Mapping the Way Forward: How Can We Get Real-Time Data in a High Volume Clinical Trial?

From time to time, we like to feature questions from our clients in our DSN blog. This series, called Mapping the Way Forward, is intended to share information that may benefit other clients. Here is the latest question we received from a DSN client sponsor in the clinical space.

Q: “Our client is setting up a COVID trial with an expected high volume. They would like analytics that focus on very specific end points and allow real-time analysis to identify important safety information. Are there any enhanced reporting capabilities from DSN that can provide this information to us in a timely manner without manual manipulation?”

A: Great question! Yes, DSN has developed a Safety Analytics Dashboard for our clients to utilize who are engaged in these types of studies. Knowing that medicinal products can have different effects on certain populations, gathering data by gender, age, ethnicity, risk factors, etc. allows for identification of clusters of events, outcomes, or other previously unidentified signals. And as the dashboard provides real-time analysis, Sponsors can make more informed decisions regarding the safety of the IMP. Additionally, it allows for the generation of presentable graphs customized by the selected data elements.

There are 5 standard recommended dashboards that can be customized with a Sponsor’s specific needs. This includes data elements like SMQ’s, Concomitant Medications, and Medical History.

For example, if you want to analyze data for your COVID trial, we utilize a dashboard that has specific endpoints which include points such as ICU transfer, ventilator support, intubation all within one interactive report.

Reach out to us at info@drugsafetynavigator.com to learn more about our interactive dashboard and the additional reports that can be customized and used. Talk to you soon!

If you have a challenging pharmacovigilance question, please send us a note at info@drugsafetynavigator.com and we’ll feature it in an upcoming DSN blog.