2021 Full Program Replay

Jan 12, 2021 ‐ Sep 30, 2021



Products

Protocol Feasibility to Improve Site Operations and Achieve Study Goals

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Protocol Feasibility to Improve Site Operations and Achieve Study Goals

May 13, 2021 12:15pm ‐ May 13, 2021 1:30pm

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(s):
  • Wendy Tate, PhD, GStat, Director, Research Operations, Advarra

techXpo Session: Exit the Feature Battle: How to Think Long Term and Prepare Your Site for the Future of Technology in Clinical Research

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techXpo Session: Exit the Feature Battle: How to Think Long Term and Prepare Your Site for the Future of Technology in Clinical Research

May 13, 2021 1:30pm ‐ May 13, 2021 2:30pm

For years, you’ve been adding the latest and greatest technology to help you be more efficient at running clinical trial operations, checking all the feature boxes. But at some point - it became overwhelming to manage all the logins, integrations, and updates. In this session, we’ll review all of the key qualities sites need to look for in their technology partners in addition to features alone. We’ll also walk you through how sites can decrease the number of systems they manage yet increase their connectivity within the clinical trial ecosystem with sponsors and patients

NOTE: This session does NOT offer ACRP Contact Hours.

Speaker(s):
  • Bree Burks, RN, CCRP, BSN, MSN, Vice President of Strategy, Site Solutions, Veeva Systems

Remote Monitoring Strategies

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Remote Monitoring Strategies

May 13, 2021 2:45pm ‐ May 13, 2021 3:50pm

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

Speaker(s):

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

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

May 20, 2021 10:00am ‐ May 20, 2021 11:00am

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(s):
  • Ken Getz, MBA, Director of Sponsored Programs, Associate Professor, CSDD, Tufts University

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

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

May 20, 2021 11:00am ‐ May 20, 2021 12:00pm

Decentralized clinical trials (DCT’s) 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.

Speaker(s):

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

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

May 20, 2021 12:15pm ‐ May 20, 2021 1:30pm

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(s):
  • Steve Pope, MSHS, CCRP, Senior CRA, PRA Health Sciences

techXpo Session -- Quality Improvements as a Result of Paperless Site-Based Systems

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techXpo Session -- Quality Improvements as a Result of Paperless Site-Based Systems

May 20, 2021 1:30pm ‐ May 20, 2021 2:30pm

Paperless sites and site networks are driving quality and improved timelines for the clinical research industry.

NOTE: This session does NOT offer ACRP Contact Hours.

Speaker(s):
  • Rick Greenfield, BBA-IS, CEO, RealTime Clinical Trial Management Systems
  • Nathan Levens, Director of Virtual Solutions & Technology, RealTime Clinical Trial Management Systems

Rethinking Clinical Trials for the Future

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Rethinking Clinical Trials for the Future

May 20, 2021 2:45pm ‐ May 20, 2021 3:50pm

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(s):

Keynote: The Future of Decentralized Clinical Trial Development

Preview Available

Keynote: The Future of Decentralized Clinical Trial Development

May 27, 2021 10:00am ‐ May 27, 2021 11:00am

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.

Speaker(s):
  • Patrick Floody, Senior Director, Global Study Strategy & Optimization, Regeneron

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

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

May 27, 2021 11:00am ‐ May 27, 2021 12:00pm

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(s):
  • Lisa Haney, BS, CCRC, Senior Clinical Quality Specialist, Medtronic