eLAS® (Electronic Lupus Assessment Suite) for Systemic Lupus Erythematosus Clinical Trials

eLAS® (Electronic Lupus Assessment Suite) for Systemic Lupus Erythematosus Clinical Trials

While it’s true that all clinical trials have challenges, studies in certain therapeutic areas such as Systemic Lupus Erythematosus (SLE or, more commonly, lupus) can be particularly difficult to conduct. Because lupus is characterized by an aggregate of symptoms, diagnosis can be difficult.[i] This makes screening and data collection during research studies even more complex.

Lupus research uses multiple questionnaires, often duplicative yet with differing symptom scoring criteria. By sharing information between forms and displaying prompts that clarify the proper evaluation methods for that particular questionnaire, the Clinical ink direct data capture solution (DDC) can help make investigators’ lives easier and ensure correct protocol execution.

Comprehensive Solutions That Improve Quality, Safety, and Efficiency

Our fit-for-purpose electronic lupus assessment technology (eLAS®) facilitates data collection and patient engagement, helping make SLE research straightforward, efficient, and reliable. Not only is the right functionality to enable data corrections made before patients leave the facility, but time-consuming manual activities and the errors associated with traditional paper methodologies are eliminated.

Investigators realize significant benefits deploying eLAS® technology for clinical trial data analysis and collections:

  • Capture Everything
    A single tool for capturing all clinical trial data, including eCOA, as well as unstructured supporting data (numeric, text, VAS, audio, video, and handwritten notes)
  • Immediately Validate Data and Reduce Workload
    Data validation at the time of capture – only enter data once
  • Share Data Efficiently
    Across protocol-required questionnaires and visit histories
  • Easily Understand Data Entry
    All screens based on familiar documents
  • Minimize Follow-Up Queries
    Real-time edit checks with pop-up data entry reminders; corrections can be made while the patient is still present
  • Instant Web-Based Data Reports
    Study team immediately has data available
  • Simplify Communication
    Easier patient communications for more efficient data gathering
  • Pre-program Workflows and Study Processes
    Ease site burden with reminders, calculated data, training, and other study-related information
  • Optimize Decision-making
    Consolidated reports and instant access to uploaded charts help provide research teams with more reliable data
  • Immediate Access to Assessments and Data
    Gain access to all pre-randomization eligibility review data quickly and easily
  • Capture Data and Documents Offline
    Clinical ink tools are designed to work even if you’re offline

Simplifying Screening and Data Collection

With Clinical ink technology, pre-programmed workflows and study processes give reminders, calculated data, and provide training and other study-related foundational information to ease site burden.

As soon as the patient leaves the examining room and their chart is uploaded, the entire study team has access to the complete chart, and reports with consolidated data are immediately available.

Medical data review and adjudication teams have immediate access to the core lupus assessments and all supporting data, including handwritten notes, for pre-randomization eligibility review. This enables earlier ongoing review and validation of the response scoring,reduces the delay in response generation and resolution compared to paper scales transcribed into EDC solutions, and streamlines the adjudication process by providing real-time access to the study data.

Collecting quality data for lupus clinical trial data analysis is problematic — so much so that only one therapy has ever been approved for this disorder. Clinical ink’s electronic Lupus Assessment Suite (eLAS®) is the industry’s first data capture system specifically designed as a scalable solution to streamline lupus clinical trials

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