October 7

How Sites and Sponsors are Saving Time and Growing Networks with GDPR, “ LIVE” Giveaway (2) $100 Cash Cards

May 7, 2020 • 0 Comment

Sponsored by BlueCloud

Does the General Data Protection Regulation (GDPR) and modern USA data protection regulations affect you?

Attend this event to learn how GDPR and state-by-state data protection regulations like the California Consumer Privacy Act (CCPA) affect healthcare and clinical research business including sites, sponsors, CROs, universities and other industry stakeholders and what you can do today to position your business during and after the COVID-19 pandemic. There will be 2 “live” drawings each for a $100 cash card at the end of the session! Must be present to win!

Welcome

July 15, 2020 • 0 Comment

Welcome to day two of the Global Site Solutions Summit! Come hear from SCRS’s leadership team on what it means to be an SCRS Member, as well as the tremendous progress the Diversity program has made this year.

The Critical and Growing Importance of Equity in Clinical Trials

May 7, 2020 • 0 Comment

Diversity, inclusion and equity in clinical trials has been an ongoing issue in clinical trials despite numerous calls to action. In this session SCRS, FDA and industry representatives will discuss the critical importance of this issue specifically as it impacts the clinical research site. The ongoing work of the SCRS diversity project will be high lighted along with the launch of the industry standard that has been validated and designed by the working group, to measure and assess the sites individual assessment of best practices in diversity.

Networking NOW Break

July 15, 2020 • 0 Comment

Our industry thrives on relationships, so take advantage of the break to make new connections, catch up with colleagues and keep the collaborative spirit alive.

Summit Roundtable: Diversity in Clinical Trials
Julia Yegorova, Project Lead for Advancing Inclusive Research, Genentech
Karen McIntyre, MSc, Executive Director, Syneos Health

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

Networking NOW Break

July 15, 2020 • 0 Comment

Our industry thrives on relationships, so take advantage of the break to make new connections, catch up with colleagues, and keep the collaborative spirit alive.

Summit Roundtable: Budgets & Contracts
Andre Beukes, BProc (Law), Sr. Director, Business Development, Syneos Health

Summit Roundtable: HR & Legal

Summit Roundtable: Regulatory and eSolutions
Mara DiMattia, Assoc. Director of BD, Integrative Research Associates

Summit Roundtable: Technology

Industry Collaboration to Improve the Future of Clinical Research

May 7, 2020 • 0 Comment

2020 is an unusual year. But, it has provided us with an opportunity to improve the ways of working within our industry. Join senior leaders from TransCelerate member companies as they discuss the importance of coming together as an industry (Sites, Patients, Sponsors, Technology Partners, and more) to address unexpected challenges we face today and better our ways of working for the future.

October 7

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