical trials by eliminating the complexities and costs associated with paper-based data capture processes. In his role as president and co-founder, Pierce brings more than 20 years of experience in digital forms technology and mobile data capture to lead the strategic direction, development and evolution of Clinical Ink’s eSource suite.

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Kyle Hogan, VP, Outcome Solutions, Clinical Ink

Kyle Hogan is responsible for the strategic alignment of the company’s native mobile application for ePRO/eCOA and patient engagement in clinical trials. He has delivered technical solutions for complex business challenges since the 1990s and has 15 years of experience in clinical trials. Hogan has managed numerous, global ePRO trial deployments and has been instrumental in the development of Clinical Ink’s mobile solutions for patient-centric ePRO/eCOA. A recognized industry expert in this area, he regularly helps sponsors realize BYOD-capable solutions for clinical trial data collection.

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