Signal Detection Services
One of the challenges in conducting clinical trials is the large number of clinical data points that make up the activity and safety information. In this data there may be safety trends hidden that are not made obvious by simply looking at tables and listings, or events may emerge which reveal a safety challenge. In addition, that data often arrives with delay because of the need to capture, process and display the data after periodic “data transfers.” Due to these challenges, this safety and activity data must be constantly monitored and processed in real time with an eye towards risk management and abatement.
Clinipace’s digital CRO (dCRO) Signal Detection Services (SDS) provide patient visualizations of all patient safety data as well as the ability to detect events of special interest for further signal analysis that is available to the sponsor and the CRO alike, using the same real-time clinical information. These periodic cross functional impact analyses are enabled by our TEMPO™ eclinical platform and supported via expertise, including:
- Medical Monitor
- Safety Case Manager
- Informatics (i.e., biostatistician, statistical programmer, data manager)
Real-time data availability in one database is critical to quickly capture outliers, trends or parallel changes in clinical parameters. Having these abilities at your fingertips allows focused attention on those parameters or events that stand out.
The TEMPO platform efficiently maintains the verbatim and medically coded AE/SAE terms, concomitant medications and medical history as base level CRF data. Traditional safety data reconciliation—often time consuming and thus diminishing the time available to produce safety reports to FDA or other health authorities—is not necessary in the TEMPO environment. SAE case processing and submissions are supported within TEMPO, therefore not requiring duplicate SAE entry into a traditional safety database.
Get your critical data more efficiently
The SDS organization provides outputs necessary for safety reporting including, but not limited to, production of CIOMS, MedWatch and submission-ready E2B (XML). In addition, SDS provides visualizations that provide for intelligent signaling by getting data in your hands sooner, enabling you to efficiently identify events of interest that could affect the safety risk benefit product profile. Such analyses can serve as exhibits for advisory boards and safety committees.
Study and patient level data visualization
Aggregate study level visualizations provide a powerful tool for safety committees to allow for expert analysis of site and subject level data variables at periodic intervals to detect potential safety issues much earlier in the lifecycle development of the product.
Advisory Boards and executive decision makers can be informed earlier at proactive intervals of important emergent product risk benefit data to enable them to quickly make decisions regarding patient safety.