- Why You Should Register?
- 2020 Agenda
- 2020 ARCHIVES
This will be an open discussion about site acquisitions. We will share several critical issues that you need to be aware of as you undertake this process. This will include discussion of essential information for evaluation. There will be discussion of basic systems that will be expected to optimize your value.
Most sites are still utilizing paper, shared drives or other similar systems to organize, manage, and access research study documents. Site staff are already overwhelmed with conducting high-quality research with limited time and money to invest in process improvement. Further, the burden of work has become even heavier and more pressing during the COVID-19 pandemic. As a result, simple shared drives or similar document management systems can no longer provide the speed, efficiency or quality needed. The answer: Sites need to look beyond simple eRegulatory solutions and focus on “next-generation” document management platforms. This interactive panel will provide insight on how to select an innovation-driven solution that best meets sites’ needs.
Rick Arlow, Founder & CEO, Complion
Mandy White, MS, CCRP, Supervisor, Regulatory Affairs, Cook Children’s Health Care System
As a result of Covid-19, the industry has rapidly adopted paperless systems to allow for electronic source, paperless regulatory site files, remote monitoring, virtual visits via decentralized trial portals, a faster transmission of data that eliminates the need for transcription and more. This webinar will explore the great benefits that these systems have brought to our industry in this challenging time as well as the opportunities this transition has presented. We will also openly discuss the long term impacts of these systems for sponsors, CROs and sites as we move into a completely paperless world.
Rick Greenfield, BBA-IS, CEO, RealTime CTMS
Nathan Levens, Director of Virtual Solutions & Technology, RealTime CTMS
Diversity in clinical research has become a key focus area throughout the industry. In addition to the need to build a more inclusive environment, diversity among participants is vital to ensuring the development of effective treatments. In this session, we’ll explore current efforts and best practices for fostering diversity within clinical trials and provide guidance to promote diverse recruitment across your organizations. We’ll focus on actionable steps you can take to improve recruitment and highlight how the shift to virtual and decentralized trials is the perfect time to focus on inclusive recruitment initiatives.
Jivan Achreja, CTO and President, Solutions & Technology, Advarra
The purpose of the workshop is to explore strategies for sponsors to partner with sites to improve the patient experience in clinical trials using digital technology (apps, web platforms, clinical trial patient portals, etc.). Learnings from the workshop will enable the discovery of a balanced approach to enhance the patient experience between sponsor-driven technology and site-driven technology. These learnings will guide the design of technology platforms that patients find valuable and which compliment (and not interfere with) the technology currently in use by sites.
Hassan Kadhim, Global Head Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations, Global Development Operations, Bristol Myers Squibb
Joe Dustin, Head of Clinical Innovation, Bristol Myers Squibb
Pete Stetson, MD, MA, Chief Health Informatics Officer, Deputy Physician in Chief, Memorial Sloan Kettering Cancer Center
To say that 2020 kicked off with a lot of changes would be a massive understatement. Sadly, many sites have closed. Those who survived and thrived adapted their site operations and workforce. Not only are increased pipelines and rising competition prevalent, but also some roles are being displaced due to related site and sponsor adjustments. Sites will need to balance the “COVID regulatory clean up” with a plan moving forward. How can you proactively address the industry shift while also navigating these pressures as efficiently as possible? Join our workshop to gain insights on how COVID-19 has forever changed the workforce and what steps you need to take moving forward.
Molly Downhour, MHA BSN NEA-BC OCN CCRC, Executive Director Clinical Research, Medix
Nicole Mills, MS-CRM, ACRP-CP, Director of Clinical Research, Medix
At the center of the clinical research ecosystem, clinical trial sites have not been immune from the larger forces currently disrupting the healthcare industry—issues being exacerbated by COVID-19.
Over the last 7 months, we have seen increasing pressures being placed on sites due to the pandemic, a problem we are calling “site crunch.” As we continue to move forward together, the question must be asked of all stakeholders in the ecosystem, “How can we help our sites adjust to this ‘new normal’ as they look to conduct research trials going forward?
Looking back to 2015, we have seen a sharp decline in sites and investigators choosing to participate in clinical research, while sponsor pipelines and clinical trial starts have exponentially risen. Fast forward to 2020, clinical trial sites are being asked to do more with less due to widespread staffing shortages caused by the pandemic. With trials increasing in complexity each year, clinical research sites are experiencing significant “crunch,” and we must anticipate the ways in which we can help our sites grow as their research pipelines grow.
Molly Hair, Director of Site Engagement and Management, WCG ThreeWire
Seth Nelson, Vice President of Clinical Strategic Solutions and New Product Development at WCG ThreeWire