Advanced Management

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2023 Agenda

Saturday, September 30, 2023 at 8:30 to 9:15                                                                                                        Track: Advanced Management

Managing Multisite Investigator-Initiated Trials – What you Need to Know

The expertise necessary to successfully manage multisite investigator-initiated trials (IITs) requires proficient managerial skills, comprehension of investigator and sponsor responsibilities, and exceptional professional competence. Dr. Statler will outline the fundamentals of multisite IIT management, explicitly focusing on sponsor responsibilities and external site quality control. 217

Presenter: Dr. Abby Statler, PhD, MPH, MA, CCRP,  Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center 

Saturday, September 30, 2023 at 9:20 to 10:05                                                                                                    Track: Advanced Management

Resource Management and Capacity Planning for Clinical Trials

This talk will discuss resource management and capacity planning principles used in examining the workload in a research coordinator pool at an academic research center. The aim is to improve clinical research leaders’ ability to make informed decisions to increase operational efficiency and ensure workloads are adequately resourced.219

Presenter: Kesley Tyson, DHA, MS, CCRP, Director, Clinical Trials Office & Research Operations, Morehouse School of Medicine

Saturday, September 30, 2023 at 10:50 to 11:35                                                                                      Track: Advanced Management

Adaptive Design Trials: Logistical Considerations for Clinical Operations

Adaptive design studies are often considered more complex to execute than traditional studies. This presentation will provide an overview of the different types of adaptive trials that are usually accepted by regulators and delves into logistical/operational challenges encountered during their implementation, including solutions to overcome such challenges. 221

Presenter: Vatche Bartekian, BSc, MSc, President, Vantage BioTrials, Inc.

Saturday, September 30, 2023 at  11:40 to 12:25                                                                            Track: Advanced Management

Challenges Conducting Multi-Center Trials at Satellite Sites

This session focuses on how to mitigate common challenges such as clinical investigator oversight (and what language should be included in Standard Operating Procedures), operationalization of studies at multiple sites, and associated financial concerns. This discussion will help sites prepare for successful clinical trial implementation. 223

Presenter: Jo Ann Elrod, PhD, CCRP

Saturday, September 30, 2023 at 1:40 to 2:25                                                                                  Track: Advanced Management

Feasibility Surveys - How to Make them Feasible for Your Site

Feasibility surveys represent an important tool for sites and sponsors/CRO's to collect information about each other, but best methods haven't kept up with the changing landscape of clinical research. Understanding why and how sponsors use these surveys allows sites to identify best practices for managing this step of site selection. This talk will provide background, regulatory considerations, and several actionable takeaways to consider, including T&E, tech solutions, creating standardized documents, and implementing master agreements. . 225

Presenter: Betsy Wagner, BS, MPH, CRC, Director, IQVIA

Saturday, September 30, 2023 at 2:30 to 3:15                                                                                          Track: Advanced Management

Implementing Clinical Research Onboarding and Educational Programs at an Academic Medical Center

Ms. Wentzel will provide attendees with an overview of how a large pediatric academic medical center established a formalized onboarding program as well as a clinical research competency series for clinical research professionals. 227

Presenter: Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara