Prelude EDC Reduces Clinical Timelines for Pivotal Aratana Study
By Tommy Jackson on February 9, 2015
Aratana Therapeutics, Inc. (PETX) announced on December 18th the positive, statistically-significant (p < 0.05) results from its pivotal field study of AT-001 (Grapiprant), the company’s innovative drug for treating pain in dogs with osteoarthritis. This was just the latest pivotal clinical trial to use the Prelude EDC electronic data capture system, developed by Austin-based Prelude Dynamics and it was key to the conduct of the study.
“Using Prelude EDC to monitor the data in real-time, search data and create reports within the system to monitor progress was definitely instrumental in making the study run smoothly and efficiently,”
said Dr. Johnny Jacobsen, Chief Operating Officer at AlcheraBio LLC, the clinical research organization that managed the study. Study sites and AlcheraBio personnel find Prelude EDC intuitive and easy to navigate.
“Prelude EDC’s strength is its ability to automate the intricacies of the study for complex protocols beyond what sponsors typically expect,”
said Prelude Dynamics CTO, Dr. Alicia Browner. Prelude EDC has a library of customizable features that allow for these expedited timelines. For Aratana’s AT-003 study, assessments could be selectively hidden from view of the assessor when complete; integrated inventory-tracking streamlines the drug reconciliation process; Con Meds and AEs are cross-referenced; complex cross-form constraints and calculations are easily configured. All information is easily accessible directly on the page that holds the data, such as queries, notes-to-file, errors, and audit trail. Real-time remote access to data enables Monitors to query specific data, automatically notifying the site to review and respond. This built-in exchange allows data reviews to occur much closer to the actual data collection time.
“The fact that Aratana was able to lock the database and release their results simultaneously shows the quality of the data they collected and analyzed using Prelude EDC” said Richard Tieken, Prelude Dynamics CEO.
This allows for studies to consistently close out months ahead of schedule. Where it may have taken months to clean and lock the entire data set, with Prelude EDC it takes days. Prelude’s services have benefited sponsors in hundreds of human, companion animal, and food animal clinical trials in all Phases, across 25 countries, in multiple languages with hundreds of sites and thousands of patients.