- Operations

Breakout Sessions I
April 29, 2021 • 0 Comment

Staff Retention Strategies for a New Era

*Human Resources
In an increasingly competitive workforce, site employees are looking for additional benefits beyond just financial. Learn how your site can retain and engage talent for the long run.

FACILITATOR 
Amanda Wright, Co-Founder and Chief of Site Operations, Javara

PANELISTS 
Anne-Marie Baughn, RN, MSN, Director, Business Development, RxTrials
Bree Burks, RN, MSN, VP of Strategy, Veeva
Wilfredo De Jesus-Monge, MD, MSc, Founder, clinicaLea
Garo Kiledjian, Founder & CEO, SGM Alliance/Trialogic
 

 

How & Why to Set Up a Regulatory Team

*Regulatory
Does your site need a regulatory department? Understand when your site may need a regulatory department and the evolution of regulatory needs. This session will help you formulate a training program for your site’s regulatory team and effectively manage the transfer of knowledge between a central office and local site operations.

FACILITATOR 
Sarah Attwood, Director, Client Services, Castle IRB and Clinical Biosafety Services

PANELISTS 
Jamie Lynn Bhairoo, RN, CCRP, CEO/Business Development & Budget Negotiations, Cedar Crosse Research Center
James Riddle, MCSE, CIP, CPIA, VP, Research Services and Strategic Consulting, Advarra
Kathy Stoddard, RN, CCRC, Executive Vice President, Velocity Clinical Research
 

 

Contracts & Clauses: What They Really Mean

*Legal
In this session, you’ll get the ABCs and 123s of contracts. You don’t need to have a legal degree to understand a contract and its clauses, but you do need to have the tools and insights to know how to identify the major components of a CTA and how to fulfill contractual obligations. Get all you need to know in this session.

FACILITATOR 
Kristin Surdam, MS, PMP, Sr. Director, KOL & Strategy, Florence Healthcare

PANELISTS 
Chuck DeMars, Corporate Director of Budgeting and Contracting, CenExel
Zachariah Evangelista, Partner, Ser & Associates, PLLC
Viktoria Jones, Manager, SSU Legal Contracts- Global Site Contracts, Syneos Health
 

 

The First Frontier: Explore Entry Into Phase 1 Trials

*Operations
There are tremendous nuances with phase 1 clinical trials. This session will explore the foundational understanding for breaking into phase 1 clinical trials. Learn how to maintain quality throughout the implementation and execution process and set your site up for success.

FACILITATOR 
Dawn Overcash, Director, Strategic Site Collaborations, PPD, part of Thermo Fisher Scientific

PANELISTS 
Darin Sims, Managing Member, Pinnacle Research Group
Anupama Walia, Senior Country Operations Leader, Genentech/Roche
Gwen Welty, Executive Director, Early Phase Services, Centricity Research
 

 

Enabling a Low-Burden DCT Experience: Wins & Losses

*Operations
How can we lessen the burden of decentralized clinical trials (DCTs) on sites and patients? This session will discuss and analyze what we’ve learned from using DCTs over the past several years. Understand how DCT elements affect our patients and determine which DCT tools may be easiest to implement and manage at your site.

FACILITATOR 
Steve Satek, MBA, Chief Commercial Officer, Flourish Research

PANELISTS 
Karin Beckstrom, Director, eCOA Products, Clario
Leslie Clapp, MD, VP, Medical Operations, Avacare
Kelly Sanford, MS, Head of Operations, Site Enablement Solutions and Decentralized Trials, IQVIA
 

 

I’ve Tried It All! Recruitment Struggles & Modern Solutions

*Recruitment & Retention
When it seems like you have tried everything with recruitment, what do you do next? How do you address challenges with recruitment in modern times with modern solutions? Learn best practices, trends and innovative ideas for recruitment from sites and industry partners.

FACILITATOR 
Nadege Gunn, MD, CPI, Medical Director, Impact Research Institute

PANELISTS 
Steven Geller, MD, FACP, Medical Director, Centennial Medical Group
Debra Rogge, RN, BSN, MSA, Director, Biopharma Site Management and Monitoring, AstraZeneca
Walter Storm, Co-Founder, Digital Alchemist, Aspen Insights
 

 

Study Budgets: Back to Basics

*Finance
It’s not about building a better mousetrap, but it is about knowing how to build a better study budget. Join this breakout to understand the costs related to clinical trials and learn how to invoice for your study-related activities. Leave with supporting forms and templates that will strengthen your budget negotiations and your bottom line.

FACILITATOR 
Brian Hunter, VP of Contracts & Trial Management CNS Healthcare

PANELISTS 
Jami Hasbrouck, Manager, Site Contracts, Syneos Health
Amy Wooten, Director, Accelerated Enrollment Solutions (AES)
Lori Rich, VP of Financial Operations, Elligo
 

 

Survival of the Fittest: Strategizing Business Development

*BD & Relationships
This session will discuss innovative methods to revolutionize your business practices. Learn how to succeed in creating a successful site that will have you choosing which studies to take. Understand how to utilize collaboration and understand the dynamics that get you picked for that study!

FACILITATOR 
Kerry Gorman, Senior Director, Strategic Site Solutions, IQVIA

PANELISTS 
Mazhar Jaffry, MBA, MHA, MBBS, President/CEO, Revival Research Institute
Jason Palasota, President, Clinitiative Health Research
Michael Rosenblatt, VP, Product Development, Genentech
Matt Smith, Vice President, Research Site Development, Slope

 

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Breakout Sessions II
April 29, 2021 • 0 Comment

Demystifying the Onboarding Experience

*Human Resources
Your site’s staff onboarding process can make or break a new employee’s success. Identify what types of trainings are needed and when, as well as programs and processes sites have used to successfully onboard staff. Discover strategies to help your new employees work independently as quickly as possible.

FACILITATOR 
Karen McIntyre, MSc, VP, Global Site Alliances, Parexel

PANELISTS 
Sonia Brodie, MSc, CCRP, VP, Clinical Research, Centre for Neurology Studies
Michele Cameron, BSN, MBA, CCRC, Director of Clinical Research, Clearwater Cardiovascular Consultants
Charmagne Crescini, MA, Clinical Trial Site Experience Lead, Pfizer
Wanda Vinson, Principal Learning Specialist, AES
 

 

FDA Inspections: How to Prepare

*Regulatory
Are you certain your site is ready for an FDA inspection? This session will include insights from FDA inspectors and sites that have been inspected. Learn what measures they have implemented to ensure you are inspection ready.

FACILITATOR 
Ana Marquez, MSF, CEO, Clinical Site Partners, A Flourish Research Site

PANELISTS 
Belinda Gardner, Vice President, US Site Operations, Pfizer
Sandy Hirscher, Country Clinical Quality Management Lead, Merck
Jeanette Poehler, CCRC ACRP, PM, Director of Clinical Research, Moradi
Sandeep Vaid, MD, Owner, Medical Director, PI, Vista Clinical Research

 

 
Enabling Patients: Best Practices for Ensuring Patients Participate

*Recruitment
Join us to hear proven best practices to take patients from initial interest to trial enrollment. This session will explore modern stipend practices, patient engagement strategies, and how to align your site’s processes to increase trial awareness and participation.

FACILITATOR 
Vivienne van de Walle, MD, PhD, CPI, CMO, Owner & PI, PT&R

PANELISTS 
Hera Arham, MBA, MA, Executive Director, Marketing & Patient Engagement, DM Clinical Research
Samantha Botts, Global Patient Recruitment and Retention Lead, Sanofi
Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime Software Solutions

 

 
How to Build Strong Relationships of Trust

*BD & Relations
Join this panel discussion on how to build strong industry relationships and explore the communication fundamentals. Learn how to develop genuine rapport with contacts for reciprocal alliances.

FACILITATOR 
Casey Orvin, Chief Commercial Officer, CenExel

PANELISTS 
Sean Cunningham, MBA, Study Site Engagement Team Lead, Clinical Study Start-up & Engagement, Takeda Pharmaceutical Company Limited
Shruti Iyer, Principal Innovation Architect, Clinical Innovation, Oracle Life Sciences
Jason Roth, Chief Business Officer, Tekton Research

 

 
Site Director Toolkit: Creating Resources to Run a Successful Site

*Operations
What do you need in your toolkit to be a successful and long-term site director? This session will help you interpret gaps in your operations, how to fill those gaps, and tools to deploy at your site to ensure long-term success. Learn how to integrate strong business practices into your site to ensure accountability and profitability.

FACILITATOR 
Karri Venn, RD, CCRC, COO, Centricity Research

PANELISTS 
Mehwish Buksh, Regional Director, IMA Clinical Research
Roman Fishchuk, MD, MSc, CEO, Central city clinical hospital of Ivano-Frankivsk City Council
Amy Jenkins, MSN, ACNP, Senior Director, Clinical Research Optimization, Lilly
Ram Yalamanchili, CEO, Tilda Research

 

 
Tactics to Improve On-Time Payments

*Finance
Many sites only have three months or less of operating cash. This session will discuss the hurdles that impact delayed payment terms and recognize the downstream implications that can make or break a site’s success. Learn how to improve on-time payments and who is responsible for what in the payment process.

FACILITATOR 
Justin Vega, Sales Engineer, Greenphire

PANELISTS 
Kathy Cox, MS, President, Interspond, LLC
Mickey Johnson, Executive Director, Syneos Health
Carlos E. Orantes, Chief Executive Officer, Alcanza Clinical Research
Lucia Rodriguez, MS, Director of Research, Evolve Clinical Research

 

 
Uncovering the Hidden Costs of Hybrid Trials & DCTs

*Finance
Join us as experts in the field identify all the different costs associated with hybrid decentralized trials. Understand how hidden costs are affecting your site’s bottom line and how to justify additional budget line items to ensure your costs are covered.

FACILITATOR 
Meghan Harrington, MS, VP, Clinical Trial Financial Management, Medidata

PANELISTS 
Mary Costello, Head of Site and Investigator Network, Medable
Janusz Kabata, MD, PhD, MBA, Founder & CEO, GP4research
Lindsay McIntire, LPN, CCRC, Director, RWE Clinical Trials Project Management, Walgreens
 

 
Diverse Patient Recruitment & Engagement

*Diversity
This case study review of diversity in action will feature a panel discussing examples of success and learnings for patient recruitment and engagement. Review recent case studies as speakers share best practices and pitfalls to avoid for study recruitment.

FACILITATOR 
Fabian Sandoval, MD, President & CEO, Emerson Clinical Research Institute

PANELISTS 
Faaiz Hussain, Founder, Digital Auxillus
Sandy Orzel, Sr. Director of Operations, Neighborhood Healthcare
Peter Fronte, MBA, President & CEO, Altura
Ashley Moultrie, Director, DEI & Community Engagement, Javara
Nicole Stiff, ACRP-CP, Corporate Operations & Business Development Manager, Revival Research Institute
James Schultz, MD, Chief Medical Officer, Neighborhood Health
 

 

The Record Retention Burden: Balancing Regulations & Your Agreements

*Legal
Post-study record retention is more challenging for sites than ever before. The expertise needed for today’s record archiving now includes more sophistication in inventory management, electronic document security and preparation for medium degradation and technology obsolescence. Additionally, sites are now seeing increased requirements for record retention from sponsors and CROs. Join us for a session that will explore what the actual regulations for record retention are, what is required to be a long-term record storage vendor and how to set mutually beneficial agreements with sponsors and CROs.

FACILITATOR 
David Vulcano, LCSW, MBA, CIP, RAC, Honorary President, SCRS, Vice President, Clinical Compliance & Integrity, HCA Healthcare

PANELISTS 
Mara Di Mattia Twing, CCRC, ACRP PM, Director of Clinical Research, Integrative Research Associates (IMA)
William Dirkes Jr., MD, MBA, Founder & CEO, docutrial
Christine Scheuring, MPH, Director of Quality and Compliance, EmVenio

 

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Breakout Sessions III
April 29, 2021 • 0 Comment

Growing Your Workforce: Where Will My Next Coordinator Come From?

*Human Resources
Sites need to get creative when looking for their next team member. In this session we’ll share traditional and non-traditional ways to find site staff as well as the skill sets needed to excel in clinical research.

FACILITATOR 
Susan Landis, Executive Director, ACRP

PANELISTS 
Lynn King, MHA, Chief Operating Officer, M3 Wake Research
Dana Poff, Executive Vice President, IMA Clinical Research
Lauren Stockwell, Director of Outreach & Engagement, Clinical Research Fastrack

 

 

The New Regulatory Guidelines Landscape

*Regulatory
What new regulatory guidelines should sites be prepared for? Understand recent laws and regulations that will impact your site operations, including regulatory guidelines for new technology, Medicaid, and diverse patient enrollment in your clinical trials.

FACILITATOR 
Jennifer Hunter, CCRP, BAAS, Director of Research Operations, Mary Crowley Cancer Research

PANELISTS 
Marcy Kravel, MBA, Head of Oncology Strategy, Inato
Michael Koren, MD, CEO, Jacksonville Center for Clinical Research
Marc Wartenberger, Director, Security Corporate Qa & Compliance, CRIO

 

 

Maximizing Efficiency with Site Technology Training

*Operations
Training is integral to the implementation of any new technology, but how much is too much? What types of training should we keep, stop, or continue? This panel will discuss changes that need to be made regarding how sites are trained for trials as well as which types of training are actually needed. Hear sites discuss what types of training have benefited them and discuss solutions for streamlining training needs.

FACILITATOR
Jean-Marc Tellier, MSc, MBA, Clinical Research-Global Innovation Lead, Sanofi

PANELISTS
Lestter Cruz Serano, MD, BCMAS, Head of Medical Affairs and Global Site Engagement Lead, Cognizant Technology Solutions
Nicholas Focil, MBA, CEO, Format Medical Research
Kate Yawman, MBA, Director, Product Management, Advarra

 

 
Winds of Change: Finding the Investigator of the Future

*Human Resources
How do we find and train new investigators? Where do we find quality providers to be part of clinical research? This session will explore how to recruit outside of the clinical research industry and consider what other licensed professionals can become investigators in trials. Understand the skills needed for new employees that can help your site thrive.

FACILITATOR 
Angela Hirst, Director of Site Alliances, Parexel

PANELISTS 
Seneca Harrison, CEO, Quality Clinical Research
Cathleen Jeffers, FNP-C, CDCES, Business Development Manager/Sub Investigator, Tribe Clinical Research
Caroline Potts, MSc, Clinical Research, MSc, Healthcare and Design, General Manager, MRN
 

 
Optimizing Recruitment: Integrated vs Stand-Alone Sites

*Recruitment
Recruiting participants for research studies is a crucial step in the success of any research project. In this session, we will explore the pros and cons of integrated vs. stand-alone sites and discuss how to optimize recruitment efforts for your study. We will discuss strategies for optimizing recruitment efforts based on the type of site and provide practical tips on how to effectively recruit and engage potential participants, as well as how to ensure that your study meets its recruitment goals.

FACILITATOR 
Lisa Bjornestad, Executive Vice President of Strategy and Growth, DM Clinical Research

PANELISTS 
Todd Albin, MBA, CEO, Cedar Health Research
Julie Dibrell, Director of Customer Engagement, OneStudyTeam
Leah Bouk, Director of Research Services, BEKHealth
Rachel Ovens, MBA, Director, Clinical Operations, Site Planning & Optimization, Boehringer Ingelheim

 

 
Missing Invoiceables: Don’t Leave Money on the Table

*Finance
Are you leaving money on the table? How much? Discover the non-procedural line items you might be unaware of for your studies. Come join this exceptional panel of industry experts as they discuss commonly missed invoicable items and learn how the SCRS Site Invoiceables Toolkit can assist in your budget planning.

FACILITATOR 
Rodrigo Garcia, MD, MS, Vice President, Sites and Patients Center of Excellence, PPD, part of Thermo Fisher Scientific

PANELISTS 
Matt Lowery, ACRP-CP, CCRC, Director of Clinical Research, Suncoast Neuroscience Associates
Robin Marcus, RN, BSN, Head of Global DCT Market Development, Marken
Eden Stein, MBA, MSc, PMP, CCRC, Executive Director, Patient Insights & Engagement, Centricity Research
Wenoah Veikley, BScN, RN, CEO & Chief Clinical Officer, AXCES Research Group

 

 
Making Accurate & Valuable Revenue Projections & Pipeline Forecasts

*Finance
Forecasting and revenue projections are essential for businesses to plan and allocate resources effectively. In this session, we will discuss the best practices for combining pipeline and backlog to project accurate revenue for a site. We will explore various forecasting techniques and learn how to use historical data to make informed predictions about future revenue.

FACILITATOR 
Chris Hoyle, MBA, CEO & Founder, Elite Research Network

PANELISTS 
Lauren Chazal, MBA, Chief Business Development Officer, Headlands Research
Karin Gulbrandsen, Sr. Director, GCO, US Cross TA, Janssen
Carlos E. Orantes, Chief Executive Officer, Alcanza Clinical Research

 

 
Establishing Successful Industry Partnerships

*BD & Relations
What does “partnership” truly mean when it comes to successful industry relationships? Hear best practices for establishing rapport and building strong industry partnerships from sites and sponsors. In this session, you will learn how to create valuable, long-term industry relationships by understanding the fundamentals of proactive and timely communication strategies.

FACILITATOR 
Mike Clay, MSJ, Vice President, Global Site Selection & Strategy, Fortrea

PANELISTS 
Wes Bonner, VP, Strategic Relationships, DM Clinical
Russell Delgiacco, Associate Director, Investigator Engagement, Lilly
Alexandra Moens, PharmD, Product Marketing Senior Director, H1
Amanda Rangel, MS, Senior Vice President, Business Development, 83bar
 

 
Regulatory & FDA Guidance on Diversity, Equity & Inclusion: What Sites & Industry Need to Know

*Diversity
Have a front-row seat to a dynamic fireside chat regarding the impact of the FDA and other regulatory agencies’ mandates, guidance, and laws. Our expert panel will share key perspectives to enhance diversity in clinical trial designs and shed light on critical information the industry must grasp for the inclusion and engagement of diverse participants.

FACILITATOR 
Diana Foster, PhD, CEO, Total Diversity Clinical Trials

PANELISTS 
Melissa Gottschlich, PA-C, MPAS, Director, Site Network, Accellacare (ICON)
Korin Martin, MS, Director, GCTO PMO, Merck
Tony Pearson, JD, MPH, Senior Director, Diversity and Inclusion in Clinical Trials, Lilly
 

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Breakout Sessions IV
February 21, 2023 • 0 Comment

Risks of DCTs & How to Mitigate Them

*Legal
What CTA clauses do sites need to consider to mitigate risk when participating with DCTs? This session will evaluate potential risks, such as PI oversight, to help you construct a risk mitigation plan for your site.

FACILITATOR 
Deena Bernstein, MHS, Independent Consultant

PANELISTS 
Kyle Hogan, President, ProofPilot
Joseph Kim, Chief Strategy Officer, ProofPilot
Adrian McDonald, Director, Site Optimization and Solutions, Illingworth Research Group (a Syneos Company)
Steve Satek, MBA, CCO, Flourish Research

 

 

Site Optimization to Maximize Profitability

*Finance
With inflation and costs at an all time high, it’s critical to evaluate your site’s fixed costs and identify opportunities to reduce them. This session will share cost-saving methods and how to modify site operations to maximize site efficiency and profitability.

FACILITATOR 
Jeff Repper, Executive Vice President, Strategic-Site Initiatives, Transformative Pharmaceutical Solutions

PANELISTS 
Jane Hiatt, Executive Director, Site Management & Monitoring and ESD, Merck
Luis Russo, MD, PhD, CEO, Director, IBPCLIN Care Access Brazil
William Smith, MD, CEO, Alliance for Multispecialty Research, LLC

 

 
eRegulatory & eSource: The Pros & Cons

*Operations
As eRegulatory and eSource systems become more common at sites, it is important to understand the differences between electronic and traditional regulatory processes as well as source data collection. This panel will discuss barriers to moving to electronic regulatory and source document platforms and if they are right for your site.

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

PANELISTS 
Henry Kravchenko, CEO, Clinical.ly
Jeffrey Smyth, MS, President/Executive Director, TrueBlue Clinical Research
Jeff Ventimiglia, SVP, Product Enablement & Operations, Medidata

 

 
Understanding Different Site Operation Models: Balancing Relationships & Success for Growth

*Operations
Join us for an open discussion on the pros and cons of site operation models and how they affect relationships with sponsors, CROs, and other sites. How do you differentiate your site so everyone wins? This session will unpack learnings from operating different site models so you can determine the best way to organize your site business.

FACILITATOR 
Jennifer Byrne, CEO, Javara

PANELISTS 
Justin Bandura, JD, Sr. Associate Director, Strategic Alliance Clinical Development & Operations, Boehringer Ingelheim
April Coburn, MLA, Associate Director, Therapeutic Area, ICON, Plc
Cynthia M. Dukes, PA, MT, Chief Business Officer, Benchmark Research
Richard Pollak, DPM, MS, Advisor/Consultant

 

 
Privacy, Data & Protection: What You Need to Know

*Regulatory
The need for privacy protection and secure information disclosure for clinical trials is an ongoing challenge. This session will discuss how HIPAA, protected health information (PHI) and personally identifiable information (PII) apply to your site and prepare you for EU privacy regulations that impact sites globally.

FACILITATOR 
Hans Christian Hoeck, MD, PhD, Founder, TrialCare AG

PANELISTS 
Al Pacino, General Manager, BlueCloud by HealthCarePoint
Michael Swartz, JD, Director Global Site Agreements, Merck
Marc Wartenberg, Director, Security Corporate Qa & Compliance, CRIO
 

 
How to Stand Out as a Site & Be Selected for Studies

*BD & Relations
Do you want your site to stand out during feasibility? Come learn from successful sites and sponsors on how to become a partner site of choice. Understand the key elements of the study startup process and get tips and metrics from sponsors and CROs to help improve your site’s visibility.

FACILITATOR 
Barry Lake, CEO & Co-Founder, Devana

PANELISTS 
Jillian Agnew, RN, CCRC, Senior Clinical Research Nurse, St. Johns Center for Clinical Research
Karen McIntyre, MSc Clinical Trials, VP, Global Site Alliances, Parexel
Lindsey Morales, Associate Director, Clinical Operations, Gilead
Karen Pypniowski, Vice President, Feasibility & Site Operations, Circuit Clinical

 

 
The Foundations of Consenting in Modern Times

*Recruitment
What do we need to do to assure our patients continue to be consented in the right way, given the tremendous increase in trial complexity? Join us for an engaging discussion as we compare traditional consenting practices with modern consenting needs. Leave this session understanding the basics of consenting effectively and translating that to compliance.

FACILITATOR 
Tarra Shingler, MS, CCO, StudyKIK

PANELISTS 

Harpreet (Isha) Monga, M. Pharm, Postdoc, GCSRT, Research Scholar, Clinical Researcher Manager, Neuro Pain Center
Michelle Hartmann, MS, CCRP, Director, South Broward Research
Dawn Strelow, MSN, MBA, RN, Associate Director, Client Engagement, Patient Consent, IQVIA Technologies

 

 
Financial Implications of Diversity, Equity & Inclusion Strategy

*Diversity
This hot-topic panel discussion focuses on the financial implications of incorporating diversity into your organization’s strategy. We know that new diversity requirements will come with financial needs and changes at the site level, and this session will discuss what some of those changes are and how we ensure they are addressed.

FACILITATOR 
Angel Akinbinu, Senior Director, Clinical Trial Diversity Syneos Heath

PANELISTS 
Audrey Escobedo-Escotto, MD, MPH, Vice President, Emerson Clinical Research Institute
Van Johnson, Vice President, Business Development, Velocity Clinical Research
Ana Marquez, MSF, CRCP, Chief Diversity Officer, Flourish Research
Ashley Moultrie, Director, DEI & Community Engagement, Javara

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