Per the partnership, Triumph Research Intelligence (TRI) will provide risk-based monitoring (RBM) services to the contract research organization (CRO) Veristat.
TRI’s RBM platform, OPRA, improves data reliability, patient safety, and operational efficiency, according to the company.
A spokesperson for TRI told us that OPRA is a cloud-based solution designed for RBM specifically. It uses data from multiple sources and employs statistical algorithms and data visualization to provide insights to the centralized monitoring team.
“Based on the efficacy of the risk detection and management, the approach can be adjusted as the trial progresses to ensure an optimal approach to quality management at all times,” the TRI spokesperson explained.
A spokesperson for Veristat said that by providing these services to its clients it can provide support to optimize clinical trial data quality from “the very start of their trial.”
This technology allows sponsors to quickly identify areas of quality risk and allows CROs like Veristat to target onsite-monitoring activities.
“Just identifying risks isn’t sufficient. Proactively managing those risks through improvement activities, and recording and monitoring whether corrective activities are effective, is key to demonstrating trial safety and efficacy,” said Veristat’s spokesperson.
According to Veristsat, through this type of risk monitoring, data quality assurance is built right into the trial. The company also said that the partnership ensures compliance through creating bespoke key risk indicators (KRI’s) and key performance indicators (KPIs) that are specific to each trial. This technology will ensure regulatory compliance and improve patient safety, according to the company.
ICH GCP E6(R2)
Since the US Food and Drug Administration (FDA) issued the International Council for Harmonization’s (ICH) Guideline for Good Clinical Practice (GCP), otherwise known as ICH GCP E6(R2), clinical trial design compliance has been an important consideration. Under these specifications management and oversight, patient safety, data integrity, and computer system validation must meet the guidelines laid out as a way to improve efficacy and efficiency.
ICH GCP encourages the adoption of risk-based practices in clinical trials.
“It’s important to note that compliance with the ICH GCP lies with both the sponsor and with Veristat,” said the Veristat spokesperson, adding, “With RBM, through the collection of relevant metrics, appropriate data-driven decision can be made which can help to drive safety and better quality data.”