Master Workshops

Sponsored by CSSi
Building a Successful Recruitment Plan & Budget
Demystify & Understand Contract Terms & Their Impact on Your Site
Finance Can be Fun! Understanding Best Practices in Clinical Research Billing
It’s Time to Level Up! Assess and Enhance Your Organization’s Payment & Enrollment Processes
Right Team – Right Now
Prepare Your Site: Electronic Consent Is Coming



Building a Successful Recruitment Plan & Budget

Learn how to efficiently plan and budget for successful patient recruitment. Targeting the correct audience is a key component of the recruitment process, and we will explore the steps on how to effectively develop a marketing strategy to do so. Understanding how to best research, identify and reach your patients through a multi-platform strategy can help expedite the recruitment process.

Chris Trizna
President, CSSi


Demystify & Understand Contract Terms & Their Impact on Your Site

This workshop will focus on the role of the contract and indemnification when the sponsor/CRO is seeking the services of a clinical site to conduct research to support a drug or device application on marketing. The contact sets out the expectations of both the clinical site and the sponsor/CRO. The discussion will focus on some of the contract issues, with a particular emphasis on indemnification. What does indemnification mean and what obligation or rights do you gain with indemnification? There will be time toward the end of the workshop for questions and answers.

Gary L. Yingling, MSc, JD
FDA Regulatory Sr. Counsel, Morgan, Lewis & Bockius LLP


Finance Can be Fun!
Understanding Best Practices in Clinical Research Billing

Billing is a constantly evolving and challenging component for clinical research sites. Successful management of this operational activity is a strong indicator of a successful site; failure to properly manage billing can result in dire consequences for the site. This workshop will discuss billing best practices for sites, utilize tools and technology to maximize revenue and minimize billing complications.

Michael Bonavilla
Sr. Sales Executive, Bio-Optronics


It’s Time to Level Up! Assess and Enhance Your Organization’s Payment & Enrollment Processes

During this interactive workshop, attendees will be introduced to an operational maturity assessment tool intended to assess and guide improvements to research sites’ clinical research processes. Attendees will complete a questionnaire to better understand the current state of their payment and enrollment processes. Participants will walk away with a clear vision and actionable strategies they can employ to reach the next step of operational maturity.

Regina Schwind
Director of Research Operations, Forte


Right Team - Right Now

Every hire really counts! Employees need to be in the right roles, and it is up to management to ensure the opportunity fits the employees' and site's needs. You will learn how to recruit the right talent for your site and evaluate if you have the right people in the right roles. Strategies and tips for employee growth and retention will enhance site sustainability.

Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC
Director of Strategic Solutions- Clinical Research, Medix

Bridget Gonzales, CCRC
Clinical Research Account Executive, Medix

Sandra Jovanovic, MBA
Sr. Manager of Talent Innovation, Medix


Prepare Your Site: Electronic Consent Is Coming

If your site is not already using electronic informed consent (eConsent) technology, it will be soon. If you are using eConsent now—or will be in the future—it is important to know the implications on your site. Have you updated your policies, procedures, and training materials? Is your technology certified with all the right acronyms: HIPAA, HITECH, PIPEDA, Part 11, COPPA? Is your site ready? In this session, we will look at the practical implications for preparing your site for eConsent. Subject matter experts will discuss the various types of tools available, how those tools are viewed through the IRB, and what you need to do at your site to make preparations. Lastly, you will hear the benefits of using an eConsent tool and how your site will be more attractive and better aligned to handle eConsent-enabled studies…if you are ready.

VP of Client Services, Kinetiq

Mitchell Parrish, JD, RAC, CIP
VP & General Counsel, Kinetiq

Location: See Program for Room Location Date: October 6, 2017 Time: 8:00 am - 10:00 am