BOSTON, Dec. 11, 2019 /PRNewswire/ — Patient enrollment is one of the most expensive and delicate aspects of a new clinical trial. Judi // Eligibility, the newest offering within AG Mednet’s clinical trial SaaS platform, streamlines central eligibility review workflows in trials, and aggregates data to quickly achieve a final determination. The result is a trial with an accurate group of eligible patients enrolled within an appropriate timeframe.
Clinical trials face a consistent shortage of subjects. Coupled with the likelihood of patients dropping out of a trial, choosing the right subjects for any study may represent the difference between a successful trial and an unsuccessful one. Trial managers and investigator sites must adhere to a strict patient acquisition process within a short, measurable time period. Clinical trial protocols include increasingly complex inclusion and exclusion criteria, which makes an efficient, central review of eligibility by an independent third party more vital than ever to a trial’s success.
Judi // Eligibility is designed to help manage the eligibility screening process, giving role-specific visibility to the different constituencies involved in order to achieve an accurate and timely eligibility determination with full transparency and audit trail. Judi // Eligibility can be used in standard and customized configurations with workflows that can be chosen at the outset of a trial to determine eligibility. These configurations include straight line, single decision point or dual, concurrent evaluations with a possible tiebreaker. The platform provides eCRFs, dashboards, reporting and interaction tools that make the process efficient and predictable – and more successful.
Though customizable, Judi // Eligibility is configured to be useable out-of-the-box. Standard configuration includes the following:
- Dashboards for final decisions, document management and queries
- PHI redaction tools for documents and medical images
- Reports including performance statistics, time parameters and site data
- Workflows to view all candidate submissions, role-to-role communications and branded eCRFs for required process states and decisions
“Judi // Eligibility automates and manages a challenging area of clinical trials – finding the right patients to make an accurate determination about the potential success of a new therapy,” said Abraham Gutman, president and CEO of AG Mednet. “Enrolling the wrong patients disrupts data and slows a trial down. Until now, there has not been a way to centralize the decision-making process around patient recruitment and to implement checks and balances, so the trial and its sponsor have the right patient mix to move the trial forward. Judi // Eligibility solves that.”
AG Mednet also offers automated workflow solutions with Judi // Imaging, which is used to securely collect and store clinical trial imaging data, Judi // Adjudication, which helps manage end-to-end clinical event and endpoint adjudication workflows, and Judi // DSMB, which automates data safety monitoring board activities, providing a consistent and reproducible DSMB process.
SOURCE AG Mednet