Learn how PerkinElmer’s clinical solutions give clinical operations organizations the unprecedented ability to reduce the time, cost and risk of running clinical trials while accelerating the time to market for products across the entire portfolio of clinical candidates.
The adoption of RBM is increasing as companies provide greater management support, staff training and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards and applications will allow issues to be identified and addressed early, improving study safety and efficiency.
Proponents of RBM projects believe that the investment in this approach will return an overall reduction in monitoring expense by 15 to 20 percent. This paper discusses RBM as a high-value use case that can be enhanced by a robust clinical data aggregation and analytics solution.
Drug developers are focusing significant attention on risk-based monitoring (RBM) of clinical trials to improve data quality, trial efficiency and patient safety. Widely encouraged by regulatory agencies, RBM adoption is gradually building momentum as sponsors and contract research organizations (CROs) concentrate on developing the right strategies, deploying the most effective technologies and internally managing change.
Achieve clinical trial operations excellence using this an innovative solution that gives clinical operations organizations the unprecedented ability to reduce the time, cost, and risk of running clinical trials while accelerating time to market for products across the entire portfolio of clinical candidates.
Gilead Sciences’ previous studies of Ranexa (ranolazine) relied on data from exercise treadmill parameters as the primary endpoint. But collecting data in this manner is costly, logistically challenging, and bears questionable clinical relevance — especially at the individual patient level. Learn how Gilead Sciences successfully utilized ERT handhelds to collect regulatory-compliant, patient-driven data in support of the primary efficacy endpoint in a Phase IV study of Ranexa.
The objective of this study was to compare the equivalence of a new version of the electronic Columbia-Suicide Severity Rating Scale that was administered on a tablet device. The results supported the validity and reliability of the new tablet-based electronic Columbia-Suicide Severity Rating Scale and allow its inclusion in a wider range of clinical studies, particularly where a tablet is also being used to collect other study data.
A biopharmaceutical company wanted to determine whether patients treated with an oral inhibitor of phosphodieasterase-4 (PDE-4) would show improvement in signs and symptoms of PsA. They used ERT eCOA tablets to collect data about patient symptoms as observed by physicians through the ACR assessment which was used to assess efficacy. Results showed reduced monitoring time and costs, decreased time to database lock, and FDA approval.
Clinician rater training has been shown to be effective in improving rater reliability in dermatology studies. Rater training effectiveness and engagement are enhanced when COA data are collected electronically, with customized assessment training on ERT eCOA tablet and web. The ERT Clinical Science Team customizes clinician rater training for each dermatology assessment, with the help of Dr. Callis Duffin. Together with ERT clinical psychologists, Dr. Callis Duffin has established a gold standard for training raters on the PASI. Download this ebook to learn about the gold standard for training clinician raters, the ERT PASI assessment quizzing and scoring, and PASI electronic implementation training.
The importance of patient-reported outcomes (PRO) is evidenced by their increased use in clinical trials and in drug and device label claims. In many cases, the best way to measure symptoms and functional status is through insights provided by the patient, but few people know how to go about integrating ePRO into their clinical trials. Download this white paper to learn about a completed a Phase 2 clinical trial that used electronic PRO for the first time and identified the key decision points, responsibilities and lessons learned for incorporating ePRO into clinical trial practices.
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