WHITE PAPER
Clinical trials for lupus treatment are a vital part of lupus research and assessment, but these trials are affected by extensive documentation requirements. Technology offers a solution.
Immunology
The Data Capture Solution for Immunology Trials
Immunology clinical trials often target patients with complex, chronic conditions that are difficult to diagnose and treat. Identifying and enrolling eligible patients is challenging. Keeping them engaged throughout a trial is even more so.
Immunological diseases are multifactorial, often caused by a combination of genetic, environmental, and lifestyle factors. Trials involve treatments that manipulate the immune system, which can sometimes lead to serious side effects.
Leveraging its eSource technology, Clinical ink has designed a solution that helps capture and manage large, unstructured, and highly complex amounts of data, while monitoring patient safety in real-time.
Data Solutions to Improve Quality, Safety, and Efficiency
Among immunology studies in complex therapeutic areas, Clinical ink developed the electronic lupus assessment technology (eLAS®), a fit-for-purpose Systemic Lupus Erythematosus (SLE or, more commonly, Lupus) data capture and patient engagement solution.
Making SLE research straightforward, efficient, and reliable, eLAS® solves the issue of aggregating and analyzing multiple questionnaires, which are often duplicative yet feature differing symptom scoring criteria.
eLAS® leverages Clinical ink Direct Data Capture (DDC) technology to share information between questionnaires and forms. It displays prompts that clarify the proper evaluation methods for any particular questionnaire and integrates functionalities to validate data in real time.
Why eLAS® for SLE and Immunology Trials?
Capture Everything, Everywhere
A single tool for online or offline data capture, including eCOA, unstructured supporting data (numeric, text, VAS, audio, video, and handwritten notes).
Simplify
Communication
Easier patient communications for more efficient data gathering.
Easily Understand Data Entry
All screens are based on familiar documents.
Optimize Decision-Making
Consolidated reports and instant access to uploaded charts help provide research teams with more reliable data.
Powering Your Immunology Trials
Using eSource and fit-for-purpose eLAS® technology, time-consuming manual activities and the errors of traditional paper methodologies are eliminated, including managing, reconciling, and validating multiple questionnaires and forms.
Study teams and investigators realize significant benefits for clinical trial data analysis and collections:
Pre-program Workflows
and Study Processes
Ease site burden with reminders, calculated data, training, and other study-related information.
Minimize Follow-Up Queries and Reduce Workload
Real-time edit checks with pop-up data entry reminders; corrections can be made while the patient is still present.
Immediate Access to Assessments and Data
Gain access to all pre-randomization eligibility review data quickly and easily.
Immediately Validate Data
Data validation at the time of capture—only enter data once.
Instant Web-Based Data Reports
Study team has data available immediately.
Share Data Efficiently
Across protocol-required questionnaires and visit histories.
Simplify Every Step of Your Immunology Trials
Collecting quality data for immunology clinical trial data analysis is problematic—so much so that only one therapy has ever been approved for SLE.
With Clinical ink eSource technology, every step is simplified. Pre-programmed workflows and study processes give reminders, calculate 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 can access the complete chart. Reports with consolidated data are immediately available.
Medical data review and adjudication teams have immediate access to core lupus assessments and all supporting data, including handwritten notes, for pre-randomization eligibility review. Earlier review and validation of scoring reduces the delay in response generation and resolution compared to paper scales transcribed into EDC solutions. It also streamlines the adjudication process by providing real-time access to study data.
The Clinical ink electronic Lupus Assessment Suite (eLAS®) is the industry’s first data capture system specifically designed as a scalable solution to streamline lupus clinical trials.
