Regulatory & Compliance

Master Workshop
May 7, 2020 • 0 Comment



Advanced eRegulatory Solutions for COVID-19 and Beyond (REG)
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

The Transition to Paperless Technology in Clinical Trials (OPS, TECH)
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

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Master Workshop
July 15, 2020 • 0 Comment



Clinical Trial Financial Management Technology 101 Workshop: Leveraging Technology to Lower your Site Burden ($, TECH)
Technology is changing the way clinical trials are being conducted. In this session, you will learn the core Clinical Trial Financial Management technologies that are powering clinical trials today and how they are improving the site experience. In addition, we will talk through some of the more advanced technologies that are becoming mainstream and how you can engage with your CROs and/or Sponsors to ensure they are leveraging these technologies.

Jeffrey Kearney, VP, Product Management Payments, Medidata Solutions, a Dassault Systèmes company
Tom Creswell, Director Product Management, Medidata Solutions, a Dassault Systèmes company
Shelley Doruos, Director of Product, Clinical Trial Planning & Budgeting, Medidata, a Dassault Systèmes company

Looking to be Acquired and What to Expect
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.

William B. Smith, MD, CEO, Alliance for Multispeciality Research
Neil McCarthy, Managing Director, Fairmont Partners Investment Banking
Sean Karamchandani, Partner, Presistance Capital Partners
Kumar Muthalagappan, CEO, Chairman, Oncacare

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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

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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

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