The Association of Clinical Research Professionals

Virtual ACRP 2021 Operational Efficiencies Track Replay

This package is a replay of the ACRP 2021 Virtual Program.  It includes the following sessions:

  • Working together for Study Success: Sponsors, Sites, & Technology Companies

    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

  • Protocol Feasibility to Improve Site Operations and Achieve Study Goals

    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

  • Remote Monitoring Strategies

    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

  • The Evolving State of Clinical Trial Execution: Pilot or Permanent?

    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

  • The Future is Now: Discussions on Decentralized Clinical Trials, Diversity, and Inclusion

    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

  • Data Quality Made Easy: A Guide for CRAs and Study Coordinators

    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

  • Rethinking Clinical Trials for the Future

    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 Future of Decentralized Clinical Trial Development

    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

  • CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls

    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

  • Trends as a Means to an End: A Case Study in Process Improvement

    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

  • Truly Integrating Research Administration – Best Practices

    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

Purchase Track Replay

This program is a compilation of recorded sessions from Virtual ACRP 2021.