Risk-Reduction Practices in Clinical Trials

CQMS (Clinical Quality Management System) is designed to manage all of the documents, activities, project tasks, processes, quality events, risk considerations, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The CQMS is completely designed to increase efficiency and reuse of information while streamlining the processes and tasks that must be executed during the length of a clinical trial. Unlike traditional Clinical Trial Management Systems (CTMS) that focus exclusively on data collection and documentation, the CQMS goes beyond these areas and includes a holistic approach to managing quality and risk throughout the clinical trial.

A CQMS provides an integrated approach to managing clinical information derived from various areas such as:

  • Study management
  • Site management (site qualification, site documents, IRBs, history, etc.)
  • Project management (milestones, visits, status, etc.)
  • Risk management (reporting, analytics, risk-based processes, etc.)
  • Vendor management (CROs, IP distributors, etc.)
  • Document management
    • Electronic trial master file (eTMF) document management
    • Document exchange (partners: CROs, sponsors, sites)
    • 3rd party collaboration
  • Document control
    • Good clinical practice (GCP) document control
    • Automated training task deployment
  • Quality event management
    • Site monitoring
    • Protocol deviation management
    • Clinical CAPA management
  • Audit management (study, sites, vendors, etc.)
  • Training management (GCP, protocol)
Areas Covered in the Session :

  • The Risk management approach to clinical trial development
  • Context of risk in clinical trial management
  • The connection of the deviation spectrum to risk, data analysis and process resolution which includes change control
  • Description of an action-based risk planning matrix
  • Tools/resources used to support the risk-analysis process
  • The difference between risk assessment and risk analysis in process application
Who Should Attend:

  • R&D Teams
  • Clinical Trial Management
  • Marketing
  • CRO’s
  • Ops Clinical Management
  • Clinical Trial Investigators
  • Clinical Trial Auditors
  • Everyone that are required to participate in teaming of Clinical Trial Management

FDB2393

Walter E. Murray

Walt Murray is the CEO of ARCexperts (Audit/Risk/Compliance), providing expert consulting and training for technical science-based companies. He serves as an independent consultant with multiple clients in Pharma, Medical Device, IVD and retail consulting on regulated products. He has an extended network of healthcare, software and food & beverage team consultants.

Walt Murray is a management systems (OEHSMS) and regulatory affairs (QA/RA) professional with more than 32 years of experience working with internationally recognized, highly regulated companies in automotive, aerospace, chemical, medical device, biomedical and pharmaceutical sectors. A Six Sigma Black Belt, Walt is certified (CSSMB) in quality and environmental systems auditing (CLA), Critical-Thinking Skills (CTS), Process Control and as a PMO. He also has extensive training and consulting expertise in Quality Event (QEM)/CAPA management, risk management, supplier control and audit management.

Having personally performed more than 350 1st/2nd/3rd-party audits, for a variety of Fortune 500 companies as well as hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (CMDR) due to vast knowledge of regulation and guidance documentation and quality standards. This includes guidance on the MDSAP process for auditing.

Walt holds a Bachelor of Science degree in analytical chemistry from the University of Richmond, VA and has completed graduate-level coursework at the University of Tennessee, Knoxville (Deming School). He is an active member of the Society of Manufacturing Engineers (SME), the Regulatory Affairs Professional Society (RAPS), the American Society for Quality (ASQ) and the Society for Quality Assurance (SQA). He was the founding Executive Director of the Mfg. Council of the Central Valley of CA.(MCCV).

Walt has assisted in the strategic development of Enterprise Software with validation support in life science companies. He recently lead the quality and compliance consulting services division of MasterControl®, a leading provider of quality management software enterprise to regulated companies worldwide. His broad knowledge base makes him a sought-after speaker at national and international compliance forums. He is a Vietnam Veteran where he served as a corpsman and certified laboratory technologist.

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