Linking Study Quality to Leading Practices for Proactive Planning
Building in quality can lead to transformational process changes
A well-known cliché advises that if you fail to plan, you are planning to fail. When it comes to study startup these words ring true, especially as the clinical trials sector is making strides in boosting study quality. With the help of leading practice guides, tools, templates, and automated workflows for study startup, Sponsors and CROs can proactively plan. These stakeholders can agree on and document key elements that can drive quality, efficiency, and compliance while reducing risk and cycle time. These elements enable organizations to document decisions and operational practices to allow sponsors to use a more balanced approach for CRO oversight, and allow CROs the autonomy to effectively meet and exceed sponsor requirements. This proactive approach is becoming essential to enabling parties to constantly be audit-ready, and to increase the likelihood of positive regulatory inspection outcomes.
Getting it right from the beginning — prior to site activation — is key. Too often, these issues are not addressed upfront, resulting in inefficiencies and problems that are not identified until much later, when the study is already underway. Reversing this trend means building in quality from the start. This approach aligns with regulatory initiatives to manage risk, leading to improved study quality.
In this webinar, co-presented with the Avoca Quality Consortium, leading practices for proactive study startup planning will be shared. Participants will learn how to effectively deliver on improved overall study quality while supporting regulatory compliance for provider oversight.
In this webinar, we will explore:
- The importance of proactive planning
- Fundamentals of effective study startup
- Key considerations prior to site activation
- Leading practices – for Sponsors and CROs
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
Janis Hall is a Senior Consultant with The Avoca Group. She has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO, and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), she was responsible for R&D sourcing, contracting, and supplier alliance management.
As Senior Consultant with The Avoca Group, Janis developed many of the quality oversight tools within the Avoca Quality ConsortiumTM Knowledge Center. She is also the mastermind behind the Oversight Capability and Maturity Model (OCMM) and Prequalification work streams, and a key contributor to Avoca's DiligentTM Vendor Prequalification Platform.
Janis has been a chair, invited speaker, and panelist at numerous conferences. She holds an MBA from the University of Delaware and a BS in Chemistry from Towson University.
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.
Senior Director, Product Strategy
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