Risk Assessment: You can't Manage what you don't Measure

Risk Assessment: You can't manage what you don't measure

Risk should not lead to decision making paralysis

Risk is our constant companion. As clinical trials grow in complexity, so do risk-based challenges to bring new therapies to market. The process of initiating clinical trials, collectively known as study startup, is cumbersome, challenging and fraught with delays. Study startup has an impact on patient recruitment, trial duration and associated costs, unfortunately, it is the worst performing stage of any study.

A practical risk management methodology enables stakeholders to identify clinical trial issues early on, which in turn allows for the design of effective mitigation strategies before risks materialize. Risk mitigation is therefore optimal using systems which can provide timely, preferably real-time data on trial bottlenecks, which indicate red flags to be reviewed and addressed or at least tracked carefully throughout the trial. With the help of leading practice guides, tools, templates, and automated workflows for study startup, Sponsors and CROs can proactively conduct risk management.

In this webinar, co-presented with the Avoca Quality Consortium, leading practices for proactive risk management in starting clinical trials will be shared. Participants will learn how to effectively conduct risk management in the initialization clinical trials to ensure adherence to timelines, budget and overall quality.

In this webinar, we will explore:

  • The importance of automating document workflows (i.e., alerts, ensuring regulatory/SOP compliance, role-base assignments, etc.) in risk management
  • The need for standards and performance metrics in risk monitoring
  • The identification of red flags and the importance of real-time metrics to drive timely interventions
  • Project reporting with milestone tracking and re-projection
  • Improving collaboration with transparent communications, the cornerstone of any good risk management plan

This webinar is applicable to:

  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for collecting and evaluating trial metrics
  • Sponsor and CRO roles responsible for project management of studies

Presenters:

Crissy MacDonald
As leader of Avoca's Integrated Consulting, Crissy provides consulting to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from preclinical research through late-stage clinical development.

Crissy earned a Ph.D. in biomedical engineering from Drexel University and a bachelor's degree from Lafayette College.
CRISSY MACDONALD
Executive Director, Client Delivery
The Avoca Group
Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in goBalto’s effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.
ELVIN THALUND
Senior Director, Industry Strategy
goBalto
Elvin Thalund

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