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Webinar: Ensuring Quality and Risk Mitigation with Proactive Planning in Clinical Trials

Tuesday, February 11, 2020  |  1:00-2:00 pm EST

 

Emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a 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?

 

In this webcast, we 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

 

Presenters:

 

Crissy MacDonald

Executive Director, Client Delivery

The Avoca Group

As leader of the Avoca Group’s Integrated Consulting and overseer of the Avoca Quality Consortium workstreams, Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across The Avoca Group. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development, and strategic management. Crissy earned a PhD in biomedical engineering from Drexel University and a bachelor’s degree from Lafayette College.

 

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.

 

Jonathan Rowe

Associate Principal, R&D Excellence

ZS Management Consulting

Since 1996, Jonathan Rowe has worked within the pharmaceutical industry to develop medical therapies from the clinical, operational, and business perspectives. Jonathan currently holds the position of Associate Principal, R&D Excellence at ZS Associates, where he focuses on the pharma sector. From 2014 to 2019, Jonathan was the Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities included 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 was built into all trials. He also held a number of other 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.

 

This webinar is co-sponsored by:

   

The Avoca Group is a life sciences consulting firm dedicated to improving quality and compliance in the clinical trial execution process.  Integrating deep subject matter expertise with industry-leading approaches and technology, we tailor solutions that help companies build industry-leading quality management, inspection readiness, and effective oversight systems into existing processes.

   

Oracle Health Sciences breaks down barriers and opens new pathways to unify people and processes to bring new drugs to market faster. As a leader in Life Sciences technology, Oracle Health Sciences is trusted by 29 of the top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs for managing clinical trials and pharmacovigilance around the globe.