Toggle Mobile Navigation

7th CROWN Congress in Applied Clinical Trials’ Interview With CQI Consulting President

Thank you to Applied Clinical Trials for mentioning our 7th CROWN Congress in their interview with previous CROWN Congress speaker Arti Bajpai, President of Compliance and Quality Integration (CQI) Consulting.  ExL’s 7th CROWN Congress is occurring on January 23-25, 2018 in Philadelphia. In this new interview, Bajpai describes Quality Management Systems (QMS) and how it connects to Risk-Based Monitoring (RBM).

“A simple way to think of QMS is the connectivity and flow from internal strategy supported by robust processes, tools, and qualified people working in harmony,” the CQI Consulting president explained to Applied Clinical Trials. “Collection and analysis of quality and performance metrics enable data-driven course adjustments and decision making within an organization. A well-established QMS can help drive towards an organizational culture of compliance. QMS, when implemented effectively, can inform the organization on potential enterprise and study level risks and allow informed decision making for managing those risks.”

She continued: “Risk-Based Monitoring in the clinical trials space implies that one must understand the risks within a given program to develop risk-based monitoring and mitigation plans. In my assessment, RBM is a component of a fully functioning QMS. At the onset of RBM, its intent and impact [were] misunderstood. However, biopharmaceutical enterprises now understand that to know what to monitor using the RBM approach, they must first identify the risks in program and study design and implement a risk mitigation plan, thereby utilizing the concepts of Quality by Design (QbD). In addition, it should be noted that the investigative sites are a critical partner and have direct impact on successful outcomes and in quality of clinical data. The concepts described in this paper can be adapted by the Investigators sites to improve upon their deliverables.”

Bajpai goes on to explain more and answer additional questions in this informative interview. To find out more on this topic from an industry professional and previous ExL speaker, read more right here!

posted in ExL Events News
tagged with

live chat software