Site Management

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2024 Agenda

Sat., Sept 28 8:30 to 9:15                                     Track: Site Management
Strategies for Development, Implementation, and Maintenance of SOPs to Improve Research Operations

Ms. Gauthier and Ms. Salazar will highlight how to maximize the benefits that SOPs bring to both sites and sponsors/CROs while also including real-world examples of how SOPs improve not only research compliance but research operations as a whole. 717

Presenter: Phoebe Gauthier, MA, MPH, Research Scientist, Geisel School of Medicine at Dartmouth College

Presenter: Dagmar Salazar, MS, Manager of Clinical Study Management, The Emmes Company, LLC

Sat., Sept 28 9:20 to 10:05                                   Track: Site Management
Site First Technology - What is it and How to Deploy it Successfully

Ms. Wright will discuss what it really means to be a site first technology. Why a partnership and good communication between all stakeholders is important. 719

Presenter: Keith Wright, MBA, CCRP, Director, Industry Strategy and KOL, Florence Healthcare

Sat., Sept 28 10:50 to 11:35                                 Track: Site Management
The Regulatory Inspection Process: How to Always be Audit Ready

Ms. Noitsis will discuss how to be prepared for a GCP inspection or audit.  Best practices to be implemented including behavior dos and don'ts will be highlighted. 721

Presenter: Flora Noitsis, Hons. BSc, Senior Associate, Quality & Compliance, BioAcuity Consulting, Inc.

Sat., Sept 28 11:40 to 12:25                                 Track: Site Management
Tech Roots at Sites - How a 2023 Change, Changes Everything

Ms. Gregor will discuss why the next wave of tech innovations are owned and controlled by sites, and how to select sites and implement and negotiate reimbursement from sponsors in order to thrive in this new world. 723

Presenter: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare

Sat., Sept 28 1:40 to 2:25                                     Track: Site Management
What's Data Got to Do with It? Data Essentials for the Clinical Research Professional

Ms. Helm will explore the various stages included in a DMP, from study set-up to data collection through data lock, and consider the regulations and guidelines related to good data management practices. Clinical Research Professionals (CRPs) are pivotal to ensuring that study data supports the overall conduct of ethical and scientifically valid clinical research. 725

Presenter: Shirley Helm, MS, CCRP, Senior Adminstrator for Network Capacity & Workforce Strategies, Virginia Commonwealth University

Sat., Sept 28 2:30 to 3:15                                     Track: Site Management
Beyond DCTs: The Future of Modernization in Clinical Trials

The future of clinical trials may be dependent upon more flexible and adaptive technologies that connect sites, sponsors, CROs, and patients in a more meaningful way. Ms. Gregor will focus on what the future will look like with a more integrated technology landscape and the tangible benefits for patients and sites. 727

Presenter: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare

Sat., Sept 28 3:45 to 4:30                                     Track: Site Management
Break the Blind Escape Room Adventure

Ms. Flynn will discuss partial and full un-blinding in clinical trials. The talk will be followed by a hands on "escape room" activity where participants attempt to unblind a trial with only the clues provided. 729

Presenter: Gayle Flynn, BA, ALM, Senior Director, Cognizant

Sat., Sept 28 4:35 to 5:20                                     Track: Site Management
An Overview of Clinical Research Pharmacy

Dr. Brzozowski will introduce research pharmacy and its role in clinical research. We will also detail how research pharmacy is integrated with clinical research operations in ensuring patient safety and regulatory compliance. Finally, we will provide insights into the challenges and opportunities for working closely with the research pharmacy team. 731

Presenter: Dominic Brzozowski, PharmD, MBA, Clinical Research Pharmacist, Yale New Haven Hospital