The Association of Clinical Research Professionals

Virtual ACRP 2020, Part I – Study Management & Conduct (Part 2) Track Replay

This package is a replay of the ACRP 2020 Virtual, Part Program.  It includes the following sessions:

  • The Two Most Important R’s in Research: Recruitment and Retention from a Site’s Perspective

The recruitment and retention of study participants is central to a successful clinical trial. Yet these basic requirements remain challenges within and across study sites. Unmet goals increase costs, deplete resources, and prolong the time to market. Lost to follow up subjects compromise the power of results and can result in missed signals. Why is this central element also one of the most difficult to execute? There are numerous challenges to recruiting patients to and keeping them in trials. While sites might not have much control over many of these, we certainly do when it comes to the tools used to recruit and engage patients at the local and site level. Takeaways: Techniques for improved enrollment planning, ideas and tools for more effective patient recruitment tactics, and strategies for retention. Speaker: Gwen Jacobs, CCRC, MS, RN, Senior Clinical Research Nurse, Uptown Research Institute

  • Risk Management in Clinical Trials Project

Risk management is an ongoing process that continues through the life of a project. It includes processes for risk management planning, identification, analysis, monitoring, and control. Many of these processes are updated throughout the project lifecycle as new risks can be identified at any time. It’s the objective of risk management to decrease the probability and impact of events adverse to the project. On the other hand, any event that could have a positive impact should be exploited. Speaker: Walaaeldin Ahmed, PMP, PBA-PMI, RMP-PMI, BCMAS, CCPM, CM, APDPHR, Managing Director, KAUMED Clinical Research Organization

  • Using Data Analytics in Quality Processes

Clinical Quality Assurance can benefit from the use of advanced analytics. These can enable faster and holistic detection of quality issues through the use of descriptive and predictive analytics, ensure efficient use of QA resources, and aid resolution of quality issues. Learn applications of analytics in quality processes, including an overview of data analytics concepts, basic data analytics techniques, how to develop simple analytics using common software, such as EXCEL. Gain insight into how analytics may be applied throughout the development lifecycle of a molecule and learn how analytics may be used in the planning and conduct of audits. Speaker: Richard Bowling, Team Lead, Quality Data Operations, Genentech

  • Safety Reporting Reference Model: Optimizing

Driven by ethical obligations to protect patients and pressure to conduct trials more cost effectively, while also adhering to regulatory requirements, pharmaceutical companies and CROs are using more innovative approaches to distribute safety reports to investigators, ethics committees and regulatory authorities worldwide. In this presentation, we will describe a process by which a sponsor or CRO can examine their global safety distribution and move towards a harmonized business model with the right safety information being distributed to the right person at the right time using the latest rules-based, workflow technologies. We will suggest an operational model that enables safety distribution and receipt to be performed more efficiently at Sponsor, CRO, Site, and Ethics Committees. Speaker: Steven Beales, SVP, Scientific and Regulatory, WCG

Purchase Track Replay

This program is a compilation of recorded sessions from Virtual ACRP 2020, Part I.