As we begin our third day of the Global Site Solutions Summit, Hear from the SCRS project team share an update on the exciting initiatives and special programs SCRS is known for.
The year 2020 will forever be marked as the “Year of the Pandemic” with the impact felt in our personal lives, by our nation, and across the world. Through the tragedy, stories of innovation and creative problem-solving also emerged. How did innovation outlast the emergency? Join this session to hear what solutions emerged that may make a lasting positive impact on clinical research, drug development and our society.
Summit Roundtable: Oncology
Sandy Smith, Vice President, US Oncology Research & Clinical Services
Archana Sah, Clinical Operations Executive, Roche
Summit Roundtable: COVID-19 Impact
Steve Satek, President, Great Lakes Clinical Trials
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
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
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
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
Summit Roundtable: Hidden Costs & Budgeting
Summit Roundtable: Site Business Development
Mara DiMattia, Assoc.Director of BD, Integrative Research Associates
Summit Roundtable: Recruitment & Retention
Summit Roundtable: Site Operations & Expectations
With the COVID-19 pandemic, the impact on clinical trials is unmistakable. Digital innovations that might have once taken months or years to be adopted have been integrated into practice in days or weeks. Digital operating models – such as telemedicine, remote monitoring, and synthetic controls that have been discussed and piloted endlessly are now enabling clinical trials to move forward. Even when the COVID-19 outbreak is contained, it’s unlikely these digital transformations will go away. This session will explore how sites, sponsors, and CROs are embracing new technologies and digital operating models while positioning themselves for success in the long term.
