Sponsored by Advarra
- Summit App
*Sites Only Session
Seemingly overnight, our lives changed. Our personal lives, our professional lives, and the lives of our co-workers, families, and friends. But with every change comes opportunity. This is particularly true in the world of clinical research. The changes that have been thrust upon us all accelerated a significant transformation of how we do the important work that we do. At the heart of this transformation is the concept of “bringing clinical research to the patients” through decentralized clinical trials (DCT). But how has this impacted the sites? After a brief overview of Janssen’s approach and activities related to DCTs, this interactive session will focus on the challenges and opportunities for sites and what actions sponsors can take to improve the overall site experience.
During the breakout session, site participants and Janssen staff will openly discuss specific topics related to decentralized clinical trials. The results of these conversations will be shared with the larger group for further discussion. Together, we will consider what factors of DCTs have the greatest opportunity to create a better clinical trial experience for sites and identify actions that promote real collaboration in trial conduct.
Sponsored by Knice Solutions
Patients are at the center of clinical trials, but often left out of the entire trial design process. Partnering with patients early and incorporating their voice in solution development not only enhances the patient experience, but also increases engagement and retention rates. Join us in an interactive workshop to learn how easy it is to infuse the patient perspective into your next solution offering.
Alica C. Staley, MBA, Vice President, Patient Engagement, Medidata Solutions
Kelly McKee, MA, Vice President, Patient Registries and Recruitment, Medidata Solutions
Anne Marie Mercurio, Patient Advocate
As sites, CRO’s and sponsors adapted at speed to find methods to ensure patient safety and continuity of clinical research during the medical emergency we now must take time to reflect. Decentralizing clinical trials must meet the needs of patients, sites and sponsors. To be successful, the industry and sites must work together to harness experience and expertise, defining best practice and increasing optionality and inclusivity of clinical research as a choice for all.
Join Syneos Health Decentralized Solutions team to learn how to adopt DCT technologies and methodologies that work for sites, patients and sponsors.
Scott Scarola, VP of DCT Operations, Syneos
Marie Emms, VP Site & Patient Access, Syneos
Lisa Kodis, MSN, RN, Associate Director of Research Nursing, Illingworth Research
To achieve health equity, it is critical that clinical trials are inclusive of the populations that will ultimately use the medicine or therapy. In this interactive session, presenters from Janssen, the Pharmaceutical Companies of Johnson & Johnson, will share best practices for ensuring diverse and inclusive enrollment in clinical trials through close collaboration with trial sites, operational excellence in trial design and, most importantly, building trust in clinical research in local communities.
Ramona Burress, MBA, PharmD, Associated Director, Diversity & Inclusion in Clinical Trials, Janssen
Luis Arroyo, Specialist, Diversity & Inclusion in Clinical Trials, Janssen
The pandemic irrevocably scrambled the clinical trial operating model, accelerating a number of trends. These trends include more decentralized, direct-to-patient elements, such as remote monitoring and increased reliance on digital marketing for patient recruitment. Sites that succeed will be those that adopt flexible, technology-centered practices to adapt to these changes. In this session, speakers will advise sites on best practices, sharing a case study and integrating results from a recent site survey.
Raymond Nomizu, CEO, CRIO
Jessica Branning, CEO & Founder, Clincloud
Sponsored by Knice Solutions
The clinical trial landscape continues to evolve, while the site id and selection process lags behind. As a result, clinical research sites need to continue to push the boundaries of the current site id and selection process framework to showcase why they are the right site for any given trial opportunity. This starts with their ability to bring feasibilities to life by highlighting competitive advantages about their site that uniquely match the needs or mitigate the risks of trial Sponsors.
Sean Rice, MBA, VP of Site Operations, ClinEdge
Mallory Thomas, Director of Site Strategy, ClinEdge
Janet Lusk, Feasibility Manager, Elligo Health Research
Does the General Data Protection Regulation (GDPR) and other modern data protection regulations affect you and your investigator site? Attend this webinar 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 to be in compliance today.
Al O. Pacino II, President/Co-Founder, BlueCloud®by HealthCarePoint
Includes insights from prior business owners who have sold their businesses and insight from the largest private equity firm in the research space.
Mark Blumling, JD, MSc, President and Founder, Headlands Research
Cathy Collins, MSN, Senior Vice President, Site Strategy and Development, Headlands Research
Jim Goldenberg, MD-CPI, FAAN, FAPCR, Chief Medical Officer, Headlands Research
Chris Cugliari, MBA, Director of Corporate Development, Headlands Research
This workshop will explore how new systems are vastly improving the flow of data and documents in clinical research. Concerns and challenges to this industry-wide transition will be addressed, to include: Change management, impact to legacy site processes, increased costs to sites, FDA and regulatory acceptance of these systems and more!
Rick Greenfield, CEO, RealTime-CTMS
Nathan Levens, Director of Virtual Solutions & Technology, RealTime-CTMS
In this interactive session, the facilitators will encourage researchers to share best practices related to the greatest operational challenges faced; and newly created (and perhaps permanent) best practices that overcame obstacles and perhaps resulted in improved efficiency/outcomes. The resulting framework will offer sites a framework for future study success.
Joe Gough, MA, Sr. Accounts Specialist, Strategic Accounts, Greenphire
Decentralized clinical trials. Siteless trials. Hybrid models. Join top industry executives from integrated research organizations, a leading global CRO, and an innovative technology solutions provider to learn how sites should position themselves in the face of a rapidly changing site landscape. Attendees can expect to learn how sites can maintain relevance as the trend towards more patient-centric business models and use of advanced technologies accelerates and thrive by being on the leading edge of embracing change.
Barry Lake, CEO & Co-Founder, Devana Solutions®
Irfan Khan, MD, CEO, Circuit Clinical
Paul Evans, PhD, President & CEO, Velocity Clinical Research
Jeff Kingsley, MD, CEO, IACT Health
Kristen Andrews, CCRC, Senior Director, Site Centric Solutions, Labcorp Drug Development
Now that research sites have learned to navigate a “new normal” after the pandemic, new struggles related to staffing and employee engagement are arising. Clinical research has had a light shone on it throughout the last year, and positions are now more competitive, meaning that attrition at the site level is even more pervasive than before. After an intense year of COVID-19 vaccine and treatment studies, at-home working, and overall challenges related to the pandemic, keeping staff engaged in day-to-day work is more important than ever. In this workshop, we will discuss ways to attract, keep, and retain staff at the site level. We will also discuss some specific case studies and brainstorm potential solutions together.
Brittany Savoca, MS, CCRC, Director of Site Operations, Accellacare
What is PI oversight and what exactly does it mean in the conduct of a clinical trial? What level of involvement from the PI is required? What tasks can a PI delegate to maintain adequate oversight? How do patients’ rights, safety, and well-being fit into the scope of oversight? These are just some of the questions this interactive workshop will tackle head-on with a panel of industry experts providing details on the requirements, guidance, tips, and examples from the sponsor perspective.
Andrew Gordesky, Regional Director, Clinical Quality Management of North America, Merck
Linda Smith Harris, Senior Clinical Research Associate, Merck
Sponsored by CRIO
Enjoy light fare and beverages while receiving a warm welcome to the Global Site Solutions Summit! Membership Committee chairs will present on How to Maximize Your Summit Experience through our engaging agenda and multiple networking opportunities that are offered daily.
Gain insight into trends and metrics to position your site for success. Current survey data on site partnership, finance, study feasibility and start-up will be discussed by a panel of industry leaders. Use the information shared during this solution-focused discussion to make an impactful change at your organization.
In this panel, we will discuss the importance of collaboration within the clinical enterprise. The discussion will include the perspectives of our 2020 SCRS Eagle Award Recipients, Pfizer and Syneos, who will share best practices for effective communication, ongoing feedback, and the advantages of great relationships between sites, solution providers, CROs and sponsors.