Risk-Based Monitoring

The biopharmaceutical industry must establish customized approaches to managing Quality Management Systems within their clinical trials processes.

Centralized monitoring is the core of RBM and helps study teams decide on on-site monitoring activities and site intervention. Thus, the right mix of KRIs and Central Statistical Monitoring Reports is crucial for trial success.

The pharma industry needs an improved risk-based management approach to better handle the increased complexity of trials, to improve the quality of studies and to better adhere to new guidelines from regulatory agencies.

The ICH is publishing its long-awaited guidelines on how to conduct clinical monitoring in trial management. Sponsors and CROs can integrate existing and emerging technologies while transforming their reactive oversight strategies to an RBM approach using these steps.

Risk-based monitoring continues to remain in the spotlight as an accepted and oft implemented approach that is likely to become an industry standard. However, concerns have mounted about the potential impact of these changes on clinical study sites.

Investigational sites’ readiness to support new monitoring initiatives such as risk-based monitoring and centralized monitoring will dictate their success. Here are key aspects that sponsors and CROs should establish with investigational sites while implementing these new initiatives.

This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 3 covers the value of embracing a centralized, technology driven approach to risk based monitoring.

Many have inquired about writing an RBM plan due to recent changes in industry execution and an increase in RBM experiences. Moe Alsumidaie responds with a brief methodology on developing a risk management process to create an RBM plan.

A risk-based approach to quality trial oversight, adopted by the FDA and EMA, has resulted in an array of new technology solutions being released.

RBM and changes in quality management are impacting study teams, CRAs and sites.

With the introduction centralized monitoring in a risk-based monitoring (RBM) approach, the central monitor is emerging as a key and important role.

Good clinical trial risk management involves good protocol design and study operational design at the sites.

Using the five steps to a risk management plan from other industries--Identify, Assess, Plan, Track and Control--to inform a RBM approach in clinical trials.

Infinity Pharmaceuticals will use Medidata's RBM solution in an upcoming Phase III oncology study for patients with indolent non-Hodgkin lymphoma.

TransCelerate’s Risk Assessment and Categorization Tool (RACT) has exhibited usefulness with study teams and has guided organizations, such as Cancer Research UK (CRUK) to adopt their own RBM questionnaires

CBI’s conference proves RBM was just the beginning. Now companies are honing in on the risks and mitigations related to clinical trial data reporting.

The ability to have access to real-time information through leveraging technology combined with a strategic business perspective allows companies to implement a true quality management system.

Investigator sites in emerging markets have a different set of challenges from those in developed regions. They cater to significantly larger patient populations, and are often not as well organized for clinical trial conduct.

While we become empowered with the technological enablers of centralized and statistical monitoring, it can be challenging to envision the respective functions of DMs and CRAs.

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OmniComm Systems, a global provider of clinical data management technology, announced survey results from respondents that included 16 sponsor organizations and 13 contract research organizations (CROs).

 Quintiles announced the addition of advanced statistical monitoring and predictive analytics capabilities to its risk-based monitoring (RBM) solution. Predictive and Advanced Analytics provide model-based capabilities are fully integrated into the solution and are underpinned by Quintiles Infosario® technology platform. These new capabilities are intended to improve precision in risk identification by better understanding underlying “white noise” from safety trigger processes. 

CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach.