Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
Today MCC released its groundbreaking, in-depth report on risk-based monitoring practices, “Taking the Risk-Based Monitoring Plunge: Who’s doing it, how they’re approaching it, and the metrics they’re using to manage it.” This survey represents another unique and valuable addition to an already rich and growing portfolio of metrics, performance-enhancing services, publications and tools offered to MCC members.
The new RBM Report released today gives current RBM users the ability to compare the RBM methods they currently employ to those utilized by a large sample of biopharmaceutical, CRO and academic research organizations. It gives new RBM users information that will allow them to accelerate and focus their implementation. The report includes over 40 figures, tables and graphs covering a wide range of topics including:
· Which types of organizations are undertaking RBM in which trial phases and regions
· The methods and approaches being used including, central data analytics and on-site monitoring strategies
· The typical and preferred metrics being used to trigger on-site monitoring visits
The report includes a detailed evaluation of RBM approaches compared to expectations set forth in the final FDA Guidance on RBM, and puts the MCC survey into context by comparing and contrasting its results with other recent industry surveys.
“This report helps both new and seasoned RBM users improve and focus their RBM efforts. This furthers our goal of helping companies within the industry understand, adopt and utilize metrics to drive performance quality and improvement,” stated MCC CEO David Zuckerman. “Today’s announcement is yet another example of our efforts to make MCC metrics more useful and relevant to the right users at the right time”.
The new MCC RBM Monitoring study is available for purchase through MCC.