Breakout Session II

Breakout Session Options:

  • Increased Pressure on PIs: How DCTs Impact Oversight
  • Understanding the True Cost of Clinical Technology
  • Utilizing Technology to Increase Diversity & Expand Recruitment
  • Training Challenges in the Age of Decentralized Trials


Increased Pressure on PIs: How DCTs Impact Oversight
The rise of decentralized clinical trials (DCTs) is only making oversight of PIs more critical. As trial operations spread and become more remote, the role of the PI as a center of gravity becomes increasingly vital. With new FDA guidance outlining the expectations placed on PIs, it is important to understand how to demonstrate and document oversight, especially when patients are remote.

Vivienne van de Walle, MD, PhD,

Roman Fishchuk, MD, MSc,
CEO, Clinical Trials Unit, Central City Clinical Hospital of Ivano-Frankivsk City Council
Margarita Nunez, MD,
Principal Investigator, Synexus/AES
Erin Stackowitz, US Innovation Lead, Sanofi


Understanding the True Cost of Clinical Technology
Sites now face the daunting task of needing to manage ever-increasing amounts of technology. But what is the true cost of a new technology required for a trial? Join our panel as we discuss what sites need to know to effectively budget for technology management and ensure their budgets accurately reflect their needs.

Deena Bernstein, MHS,
Vice President, Customer Success, Datacubed Health 

Jennifer Hunter, , CCRP, BAAS,
Director of Research Operations, Mary Crowley Cancer Research
Conor Kane, MBA, B.Eng,
Senior Director, Janssen Clinical Innovation, Janssen R&D
Kristin Surdam, MS, PMP, CCRC,
Sr. Director, KOL & Strategy, Florence Healthcare


Utilizing Technology to Increase Diversity & Expand Recruitment
The traditional brick-and-mortar clinical trial paradigm has long confined the access to patients living within a 50-mile radius of a clinical trial site. As decentralized clinical trials have accelerated significantly in the past few years, we have seen their many benefits and opportunities for growth. How can we utilize technology to improve diversity, equity, and access for trial participants? This exciting panel will discuss how technology can provide your site with a leg up in diverse population trial recruitment and what technology can do to enable diverse community engagement.

Diana Foster, PhD,
CEO, Total Diversity

Angel Akinbinu,
Director, Site & Patient Diversity, Syneos Health
Garo Kiledjian, COO & Founder/CEO, Trialogic & SGM Alliance
Alan Lane,
Sr. Director, Strategic Accounts, OneStudy Team
Stephen Rouse,
Senior Director of Partnerships, Triomics


Training Challenges in the Age of Decentralized Trials
When executed well, decentralized clinical trial (DCT) design could both reduce resource consumption and accelerate treatment arrival to the patients that need them. But to realize the benefits of a DCT, it’s important to understand that it comes with additional education and training needs. Training remains a challenge in trials, and decentralized elements can add additional demand on sites. This dynamic panel will discuss how we can structure training to be more effective for decentralization and what training needs to look like as we implement new technologies.

Karen McIntyre, MSc, Clinical Trials,
Vice President, Global Site Alliances, Parexel

Melissa Holbrook, MSN,
Executive Vice President, Operations, Velocity Clinical Research
Sean Jensen, Director, Site Relationship Management, Merck
James Riddle, MCSE, CIP, CPIA, CRQM,
VP Research Services & Strategic Consulting, Advarra


Location: See App for Room Location Date: June 7, 2023 Time: 2:00 pm - 3:00 pm