Breakout

Breakout Session V & VI – Budgets, Contracts & Finance

September 2, 2020 • 0 Comment

Track Category Sponsored by WCG

1:30 – 2:30

Hidden Costs: Remote Monitoring & How to Budget for It

As industry continues to embrace and transition to remote monitoring, the potential staffing and financial burdens on sites mount. This session will help you evaluate the costs and value-add of remotely monitored trials, and understand what line items to keep in mind when negotiating study contracts and budgets.

Jennifer Bush, Sr. Director, Life Sciences Product Strategy, Oracle
Ryan Jones, MBA, CEO, Florence Healthcare
Heather Kemp, Consultant, Trial Capabilities Business Operations, Lilly
Al Peters, Managing Partner, ClinX

2:45 – 3:45

Lessons from the Trenches: How COVID-19 Reshaped Study Budgets

The entire world, including the clinical research industry, has been turned upside down by the COVID-19 pandemic. With trials halted or closed to new enrollments, increased remote monitoring, staff lay-offs and more, we have entered a new paradigm that we must learn to navigate. Looking in the rearview mirror shows us new budget considerations that must be accommodated. This session will help you navigate “the new normal” so you are prepared and informed in the future.

Catherine Click, Director, Clinical Pricing & Analysis, Greenphire

Eric Cole, Local Study Manager, AstraZeneca
Karen McIntyre, MSc, 1st Executive Director, Syneos Health
Steve Satek, MBA, Founder & President, Great Lakes Clinical Trials

Breakout Session V & VI – Business Development

May 7, 2020 • 0 Comment

1:30 – 2:30

Future Therapeutic Trends: Considerations When Expanding into New Indications

Looking to expand into other therapeutic indications? Your business development must extend beyond your usual efforts and feasibility questionnaires. As pipelines shift direction and new therapeutic area opportunities are identified, discover what proactive steps can be taken to diversify your therapeutic portfolio and position your site as a leader in your desired field.

Chris Hoyle, MBA, Executive Director, Elite Research Network
Karri Venn, RD, CDE, CCRC, President, Research, LMC Manna Research

2:45 – 3:45

Common Contract Mistakes & How to Correct Them

Big or small, most contract mistakes are usually uncovered when you come face-to-face with a problem. This session will walk sites through the most common mistakes found in clinical trial agreements (CTAs) and the steps you can take to resolve them, or avoid them altogether.

Luke Goodpaster, Senior Project Manager, WCG-PharmSeek
Matt Lowery, BS, ACRP-CP, CCRC, Executive Director, CRBD+
Michaela Vancova, Ing., MPH, CRCP, President & Owner, Slovak Research Center
Vivienne van de Walle, MD PhD CPI, Director, PT&R

Breakout Session V & VI – Regulatory & Compliance, Recruitment & Retention

September 2, 2020 • 0 Comment

Track Category Regulatory & Compliance, Sponsored by Advarra
Track Category Recruitment & Retention, Sponsored by SubjectWell

1:30 – 2:30
Risk-Based, Centralized, Remote Monitoring, Say What? Quality Control, Explained

If centralized and remote site monitoring (RSM) were not yet on your radar, the COVID-19 pandemic brought it to your doorstep. But what exactly are they and what do they mean for sites? Further, how does all this relate to risk-based monitoring (RBM)? In this session you will hear lessons learned from experience and understand what sites should expect as a site from the future of monitoring.
Beenu Kapoor, MBA, MS, Vice-President, IQVIA
Summer Iverson, MSHS, CCRA, Process & Standards Lead Global Site and Study Operations, Pfizer
Melissa Poindexter, RN, BSN, President, Advances in Health Research
Shivani Shah, MS, Director of Operations, DM Clinical Research

2:45 – 3:45

Sustaining Patient-Centricity Amidst Adversity

Achieving patient centricity is easier said than done, yet it is important that all stakeholders strive to remain patient-centric even when the going gets tough. This session will highlight how stakeholders maintained patient centricity through the COVID-19 pandemic, including strategies deployed and the resulting outcomes.
Miaesha Campbell, Director, Patient Recruitment and Retention, Medpace
Ivor Clarke, CEO, SubjectWell
Scott Gray, President & CEO, Clincierge
Chrystal Oley, Site Development Lead, AstraZeneca

Breakout Session V & VI – Site & Study Operations

September 2, 2020 • 0 Comment

Track Category Sponsored by CRIO

1:30 – 2:30
Are Your Key Performance Indicators Aligned with Sponsor Expectations?

What are key performance indicators (KPIs), and how can they be utilized to operationalize your site and successfully market your strengths to sponsors and CROs? Join this session to learn how to ensure your KPIs are aligned with sponsor expectations and how to engage them in marketing efforts.

Anne-Marie Baughn, RN, BSN, MSN, Director, Business Development, RxTrials
Barry Lake, CEO, Devana Solutions
Chris Monaghan, Associate Director, Site Strategy, ClinEdge
Earl Seltzer, Senior Director, Covance

2:45 – 3:45

What Sponsors are Really Looking for in Your Site Feasibility Surveys

You’ve found the perfect study for your site, and you completed the site feasibility survey on time…just to find out two weeks later that you didn’t make the cut. Why? What additional information or tactics would have improved your odds? Participate in an interactive feasibility exercise to help you better understand what sponsors and CROs are looking for and what sites should know when completing feasibilities.

Sean Cunningham, MBA, Director, Strategic Account Lead, Janssen
Greg Folz, CCRP, Adminstrative Director, Research Institute of Deaconess Clinic
Marisa Rackley, BS, MHA, PMP, Director, Vertex
Łukasz Więch, MBA, Partnership Manager, Accelerated Enrollment Solutions

Breakout Session III & IV – Budget, Contracts & Finance

May 7, 2020 • 0 Comment

Track Category Sponsored by WCG

1:30 – 2:30
Negotiating Like a Pro: The Low-Down on Study Budgets

As study budgets become more complex and less transparent, site staff need to become increasingly savvy with their negotiation tactics. Whether you have someone who manages your budgets or not, this session will provide an overview of all-things-budget including pass-throughs, overhead, procedural justification, and how to ask for a higher budget and actually get it.
Melynda Geurts, MS, SVP, Business Operations, Total Clinical Trial Management

Hans Christian Hoeck, MD, PhD, CEO, Trialcare Research

Ana Marquez, MSF, CEO, Clinical Site Partners, LLC

Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP, Manager, Kelly Willenberg & Associates

2:45 – 3:45

Virtual Trials 101: The Nuts & Bolts of Remote Practices

Whether or not your site is ready for virtual trials, they’re here. This reality was blasted home to us all as COVID-19 circulated the globe and forced us to embrace remote trials…whether we liked it or were ready, or not. This “nuts and bolts” session will walk you through everything you need to know from insurance considerations and budget considerations, to operational challenges and how to navigate unforeseen.
Kim Kundert, RN, BSN, VP Operations, VirTrial

Kamala Maddali, DVM, PhD, Vice President, Strategic Alliances and Collaborations, Deep Lens

Chris Pitcherella, MS, MBA, Director, Clinical Site Operations, Pfizer

James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Institutional Services and Strategic Consulting, Advarra

Breakout Session III & IV – Human Resources & Legal, Recruitment & Retention

September 1, 2020 • 0 Comment

Track Category Human Resources & Legal, Sponsored by Medix
Track Category Recruitment & Retention, Sponsored by SubjectWell

1:30 – 2:30

Driving Site Success with Staff Success

With the recent changes and destabilization in the clinical research industry due to COVID-19, the value of having an outstanding site staff cannot be overstated. Successful sites have organized, well thought-out and thoroughly documented processes for hiring, onboarding, and training staff. Learn what it takes to create and maintain a top-notch site staff.

Todd Albin, MBA, CEO, Cedar Health Research
Molly Downhour, MHA BSN NEA-BC OCN CCRC, Executive Director Clinical Research, Medix
Lindsey Morales, Senior Manager, Site Partnership, Covance
Karri Venn, RD, CDE, CCRC, President, Research, LMC Manna Research

2:45 – 3:45

Diversity in Clinical Trials From an Investigator’s Perspective

Michael Koren, MD, FACC, FAPCR, CPI, CEO, Jacksonville Center for Clinical Research

Breakout Session III & IV – Regulatory & Compliance

September 1, 2020 • 0 Comment

Track Category Sponsored by Advarra

1:30 – 2:30

Quality Management: Not Only the Sponsor’s Responsibility!

ICH guidelines put the responsibility of quality management squarely on the sponsors’ shoulders. But that doesn’t mean sites shouldn’t have their own quality management plan! Understand the importance of quality management at the site level and learn how to set up your own quality management plan.

Stephanie Berger, Director, Clinical Research, Urology Clinics of North Texas
Julia Brenner, MHA, Finance & Regulatory Manager, Coastal Pediatric Research
Annabel Elliott, Senior Manager, Quality Assurance, Accellacare
Nicole Huff, SSGBC, ACRP-CP, CCRC, Senior Study Coordinator, Training and Compliance Officer, Suncoast Neuroscience Associates

2:45 – 3:45

eSolution Innovation & Regulatory Considerations

Implementing eRegulatory, eSource and other patient-facing technology that allows clinical trials to move to a remote or hybrid model is on the rise. This is thanks in part to COVID-19, yet this path was paved long before the pandemic began. Join this session to understand the hurdles encountered by those who have already adopted these technologies, and navigate the related regulatory considerations.

Rick Arlow, Founder & CEO, Complion
Williams Dirkes, MD, MBA, President, SentralBinders
Tam Nguyen, PhD, MBA, FRSHP, FIML, Deputy Director of Research, St Vincent’s Hospital Melbourne – Australia
Raymond Nomizu, JD, CEO, CRIO

Breakout Session III & IV – Technology

September 1, 2020 • 0 Comment

Track Category Sponsored by Realtime

1:30 – 2:30

Effective Technology Management Approaches to Boost Your Site

Technology can drastically improve efficiencies and processes if adoption and integration keep both the site and patient in mind. Sponsors, CROs and Solution Providers must keep site burden in mind when deploying new technology to ensure its success. Join this session to learn how to problem-solve and effectively adopt technology for the benefit of all parties.

Anna Argyris, MSHS, CCRP, Director, Site Solutions, Veeva
Jackie Kent, EVP, Head of Product, Medidata Solutions a Dassault Systèmes company
Casey Orvin, Senior VP of Pharmaceutical Relationships, StudyKIK
Rick Ward, VP, Commercial Operations, Trifecta Clinical

2:45 – 3:45

Innovative Recruitment Tools: The Expansion of Telemedicine

Tele-trials and remote visits are becoming a reality as attention shifts to reducing patient travel time and increasing patient flexibility. Join this session to learn how to successfully implement telemedicine and remote visit practices as a recruitment tool for your site.

Peter Falzon, President & CEO, Ripple Science
Michael King, Senior Director, Sanofi
Robin Marcus, RN, BSN, CSO, GlobalCare
Amanda Rangel, MS, CCRC, EVP, Virtual Trial Solutions, VirTrial

Breakout Session I & II – Business Development

August 26, 2020 • 0 Comment

1:30 – 2:30
Reinventing Your Site: During & After COVID-19

The COVID-19 pandemic has changed clinical research forever. As a result, sites have had to adopt new technologies, train and coach staff, implement new processes, and create an entirely new model of conducting studies. Communicating these changes and new capabilities to sponsors, CROs and patients is essential for ongoing as well as new study opportunities. This session will explore marketing strategies and “the message” sites must create and communicate to stakeholders now and going forward.
Lisa Bjornestad, Director, Site Alliance, Americas, Parexel

Christina Brennan, MD, MBA, VP, Clinical Research, Northwell Health

MarieElena Cordisco, MA, NP-C, APRN, CCRC, AVP Clinical Trials, Research and Innovation, Nuvance Health

Al Pacino, President, BlueCloud by HealthCarePoint

2:45 – 3:45

Site Business Health: Withstanding Disruption During a Pandemic

Clinical research sites that intimately know their finances and take proactive steps early to prepare for and anticipate disruptions stand a better chance of surviving and even coming out of a disruption stronger. Hear from business owners what strategies they took prior to, during and following major disruptions that resulted in surviving and even thriving.
Kay Scroggins, RN, President & CEO, Clinical Trials of Texas

William Smith, MD, MBA, CEO, Alliance for Multispecialty Research

Christin L. Trujillo, Financial Consultant, Skytale Group

Emily Wike, Director, Strategic Partnerships, Devana Solutions

Amanda Wright, VP, Javara

Breakout Session I & II – Recruitment & Retention

August 27, 2020 • 0 Comment

Track Category Sponsored by SubjectWell

1:30 – 2:30

Diversity in Clinical Research-The Time is Now

What steps have you taken to address diversity in clinical research? We are past the point of defining the issue and discussing ideas, now is a call to action. The panel of industry representatives will provide insights into the actions in progress and what we can do as the clinical research community.

Dan Milam, Vice President, Global Engagement, SCRS
Alicia C. Staley, Senior Director, Patient Engagement, Medidata Solutions a Dassault Systèmes company
Altair Silva, Director, Patient Recruitment Strategy, Parexel
Lorena Kuri, Head, Diversity Strategy, Bristol-Myers Squibb
Jackie Kent, EVP, Head of Product Medidata Solutions a Dassault Systèmes company

2:45 – 3:45

Enrollment Wizardry: How to Support Enrollment Before the Study Even Starts

Enrollment begins before the study starts! This session will provide you with tools needed to maximize lead time to ensure strong enrollment and hit milestones from the get-go. Patient pre-screening, recruitment campaign best practices, and what gets and keeps patients engaged will be addressed.
Alexa Florea, BS, PMP, Country Clinical Operations Leader, Roche

Steven Geller, MD, FACP CPI, Medical Director, Centennial Medical Group/RX Trials

Gretchen Goller, MSW, Global Head, Patient Recruitment and Retention Solutions, ICON

Lance Nickens, President, The Patient Recruiting Agency

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