In a world with COVID-19, remote monitoring is now essential to effectively monitor studies. Sponsors and CROs are either adapting to this new state of affairs or updating the already existing process based on complications unique to COVID-19 (site closures or reduced site access).
Remote monitoring requires more than one solution to complete this task. One of the tools Pharm-Olam utilizes to support our remote monitoring work is Medidata’s Rave Centralized Statistical Analytics (CSA) tool.
What is Rave CSA?
Medidata Rave CSA is a data insights tool designed for the unique demands of clinical trials. It offers streamlined data aggregation, analysis with visualization suite. Rave CSA works by importing data from the various clinical trial data sources (EDC, Lab, Imaging, eCOA/ePRO, etc.) involved in your study, and then it applies machine learning and statistical algorithms to yield data insights. These insights can be in the form of data anomaly detection, monitoring of key risk indicators (KRIs) and data point health / quality checks.
Rave CSA displays the status of research data at the patient, site and study level using visual dashboards. Its system automatically evaluates data sets and assigns a grade based on the perceived quality of the data entered.
Another way that Medidata Rave CSA supports remote monitoring is through Patient Profiles. Patient Profiles provide a more holistic view of the individual patient/subject. This is incredibly valuable to your medical monitoring team for monitoring the health and safety of patients involved in your study as well as the quality of the data being entered.
Key Risk Indications
Rave CSA includes a function called Key Risk Indicator (KRI). This KRI Table incorporates study data with site trends so CRO project team members and Sponsor staff can see whether any key indicators are going in a negative direction. This allows timely corrective measures to be deployed early on before your study and its data is impacted severely, possibly jeopardizing the value and use of your study with regulatory authorities.
The Need for Remote Monitoring
The need for remote monitoring is not confined to conducting studies in pandemics. While research in the time of COVID has certainly benefited from remote monitoring technology, there is a variety of reasons why remote monitoring is rapidly becoming a feature of modern clinical trials.
Conclusion - Rave CSA Empowers Remote Monitoring
Sponsors and CROs need tools that empower remote monitoring and study oversight. Utilizing Rave CSA, as one of the tools in our remote monitoring tool kit, allows Pharm-Olam and our Sponsors to see the full picture in regards of data quality, from the study, site and patient level. When less time is going to be spent on site, this critical tool can provide confidence that the quality and safety of your study is going to be maintained and that you have an efficient and reliable tool to monitor it along the way. To learn more about Pharm-Olam's use of this technology and how it can benefit your clinical trial, speak with our team today.