GCP WEBCAST SERIES
How to Optimize Clinical Quality During a Global Pandemic
JULY 7–9, 2020 VIRTUAL EVENT
As the world adjusts to the new normal of a global pandemic, clinical research has continued to try and find a way to fight this virus. Ensuring trial integrity as processes and operations are disrupted by new safety mandates, poses significant challenges. We've developed a three-day event featuring perspectives from varying stakeholders as they share their experiences optimizing clinical quality during these trying times.
Registration is complimentary for professionals from pharmaceutical, biotech, and medical device organizations. Others are welcomed to register for a small fee which gives you full access to all three days. We anticipate this being an interactive live experience, so greatest value will come from being there the day of the event.
TUESDAY, JULY 7
EXPERT PANEL: HOW TO ASSURE CLINICAL QUALITY DURING AND POST-COVID
Discuss What the “New Normal” Could Look Like for Clinical Trials and Strategies for Optimizing Quality in This Different Environment
- Has COVID forever changed clinical trials?
- What are effective approaches to assuring quality in the new environment?
- What is an “audit” when entry to sites is banned and planes don’t fly?
- Remote Audits – How can we do better than replicating the traditional site audit?
- How can the new reality drive to truly paperless records?
- How do we overcome the things “you have to see for yourself,” like informed consent, IMP integrity and accountability, and the paper site files?
CASE STUDY PRESENTATION
Determine Risk Assessments for Continuing Clinical Studies During a Pandemic and Current Update on Their Status
- Understand the principles and objectives of risk-based approaches in clinical research
- Learn strategies for engaging and orienting teams to the process
- Delve into details of a clinical trials risk assessment during the COVID-19 pandemic
- Consider initial outcomes from the risk assessment and the path forward
WEDNESDAY, JULY 8
TRAINING THE NEXT GENERATION OF QUALITY PROFESSIONALS
Understand Why It’s More Important Than Ever to Develop Quality Professionals That Can Identify Quality Issues That Matter
- Set the tone for change in your organization
- Evaluate your audit data to determine what signals it is (or is not) providing
- Identify what skills and attributes are needed from our quality professionals of the future
- Change the mindset of quality professionals from “QCing” others work to strategic, risk-based thinking
- Ensure your quality professionals are prepared to navigate a rapidly changing research environment
EXPERT PANEL: THE VIRTUAL CLINICAL WORLD
Overcome Technology, Process and Behavior Barriers as We Shift to Virtual Trials and Remote Audits and Inspections
- Discuss the impact of the global pandemic on clinical data, operations and people
- Evaluate the sudden shift to virtual and remote technology options and the impact on clinical data integrity
- Identify the process and conceptual obstacles to virtual and remote options and how to overcome them
- Understand the site perspective and what is needed to facilitate efficient remote and virtual options
- Strategize on technology options and solutions to streamline remote monitoring and virtual inspection
THURSDAY, JULY 9
EMERGING COMPANY CASE STUDY: HOW TO PANDEMIC PROOF YOUR CLINICAL TRIAL
Identify and Leverage Available Resources to Shift to a Study Model that Can Withstand a Pandemic
- Learn from Palvella Therapeutics as they share their story of successfully pivoting their study to a functional model that can work during a pandemic
- Understand when they took action in response to COVID-19
- Discuss the use of home health providers, local testing facilities and telehealth capabilities
- Evaluate which endpoints can be completed by the patient in their home or in their community
- Examine how clinical trials will change moving forward
CLINICAL TRIAL RESILIENCE AND EFFICIENCY
Small Companies Can Survive the Lockdown and Future Proof Trials Post COVID-19
- Accelerate decision making and documentation during lockdown
- Optimize trials through risk assessment and strategic monitoring plans using available resources
- Reduce trial fragility and exposure to global events
SITE REGULATORY DOCUMENTATION QUALITY
Automate Remote Review of Essential Site Documentation to Optimize Quality During a Pandemic and Beyond
- Evaluate the inefficiencies of the current manual process of site document review
- Outline efficiencies to be gained and costs to be saved, with automated monitoring of site documentation
- Develop a strategy for automation that involves all stakeholders
- Share realized benefits from case studies of this new approach to quality control
MID-STUDY SHIFT FROM FULL SDV TO REMOTE RISK-BASED MONITORING
Streamline the Transition from Full Source Data Verification (SDV) To A Risk-Based Approach
- Evaluate and document the risks of the study
- Determine the important components of a risk-based approach and the transition plan
- Document and ensure inspection readiness
THE NEW MONITORING MODEL
Utilize Resources Available to Small Companies to Conduct Remote Monitoring During COVID and Beyond
- Identify what things need to take place to conduct remote monitoring
- Evaluate the site’s remote monitoring readiness with an assessment checklist
- Do they have external EMR access?
- Discuss the necessity of a shared file area (SFA) platform
- Determine what actions need to be taken to implement using available tools
- Oversee and follow-through to ensure remote monitoring is effective
PANEL DISCUSSION: PROACTIVE RISK MANAGEMENT AT EMERGING COMPANIES
Implement Compliant Risk Management Approaches With Limited Resources in a Remote/Virtual Clinical World
- Understand how COVID-19 has impacted clinical risk management at companies with limited resources
- Examine how risk management has been modernized in response to the pandemic
- Leverage risk management to predict GCP risk and the impact on monitoring and auditing planning
- Describe an approach for identifying important questions to ask about a protocol that can identify risk