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Utilizing A Data-Driven Approach to Risk-Based Monitoring
PAREXEL® Informatics knows the most confident time to make a decision is when all the facts are clear. Perceptive MyTrials® Data-Driven Monitoring not only gives you the data you need, but organizes it in a new and meaningful way that makes decision-making easier and faster. Plus, it monitors your actions throughout the course of clinical trials so you can prove best-practice and follow-through. You get more than just the data you need. You get peace of mind.
View our short video and see how our Data-Driven Monitoring solution can enable easier and faster decision-making.
Part of the Perceptive MyTrials® framework, Data-Driven Monitoring provides a combination of risk-based monitoring, adaptive monitoring and centralized monitoring. Our solution leverages clinical operations data to guide the monitoring activities that are carried out with any given site, as an alternative to regular, scheduled monitoring visits.
Data-Driven Monitoring enables you to:
• Make data-driven decisions around site monitoring activities
• Perform cross-study analysis of quality, risk and monitoring
• Reduce on-site monitoring activities and the associated costs
• Improve patient safety and data quality
• Prove to regulatory authorities that adequate monitoring is being performed
Risk-based monitoring of clinical sites has been gathering in momentum in the past few years. Following FDA guidance on the subject, software providers are now developing systems more sophisticated and intuitive by the day. Jo Shorthouse, Scrip 100 Editor, talks to PAREXEL Informatics about our approach to the subject.
The suite is greater than the sum of its parts. Learn why we are driven by
the need to make life easier for those conducting clinical trials.
Clinical Leader reached out to Camie Britton, Senior Director, Strategic Account Management for PAREXEL International to learn more about the benefits of centralized monitoring and to gain insight into best practices for implementing centralized monitoring at investigative sites.
Learn how simplifying workflows and delivering superior user experiences, the DataLabs EDC solution's advanced features help streamline the entire process.
IMPACT CTMS yields immediate efficiencies and cost savings for clinical operations.
Clinical Trial Management System (CTMS)
Electronic Data Capture
The DataLabs® EDC (Electronic Data Capture) solution is uniquely focused on simplifying workflows and delivering superior user experiences. Its advanced EDC features help streamline the entire process starting from study design all the way to collection, management and reporting of clinical trial data.
Randomization and Trial Supply Management
PAREXEL® Informatics provides automated randomization and supplies management through its ClinPhone® RTSM (Randomization and Trial Supply Management) solution. Our services are offered by the industry's most experience and trusted provider of IVR (Interactive Voice Response) and IWR (Interactive Web Response) technologies.
Electronic Clinical Outcome Assessments (eCOA)
Clinical Outcome Assessments (COAs) measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions. COAs can be used to determine whether or not a drug has been demonstrated to provide treatment benefit. COA types include ePRO (electronic Patient Reported Outcomes).