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Ensuring Quality and Risk Mitigation with Proactive Planning in Clinical Trials

Craig Morgan
Head of Marketing, Study Startup

Emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall. With unrelenting pressures to rein in budgets and cycle times, stakeholders are turning to quality as a solution, starting with building it into study startup and bringing change to entrenched silos that stall trial operations.

Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance and audit-readiness, and in order to avoid serious budget and timeline overages which can derail a study resulting in costly rescue interventions, often due to issues that are preventable.

Good Clinical Practice guidelines (ICH-GCP E6(R2)) state that sponsors should implement a system to manage quality throughout all stages of the trial process, including process and data identification, risk identification, evaluation, communication and more.

But how do these guidelines and systems improve overall study quality?

Please join us for this webcast:

Live: Tuesday, February 11, 2020

1pm EST | 12pm CST | 10am PST

On Demand: available after airing until February 11, 2021

This webcast will explore:

  • The importance of proactive planning and fundamentals of effective study startup
  • How automated workflows encourage upfront planning and downstream improvements
  • Why an upfront emphasis on quality in study startup is essential
  • How the ICH-GCP E6(R2) guideline defines quality management and builds on the foundation of regulatory documents released by the EMA/FDA
  • Why breaking down organizational silos is critical to reducing quality issues
  • Leading practices for sponsors and CROs

This webcast is applicable to:

  • Sponsor and CRO roles responsible for quality management
  • Sponsor and CRO roles responsible for application validation and deployment
  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for project management of studies and operational excellence

Panelists:

CRISSY MACDONALD, Executive Director, Client Delivery, The Avoca Group

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.

JONATHAN ROWE, Associate Principal, R&D Excellence, ZS Management Consulting

Since 1996, Jonathan has been working within the pharmaceutical industry to develop medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Associate Principle R&D Excellence at ZS Associates where he is focusing on the pharma sector. From 2014-2019 Jonathan was the Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer's Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At 15 years at Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in "small pharma" as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his PhD and MS at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

ELVIN THALUND, Director, Industry Strategy, Oracle Health Sciences

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 Oracle Health Sciences 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.

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