Regulatory & Compliance

Breakout Session V & VI – Regulatory & Compliance, Recruitment & Retention
September 2, 2020 • 0 Comment

1:30 – 2:30
Risk-Based, Centralized, Remote Monitoring, Say What? Quality Control, Explained

If centralized and remote site monitoring (RSM) were not yet on your radar, the COVID-19 pandemic brought it to your doorstep. But what exactly are they and what do they mean for sites? Further, how does all this relate to risk-based monitoring (RBM)? In this session you will hear lessons learned from experience and understand what sites should expect as a site from the future of monitoring.

2:30 – 3:30

Sustaining Patient-Centricity Amidst Adversity

Achieving patient centricity is easier said than done, yet it is important that all stakeholders strive to remain patient-centric even when the going gets tough. This session will highlight how stakeholders maintained patient centricity through the COVID-19 pandemic, including strategies deployed and the resulting outcomes.

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Breakout Session III & IV – Regulatory & Compliance
September 1, 2020 • 0 Comment

1:30 – 2:30
Quality Management: Not Only the Sponsor’s Responsibility!

ICH guidelines put the responsibility of quality management squarely on the sponsors’ shoulders. But that doesn’t mean sites shouldn’t have their own quality management plan! Understand the importance of quality management at the site level and learn how to set up your own quality management plan.

2:30 – 3:30

eSolution Innovation & Regulatory Considerations

Implementing eRegulatory, eSource and other patient-facing technology that allows clinical trials to move to a remote or hybrid model is on the rise. This is thanks in part to COVID-19, yet this path was paved long before the pandemic began. Join this session to understand the hurdles encountered by those who have already adopted these technologies, and navigate the related regulatory considerations.

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