IQVIA’s data-driven trial execution is designed to drive efficiency, enhance data quality and align with progressive industry best practice. This approach to risk based monitoring and integrates patient data from multiple sources, allowing rapid identification in response to signal and trends in real-time which helps as:
1. Proactive risk mitigation.
2. Faster and more informed decision.
3. Improved patient safety.
4. Enhance data quality.
Medical professional and their responsibilities:
A team of medically trained professional conduct subject level reviews by analyzing patients, sites and study level data from multiple sources. These professional are responsible for certain number of patient assigned to them for data reviewing, individually per trial and their duty is follow the patients for the life of the study having longitudinal data and ability to integrate information across sources allows them to understand patterns better and to judge the arising abnormality. The medical data review process seeks to ensure subject’s data is medically congruent and sound for both the intra and inter subject.
Patient’s vital signs:
By examining the patient’s vital signs, medial professional can notice that the both diastolic and systolic blood pressures appear to be increasing with time. He checks the data of patients in his cohorts and discovers if the pattern of data is not unique.
· In order to reach the root cause, he raises the alert via centralized clinical operation team.
· Along with trial data, these professional also have the access to lab data where they can also find any variations as an escalation in live function test, this allow them to give alert signal.
CPM alert dashboard:
Project manager of the study can get the full picture for what’s happening in their study globally in real time by opening his CPM alert dashboard where he can drill down by country, region and sites and can see all the alerts have been fired. This is a lot quicker and efficient way of site monitoring.
· This is a lot better way as compared to past traditional site monitoring by CRA who has to visit sites for every forty eight hours depending upon the protocols.
· This reduces the time to review reports and to find any site quality issues.
· This approach helps the manager to manage and focus on their time, resources and energy in a much more dynamic and clinically relevant way.
Duties of CRA:
CRAs start their day at work by looking at their sites to see whether if there are any alerts. They can find out if the results of any patients are out of range that can be due to an error in data or a safety signal. They make sure to aware the site in case of any issues.
· CRAs having support from centralized monitoring team allow them to engage with their sites in an impactful way. This help them to work together in order to understand the data and be proactive in identifying and resolving questions that can improve data quality and enhance patient safety.
This IQVIA centralized monitoring approach helps to reveal, recognize and handle the data over night that used to take months in past.