Press Releases | Tigermed

The system platform “Clinical Trial Quality Risk Monitoring Method, Device, Computer equipment and Storage medium” in-house developed by Tigermed group, was recently awarded the Invention Patent Certificate authorized by the State Intellectual Property Office, realizing another important breakthrough in indigenous R&D technology and innovation-driven strategy.

Since the U.S. Food and Drug Administration took the lead in recommending the adoption of risk-based monitoring (RBM) in 2013, regulatory agencies in various countries have also revolutionized the monitoring approach, advocating the adoption of RBM or more comprehensive risk-based quality management (RBQM), and China has also released a new version of GCP in 2020 and mentioned RBQM (Article 31), clearly proposing the adoption of a systematic, risk-based approach to clinical trial monitoring. China also released a new version of GCP in 2020 and mentioned RBQM (Article 31), clearly proposing to adopt a systematic, risk-based approach to clinical trial monitoring.

One of the major benefits of using RBQM is that the system can directly contribute to the quality, efficiency, and the speed of clinical trials. Since the adoption of the centralized monitoring approach, the hours required for each on-site monitoring have been consistently reduced by an average of 20%. According to Tigermed’s practices and other survey findings, RBQM has consistently shown that cost savings can be ultimately achieved by early detection of data anomalies, shortened data management cycles, accelerated database locking, reduced lag in subject visit data entry.

The Tigermed RBQM team embarked on a major innovation project to develop a system platform. After more than three years of exploration and construction, Tigermed was authorized with its first RBQM invention patent. This patent provides direct benefits to the quality, efficiency, and speed of clinical trials. At the organizational level, Tigermed now offers a service portfolio that includes modules for risk assessment and management, centralized monitoring, and adaptive monitoring. It has also developed solutions and supporting systems that are applicable to multi-regional clinical trials all over the world.

The Tigermed's RBQM system is a digital-driven and data analysis platform. The platform provides computerized system validation and features customizable clinical data analysis with visualization capabilities. Its main functionality includes centralized monitoring, analyzing clinical and operational data to identify outliers, risk trends, and data anomalies. Also, the RBQM platform encompasses risk assessment and monitoring functions such as key risk indicators and study metrics, along with risk detection features like data quality assessment and data visualization.

Drug R&D is evolving to an intelligent stage, and digital innovation has become the most important factor in advancing drug R&D. Tigermed RBQM team will take this patent acquisition as an opportunity to enhance technology innovation and to promote the application of patent achievements, also set up SOPs internally from the organizational level and clinical trial level, drive the RBQM business with a standardized digital technology platform with high quality and efficiency, and illuminate the road to the future of new drug development with innovative tools.

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