Breakout Session III

Increasing Demographic Diversity in Your Clinical Trial Population
A Good Site Should Not Be Hard to Find: How to Stand Out in Site Selection
Digging Deep: Identifying Study Opportunities Beyond the Traditional Pharmaceutical Arena
ICH Update: Vendor Oversight & RBM
Positioning Your Site for Acquisition
How Real-World Evidence Can Monetize Your EMR Data
Get the Most Out of Patient Pre-screening
Engaging Patients to Improve Your R&R
Take it to the Patient: Understanding Tele-Medicine & Remote Visits
Investigator-Initiated Trials: Turning Physicians’ Ideas into New Revenue Streams
Optimize Your Study Budget
Who’s Liable for What?
Make the Most of Your CTMS System

Topics are subject to change.

Learning LabSM
Increasing Demographic Diversity in Your Clinical Trial Population
The importance of recruiting diverse patient populations has been highlighted by regulators, sponsors and sites alike. In response, SCRS developed the Diversity Awareness Program through which a diversity survey was conducted and an Assessment Tool that helps sites improve diversity recruitment was created. This session will explore the relationship between the research paper and the Assessment Tool and discuss practical implementation of the Assessment Tool for sites.

Attendees will:

  • Identify steps taken to increase the recruitment of diverse patient populations in clinical trials by regulators, sponsors and sites;

  • Disseminate the results of the SCRS diversity research paper to boost site success in recruiting diverse patient populations;

  • Explore how the Assessment Tool can be implemented by sites to increase the recruitment of diverse patient populations.

Diana Foster, PhD
Vice President, Strategy & Development, SCRS

Anne Marie Inglis
Head, US Clinical Operations, GlaxoSmithKline

Scott Gray
CEO, Clincierge

Joseph Grosso
Clinical Development Consultant, Lilly

Site MattersSM
A Good Site Should Not Be Hard to Find:
How to Stand Out in Site Selection
What are sponsors and CROs really looking for when they select sites for studies, and how can you position your site for study selection success? Sponsors and CROs will share what key metrics they look for when selecting sites, and how sites build positive relationships with them to enhance site and study outcomes.

Attendees will:

  • Understand how to formulate key metrics related to site selection and positive study outcomes;

  • Understand how to work with sponsors and CROs during studies to build these metrics;

  • Understand how to use metrics to create positive relationships with sponsors and CROs.

Ben Daniel
Director, Business Development, goBalto

Jessica W. King, CCRA
Senior Manager, Site Partnerships, Oncology Division, Covance

Katie Gaiek
Director, Business Development, Bio-Optronics

Sheila Marsh, MPH
Project Lead/Senior Clinical Research Associate, GlaxoSmithKline
Digging Deep: Identifying Study Opportunities Beyond the Traditional Pharmaceutical Arena
Learn the creative ways sites are identifying studies outside of the mainstream and dig into a deep well of opportunity. Discover the risks and rewards of engaging small biotech and other companies beyond the traditional pharmaceutical industry.

Attendees will:

  • Learn about product development beyond top pharma companies;

  • Learn how to identify small and non-traditional companies with research opportunities appropriate for your site;

  • Learn how to approach and engage these companies for successful study acquisition.

Nancy Fuller, PMP, MSHR
Director of Customer Engagement, Shared Investigator Platform, Cognizant

Susan V. Walsh
Vice President, Sales & Strategy, Total Clinical Trial Management

Lindsay Vaughn
Director of Business Development, Medical Research South

Chris Hoyle, MBA
Executive Director, Elite Research Network
ICH Update: Vendor Oversight and RBM
Revisions to ICH (E6) GCP guidelines have introduced changes to vendor oversight. Become familiar with how these changes impact sponsors, CROs and professional service providers what this means for your site.

Attendees will:

  • Learn what ICH (E6) is and how it has changed;

  • Understand how these changes impact sponsors and CROs, and what this means for sites;
  • .
  • Understand how to apply the related guidelines to your site.

Rick Arlow
Founder & CEO, Complion

Dan O'Connell
Director, Strategic Monitoring, Medidata Solutions

Melissa Poindexter, RN, BSN
President, Advances In Health

David Vulcano, LCSW, MBA, CIP, RAC
Vice President, Clinical Research, HCA Healthcare
Positioning Your Site for Acquisition
Packaging your site for sale means viewing it as a business with a proven track record of success and the potential for significant growth. In this session we will discuss how to make your site attractive to potential buyers, and what documentation and processes are necessary to sell your site.

Attendees will:

  • Learn how to determine whether your site is ready for acquisition;

  • Learn about the documents necessary to sell your site;

  • Learn what buyers are looking for in site purchases;

  • Learn how to value your site for optimal return.

Steve Clemons
Vice President, Clinical Operations/Founder, VitaLink Research

Mitchell Parrish
Vice President, Legal & Regulatory Affairs, Kinetiq

Nolan Kapp
Managing Director, Allston Advisory Group

David Blume
Managing Director, Edgemont Capital Partners
How Real-World Evidence Can Monetize Your EMR Data
Real-world evidence has demonstrated the value of your EMR data. Learn how the market for EMR data works, how your patients’ privacy is protected, and how you can enter this market to gain an additional revenue stream for your site.

Attendees will:

  • Learn how the market for EMR data works;

  • Learn how data is aggregated and patient privacy is protected;

  • Learn how your site can add revenue by selling de-identified, aggregated data.

Brian Bromberek
Vice President for Clinical Operations, Cardiovascular Research Consortium

Kari Venn
President, Research, LMC Manna Research

Rodger Pinto, PhD
Executive Vice President, GEMMS

Paul Mitchel
Vice President, Global Business Strategies, iPatient Axis
Get the Most Out of Patient Pre-screening
Effective pre-screening strategies can increase study enrollment while decreasing time and effort spent searching for study patients. In this session, sites will discuss their most effective methods for implementing pre-screening strategies for individual and multiple enrolling studies. Attendees will hear how sites have successfully incorporated pre-screening assistance from recruitment agencies to complement their own system.

Attendees will:

  • Learn what are and are not effective pre-screening techniques;

  • Learn how to implement your own pre-screening program;

  • Learn how to engage pre-screening companies in a two-way conversation to improve effectiveness.

Sam Haiden
Executive Director of Strategic Partnerships, StudyKik

Lisa Bjornestad
Director, Site Alliance, the Americas, PAREXEL

Mohammad Millwala
CEO, DM Clinical Research

Ryan Haynes, MT (ASCP)
Director, Clinical Research, CSSi
Engaging Patients to Improve Your R&R
Your current patients are the most powerful focus group you have on your site’s recruitment and retention effectiveness. Are you asking them for feedback? In this session, learn how to use patient surveys as a powerful tool to build your business.

Attendees will:

  • Learn how to set up and implement surveys and understand regulatory implications;

  • Learn how to use surveys to give real-time feedback on study design and implementation to sponsors and CROs;

  • Learn how to use surveys to improve practices at your site.

Megan McBride, MPH
Clinical Innovation Leader, Janssen

Marisa Rackley
Head of Patient & Site Centricity, Vertex

Melynda Geurts
Senior Vice President, Site & Patient Engagement, Total Clinical Trial Management

David Marquez
Research Director, Clinical Trials of Florida
Take it to The Patient: Understanding Tele-Medicine & Remote Visits
Tele-medicine and remote study visits can ease the burden on patients and can be conducted via a variety of methods. Join this session to discuss sub-contracted home visit agencies, tele-medicine and more.

Attendees will:

  • Learn about the current regulatory issues around remote visits;

  • Learn about budgeting and payments for remote visits;

  • Learn about different types of remote visits and the benefits and struggles encountered with each.

Clare Grace, PhD
Vice President, Site & Patient Access, Syneos Health

Robin Douglas
Head of Operations for Virtual Trials, IQVIA

Janusz Kabata, MD, PhD, MBA
CEO, GP4research

Hassan Kadhim
Senior Associate Director, Head of IT Clinical Trial Planning & Management, Boehringer Ingelheim
Investigator-Initiated Trials: Turning Physicians' Ideas into New Revenue Streams
With an annual sponsor spend of almost $2 billion on IITs, the wealth of study opportunities is endless. However, this introduces challenges like securing funding, creating budgets, and protecting your IP. Attend this session to learn how to turn physician’s ideas into a new revenue stream for your site and how to successfully implement IITs.

Attendees will:

  • Learn the difference between Sponsor-Initiated Trials and Investigator-Initiated Trials;

  • Learn the inherent challenges and considerations for IITs;

  • Learn how to support your physicians as they implement IITs.

Nathan Laney, MD
Regional Medical Scientist, Novo Nordisk

Len Jokubaitis, MD
Clin Ops Head, Americas MAO, Janssen

Claudia Gomes, MS, CCRC
Director, Clinical Research & Scientifice Intelligence, Envision Physician Services

Margie Pazzi, BSN, RN, CCRP
Clinical Research Director/HIPAA Officer, Center for Neurosciences

Site SolvingSM
Optimize Your Study Budget
Sites often feel left in the dark about how sponsors and CROs build out their study budgets. Your site’s fees shouldn’t be a mystery, so take charge! Learn how to organize and document your site’s costs to optimize your study budgets.

Attendees will:

  • Learn how to determine and document your site's fees;

  • Learn about standard-of-care and fair market value pricing;

  • Learn about tools available for budgeting and determining costs.

Michael Bonavilla
Director, Business Development, Bio-Optronics

Matt Lowery
Director, CRBD+

Ana Marquez
CEO, Clinical Site Partners
Who's Liable for What?
Most site contract negotiators aren’t attorneys. With an ever-increasing number of vendors involved in studies and the introduction of innovative study designs, the risks are becoming more complex. Join this session to learn when your site can benefit from working with an attorney, best practices for contract management and more.

Attendees will:

  • Learn why and when sites should consult an attorney;

  • Learn how to identify contractual needs to protect your site;

  • Discuss best site practices utilized to protect your site.

Michael Griffith
Managing Director, Intend Research
Making the Most of Your CTMS System
Whether your site already uses a clinical trial management system or not, a CTMS can improve site operations. Join this discussion to determine whether using a CTMS would benefit your site, evaluate the success of your CTMS utilization if you’re already using one, and discuss use cases demonstrating how sites make the most of their CTMS system.

Attendees will:

  • Learn about the functionality present in CTMS products;

  • Learn how a CTMS supports site operations;

  • Learn specific cases of how a CTMS has been used to support a clinical study at a site.

Kelly Smith
Solutions Consultant, Bio-Optronics

Leisel Koeber
Senior Vice President of Operations, Clinical Trials of Texas

Location: See Program for Room Location Date: October 13, 2018 Time: 4:30 pm - 5:30 pm