The global pandemic altered the course of clinical trials, accelerating industry efforts to change how trials are conducted. The shift to decentralized trials, remote visits, virtual experiences, and faster regulatory reviews requires the industry to embrace new ways of operating, and take a fresh approach to how technology is deployed, how stakeholders collaborate, how administrative tasks can be simplified and automated - ultimately, drive greater efficiency in clinical trials and accelerate the industry's move toward patient-centric healthcare.
The urgency of the COVID-19 pandemic has forever changed the drug development industry. Globally biopharma companies were challenged to react rapidly and intelligently to adapt ongoing clinical trials for a socially distant environment. Looking beyond the pandemic, it seems like designing trials with pandemic speed and innovation is here to stay. Patrick Floody, Senior Director, Global Study Strategy & Optimization at Regeneron, will review how Regeneron created efficiencies leading to novel breakthroughs over the past year and how the company plans to maintain their high standard of scientific rigor.
Is it coincidence or is it systemic? How does a clinical research program determine if clinical study issues identified are systemic, or worse yet, lead to an audit finding? Examine a case study whereby a clinical research program developed a tracking process for clinical study issues in order to trend those issues and make decisions with the goals of preventing audit findings and foster continuous improvement in clinical studies. Attendees will be provided with a basic framework for tracking and trending clinical study issues, and real-world examples of how data trending could prevent future study issues or audit findings, as well as improve their overall clinical study conduct.
Organizations that participate in clinical research activities face a complex and highly regulated industry. For Clinical Research Departments, understanding the regulatory compliance risks associated with clinical research is essential for everyone– including executive management (c-suite) to avoid significant non-compliance penalties from the federal and state governments. Discover how implementing a Proactive Compliance concept to a CRRC program is the most advantageous way of addressing regulatory matters for an institution.
No one wants to work across twenty systems, remember one hundred passwords, or duplicate work between different software packages. But far too often, this is the result when disparate technology solutions are adopted at research sites and an integration strategy is not put in place. In this engaging session, you'll learn how to harness the power of best-in-class software while avoiding digital fatigue, duplication, and wasted time. What do you do to make sure integrated workflows are part of the system from day one? Which processes or workflows should you tackle first? How do you work with sponsors to reduce technology overload while still getting the benefits of advanced solutions? We'll answer these questions and let you in on the secrets other organizations are using to build the integrated research site of the future.
NOTE: This session does NOT offer ACRP Contact Hours.
Funding for research continues to constrict, successful organizations must continuously improve, innovate and advance. Integration of research administration functions from grants and contracts, clinical operations, to regulatory oversight through IRB/IACUC/IBC is crucial to ensure your programs are organized and working together to support research. And integration doesn’t always mean new technology, most improvements can be implemented with people and programs.
In this session, we will share success stories and provide practical tips on how to accomplish better integration in your research program.
Mitigate risk and improve regulatory compliance with insider advice from FDA officials and industry experts.
This online, interactive program features FDA officials and industry experts addressing CDER BIMO compliance and enforcement, FDA inspections, ClinicalTrials.gov requirements, and more.
Explore key opportunities for the clinical research industry to make the FDA inspection experience a positive one. Hear inspections' impact on applications and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.
Explore what it takes to be ready for the figurative knock on the door from FDA. Examine FDA Inspections and how to prepare for the inevitable knock, discuss available resources, and review responses received from 483s.
Meeting regulatory compliance requirements can be strenuous and drain a site’s resources. This session shows that achieving regulatory compliance is primarily a collaborative exercise, involving coordination and partnership between multiple roles and stakeholders, sites as well as their technology solution providers. In the changing landscape of research, sites can reduce compliance risks and achieve new efficiencies by using a comprehensive and unified research management ecosystem including electronic paper binders, EDC, remote patient engagement and data monitoring capabilities.
This session is presented by WCG Velos and the University of Kansas Medical Center.
NOTE: This session does NOT offer ACRP Contact Hours.