This package is a replay of the ACRP 2021 Virtual Program. It includes the following sessions:
The rise of COVID-19 has fast-tracked the call for innovative clinical trial solutions and about whether the traditional Sponsor-PI-Patient centric model is sustainable. Discussions of an alternative model, hybrid clinical trials, would combine elements of both centralized and decentralized systems while also leaving the door open for new technologies. But what should the patient experience in a proposed hybrid model? What could the role of advanced technology such as AI, digital patient recruitment and mobile apps be? How would decision-making and stakeholder collaboration be impacted? Explore these issues and discuss best practices you can implement in 2021. Speaker: Al O. Pacino, II, President & CEO, BlueCloud by HealthCarePoint
When the world is changing by the minute in the middle of a pandemic, you hold on tight and get ready for a wild ride. Join this session to learn how to expand research operations utilizing remote technology and existing resources and how the Medical University of South Carolina used this approach to activate a COVID-19 study in our rural research naive hospitals in under one week. Hear lessons learned and how the team adapted and overcame barriers to ensure the needs of the community were met. Speakers: Amanda Cameron, MPH, CPH, CCRP, Trial Innovation Network Program Manager, Medical University of South Carolina, Signe Denmark, MS, CCRP, Associate Director Research Opportunities & Collaborations, Medical University of South Carolina, and Amy Gandy, SCTR Laboratories Manager, Medical University of South Carolina
Explore decentralized clinical trials (DCT) and the oversight role of the sponsor. During COVID-19, many trials have been modified and changed to account for the inability to interact with subjects in person and many organizations have moved to a decentralized architecture. Session participants will: understand the regulations pertaining to decentralized clinical trials, learn the perceived benefits and challenges of a DCT, and discuss remote monitoring of DCTs. Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West), FDA
Staff cuts. Furloughs. Realignments of roles and responsibilities. Pivoting to new SOPs and technologies. Remote work as the “new normal.” COVID-19 caused major disruptions in the clinical research workforce. In this panel session, leadership from sites, sponsors, and CROs will share what they learned while navigating this unprecedented workforce shake-up. They’ll share changes that were thrust upon their teams, what worked, what didn’t – and most importantly, the potential lasting impacts the pandemic is likely to have on the workforce. Speakers: Asha Collins, Head of US, Country Clinical Operations, Genentech, Jennifer Sheller, Regional Head, North America – Clinical Trial Country Operations, Merck, and Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center
Examine the coverage analysis and budgeting process, and how it interfaces with the contract negotiations in this interactive session providing tools and tips to implement right away. Speakers: Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager, Kelly Willenberg & Associates, and Deena Bernstein, MHs, SVP, Network Partnerships, Circuit Clinical
Hear straight from the experts that executed rapid study start-up and study management using a ‘no touch’ protocol while under quarantine, stay at home orders. The panel will share their real-world experience on rapid study deployment and lessons learned in developing and initiating two large randomized clinical trials studying the effects of hydroxychloroquine in outpatients with confirmed COVID-19 in under two weeks. Speakers: Jeri Burr, MS, RN-BC, CCRC, FACRP, Executive Director, Utah Trial Innovation Center, University of Utah, Dr. Nina Pacchia, PhD, CCRC, Program Director, University of Utah, and Sam Sorenson, BS, CCRC, Project Manager III, University of Utah
Join senior site, sponsor, and tech provider experts to explore clinical trial technology and how it does and doesn’t “fit in”. Discuss how sites and sponsors are using technology today and over the next few years; when site and sponsor tech can be complimentary and/or in conflict; what competencies are needed for successful adoption and resources available for support; and how we can all work together to improve experience and study outcomes. Leave with an understanding of all three perspectives and ideas for how you can support their own organization’s preparedness. Speakers: Elisa Cascade, Executive Vice President, eCOA, ERT, Mohammed Ali, VP Digital Analytics and Performance, GSK, and Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, CSM, Chief Operations Officer, IACT Health
An estimated 20% to 50% of protocols close with zero-accrual at the site level and up to 90% of studies have extended recruitment periods at the overall study level. This results in considerable waste of limited and expensive resources, increases staff and investigator frustration, and compromises scientific findings and ethical standards. Utilizing a protocol feasibility review process that assesses the ability to accrue participants, complete the study procedures, allocate staff resources, and achieve financial goals is necessary to efficiently run clinical trials for any organization. Get the knowledge you need to consider such a process within their clinical research operations and maximize trial efficiency. Speaker: Wendy Tate, PhD, GStat, Director, Research Operations, Forte, now part of Advarra
Explore how a virtual environment is impacting the monitoring of clinical study data and the relationships between sites, CROs, and sponsors. Examine a variety of critical remote monitoring issues that can help ensure trial success. Key takeaways include: Site recruitment strategies to ensure remote monitoring is feasible; Remote monitoring regulations and guidelines; Implementation of new technology to facilitate remote visits; Redaction and upload of source documents; Communication tips between sponsors, sites, and CROs; Maintaining the integrity of study data; Electronic data capture systems and study database modifications. Speakers: Nicole Tierney, CCRA, BA, Principal Clinical Research Associate, NAMSA, and Suzanne Sullivan, RN, CCRA, Manager, Clinical Research Services, NAMSA
This session will examine the operating environment for clinical trials prior to, and during the pandemic. Process adaptations and innovations, many supported by virtual and remote practices and technologies, will be discussed. Based on past and current research on industry practices and evolving patient preferences, the session will also explore pandemic response solutions that have the highest and lowest likelihood of becoming standard practices. Speaker: Kenneth A. Getz, MBA, Director of Sponsored Programs, Professor, CSDD, Tufts University
Decentralized clinical trials (DCTs) have quickly become the “new normal” over the last year. What role do sites play in the success of DCTs in the long term? What do patients want to see? How should we all work together for success? Can DCTs deliver on their promise of improving research access and facilitating greater participant diversity? In this session, we will discuss this topic with members of Parexel’s Patient and Site Advisory Councils, and share learnings and actionable steps on how to successfully execute a DCT and ensure the best result from a site, patient, and sponsor perspective. Speakers: Rosamund Round, Vice President, Patient Innovation Center, Parexel, Agnieszka Gackowska, MD, Senior Director, Global Site Solutions, Parexel, Mohammad A. Millwala, MBA, CPA, CCRP, CEO, DM Clinical Research, and Trishna Bharadia, Health Advocate and Patient Engagement Champion
The objective of a clinical trial is to collect quality clinical data that can be used to show efficacy and safety. Every day, clinical study coordinators, data managers, monitors, medical monitors, and others work to collect quality data to support this purpose. Explore how this process works and get helpful tools and tips for improving the process and making it easier from the perspective of each functional stakeholder: data management, site coordinator, medical monitor, statistician, and clinical research associate. Learn how each function can improve this process while relieving stress and frustration. Speaker: Steve Pope, MSHS, CCRP, Senior CRA, PRA Health Sciences
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. Speaker: James Reilly, MBA, Vice President, Veeva
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. Join Regeneron’s expert to learn how the company created efficiencies leading to novel breakthroughs over the past year and how the company plans to maintain its high standard of scientific rigor. Speaker: Patrick Floody, Patrick Floody, Senior Director, Global Study Strategy & Optimization, Regeneron
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. Speakers: Mary Veazie, MBA, CPA, CHC, CHRC, Executive Director, Clinical Research Finance, The University of Texas MD Anderson Cancer Center, and Erika Stevens, MA, Principal, Recherche Transformation Rapide
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. Speaker: Lisa Haney, BS, CCRC, Senior Clinical Quality Specialist, Medtronic
Funding for research continues to constrict successful organizations that 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 ensuring 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. Speaker: James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Institutional Services, Advarra
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. Speaker: David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA
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. Speaker: Eric Pittman, Director, Bioresearch Monitoring Division (West), FDA
The first right of the patient after consenting to participate in a clinical trial is the right to withdraw this consent. However, a consent withdrawal may have several forms and consequences, and understanding the underlying reasons behind a consent withdrawal may affect the steps to be implemented for a proper follow-up and return to routine practice. This session will bring communication keys to site personnel to properly interact with patients willing to opt-out from a trial, taking into consideration safety aspects, protocol compliance, and data protection aspects. Speaker: Hubert Lesur, CCRC, CCRC, GCP-QA Auditor, HL Health Support
Conflict happens in all clinical trials management setting. Having a self-awareness and ability to recognize them and how to negotiate will make the workplace stronger. This session will help you to identify strategic advantages to help you to deal with conflict management in your professional setting. We will explore tools to utilize to resolve conflict. Our goal is to help you to compare your style of conflict and negotiation styles so you can better impact the action plan with better outcomes. Speaker: Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager, Kelly Willenberg & Associates
Get an overview of the definitions and requirements for registration and submission of results requirements to ClinicalTrials.gov. This session will also describe FDA’s role in the compliance and enforcement of ClinicalTrials.gov, as well as a review of available FDA resources for those involved in ClinicalTrials.gov clinical trials. Speakers: Miah Jung, PharmD, Pharmacologist, FDA and Jan Hewett, BSN, JD, Regulatory Counsel (Policy), FDA CDER
The most stressful moment in a site’s research experience just might be the first time you learn that you’ve been selected for an FDA inspection. Panic from not knowing what to expect may hinder an organized and thoughtful approach to preparing for and hosting that inspection. But, what if an institution that has 4-6 inspections every year shared their experiences, and how, in response to those experiences, they now plan and prepare for, host, and manage post-inspection responsibilities? This session will examine just that! This session will demystify the inspection process from a site perspective and give your site a confident and organized plan to manage your first – or next – FDA inspection. Speaker: Neala Lane, MS, CCRC, Associate Director, Quality Improvement Office Indiana University
As the clinical research industry struggles to determine how, or if, to move forward with clinical trials based on the potential hazards related to exposure to COVID-19, the continued protection of the rights, safety, and welfare of participants must still be the primary consideration. However, even without the added safeguards required during this time, the FDA has historically noted that IRBs are not meeting their regulatory obligations and that Sponsors and Clinical Investigators are not assessing their compliance. As Good Clinical Practice is based on shared responsibilities for ensuring credible data from protected subjects, when an IRB is not compliant, neither are the Sponsors and Clinical Investigators. Examine the requirements for a compliant IRB, methods for assessment, and discuss processes to ensure compliance, collaboration, and communication. Speaker: Elizabeth Nelson, President, Regulatory Risk Management, LLC
It is difficult to manage protocol deviations and ensure appropriate corrective and preventive action items are implemented by research sites, and the difficulty increases with the complexity of trial designs. This educational session will present a solution for implementing a CAPA strategy specifically to address protocol deviation management. Sponsor operations teams and clinical research site personnel will benefit from learning practical ways to manage deviations and reduce the risk of further deviations. Speaker: Mindy Ditch, MS, President and Founder, Bloom Clinical Research, LLC
This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. Speakers will employ hands-on activities to create corrective and preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters and 483s. Speakers: Janet Holwell, CCRC, CCRA, TIACR, FACRP, Independent Consultant and Glenda Guest, CCRA, RQAP-GCP, TIACR, President NCRA