Our Mission: Accelerating Clinical Trials
Our Mission: Accelerating Clinical Trials
Accelerating clinical trials and improving outcomes is our mission. According to industry research, more than half of all clinical trial query stoppages result from preventable human errors, causing an average delay of up to seven weeks.
AG Mednet recognizes that the current system is imperfect, and in response created Judi //, the clinical trial technology platform improving workflow, ensuring compliance and accelerating outcomes. Users of the Judi platform gain a new level of automated quality assurance, reducing submission error rates and bring preventable delays to zero. This technology is the first quality assurance software built specifically to detect errors at the investigator site prior to data submission in order to accelerate clinical trial decision-making.
Judi serves participants across the clinical trial continuum, delivering technology and value for endpoint/adverse adjudication challenges, and workflow and QA tools for imaging-based trials for all involved in the process. Judi serves:
Sponsors rely on extensive data points to make critical assessments about the viability of a therapy and clinical trial. If data points are missing, delayed, or inaccurate, decisions sit in limbo. Judi identifies preventable errors that delay clinical trials and creates a system for careful, organized, and precise data capture. Through the use of custom roles, sponsors can walk the fine line between knowing the general state of their endpoint adjudication projects and maintaining a barrier that avoids introducing bias into the process. Judi can deliver a variety of reports including FDA compliant closeout packages with all the required details to ensure proper regulatory filings.
Core Labs (ICLs)
Core labs help pharmaceutical companies reach critical “go- or no-go” decisions faster. Judi immediately detects errors that result in queries, forcing acknowledgement of the query and allowing the ICL to expedite the transfer and analysis of critical data, assuring that submissions are correct and evaluable based on the clinical trial protocol.
Adjudicators and Committees
Judi provides adjudicators with robust dossiers and advanced eCRFs, enabling them to perform their evaluations and vote, as well as an ability to request additional information from the trial manager. Adjudicators can work asynchronously and, if desired, can be provided with an ability to reevaluate their decisions under circumstances defined by the sponsor and the CRO.
Clinical Research Organizations (CROs)
CROs manage, design, monitor and report on all aspects of clinical research trials including patient enrollment and participation. Judi gives CROs a system to verify information, automatically update support systems including EDC (electronic data capture), and dramatically reduce the amount of queries returned for correction or re-scanning. Trial managers take advantage of a global view of their project, seeing at a glance the state of every event in the system. Additionally, tools to QA documents, send them for translation, aggregate them into dossiers and manage their adjudicators’ workload enable the managers to keep processes running efficiently. With an ability to communicate directly with sites as well as adjudicators and committees, CROs can for the first time keep track of their entire endpoint adjudication workflow and report on the status of all activities at the push of a button.
Principal Investigators (PIs)
Clinical trial investigators are leading researchers dedicated to improving drug therapies and patient outcomes. Preventable errors stall clinical trials and impact ongoing patient participation. Judi helps PIs manage compliance more easily and accurately than ever before possible, and significantly reduces the overhead required to manage queries long after data has been submitted. Trial coordinators around the world benefit from an intuitive interface that facilitates completing the collection of event-specific documents, deidentifying them and submitting them for review and dossier aggregation. A powerful query management system, together with a highly configurable notification capability, ensures that tasks don’t linger and processes can move efficiently.