Master Workshops

Sponsored by CSSi
Cracking the Code in Global Grant Payments: Stakeholder Perspectives
Effective eRegulatory & Document Management: What Successful Sites are Doing
Focus on Site Financial Concerns: Transparency, Patient Support, & Reimbursement
Metrics that Matter for Your Site’s Sustainability
Optimizing A Site’s Contribution to Reducing Delays in Clinical Trials
Secrets & Realities to Survive an FDA Inspection
To Become a Rescue Site or Not? Sorting Out the Challenges & Opportunities to Make an Informed Decision



Cracking the Code in Global Grant Payments: Stakeholder Perspectives

Strong financial management is a key indicator of overall site success. Successful sites understand the importance of developing well-defined budgets, flexible contract terms, and timely and accurate payments. Hear the reality of what works—and doesn’t work—on a global scale from variety of stakeholders. Sites will learn first-hand how to gain a transparent, unified view of contract performance and financial management at the site level. You will also learn how to optimize overall financial control in a way that positively affects site negotiations, budget management, transparency reporting, compliance, and reconciliation and forecasting.

Jeannie Inge
Executive Director, PRA Health Sciences

Jeff Stein, MBA, President
Stamford Therapeutics Consortium & New England Research Associates

Brigid Jordan
Sr. Operations & Finance Manager, PRA Health Sciences

Vaughan Jenkins
Sr. Manager, Site Commercial Solutions, PRA Health Sciences

Effective eRegulatory and Document Management - What Successful Sites are Doing

Whether you’re considering eRegulatory or have already started, one of the first considerations is whether to leverage an internal or vendor system. While both options will help you store and organize your electronic documents, each has its own advantages, limitations, and risks.

During this interactive panel workshop, we’ll explore the differences between different eRegulatory and document management tools, and explore best practices and considerations to help you decide which approach is best for your site. Learn real-world experiences directly from successful sites that have undergone this transition. You’ll walk away with actionable advice from for improving compliance, standardization, and efficiency across your site.

Rick Arlow
Founder & CEO, Complion

Sarah M. Dobrosky, CCRC
Clinical Research Manager, Preferred Primary Care Physicians

Bryce Palchick, MD
Physician, Preferred Primary Care Physicians

Neal H. Surasky, CCRC
Director of Compliance, Chesapeake Research Group

Focus on Site Financial Concerns: Transparency, Patient Support, & Reimbursement

If you lack visibility into payments which have been earned by your site or patients or if you want to know more about how to accurately predict the timing and value of your future earnings, you will want to attend this review of site technology solutions focusing on transparency, efficiency, and predictive capabilities. The ability of technology to ‘make it easy’ and remove barriers for financial issue resolution is the focus of this discussion. As a site, you should not have to divert time and attention to the tasks of calculating, creating, or submitting invoices. Nor should you linger in a state of uncertainty as to the timing and value of future payments. You should instead have payments arrive as expected based on the calculations determined by a data-driven process initiated immediately upon occurrence of your contracted payment triggers. Corrections and reconciliations should likewise follow any changes in the data. Finally, your future earnings should be easily determined based on trial activity to date combined with the parameters of your negotiated contract terms.

Lorie McClain, MS
VP, Product Management, Product Development & Technology,

Metrics that Matter for Your Site's Sustainability

Undoubtedly, one of the hot industry buzzwords in the clinical trials sector is “metrics.” Applying the definition to our industry, ‘metrics’ would be defined as “a standard for measuring or evaluating clinical trial sites, especially one that uses figures or statistics.” Explore why metrics to evaluate a trial site’s effectiveness have become so critical (hint: it’s all about pressure to reduce clinical trial cycle time), which metrics are most valuable to sponsors and CROs, and how a site of any size can begin to start tracking and presenting these metrics to win more studies.

Bill Fugate
Manager, Sites & Patient Access, INC Research/inVentiv Health

Barry Lake
CEO, Devana Solutions, LLC

Cindy Tremblay
GM & Director, Training & Development, Devana Solutions, LLC

Amanda Wright
Executive Director, Greater Gift

Optimizing A Site's Contribution to Reducing Delays in Clinical Trials

Strategies to execute to solve the bottleneck of clinical trial conduction from feasibility to execution is today's priority! Execution of strategies such as promoting open communication between the site and sponsor/CRO, stressing the importance of a single point of contact (SPOC) from feasibility to contracts, and following unified SOP/Quality Guidelines across a network is easy to write but much more difficult to execute. Learn invaluable real-life examples of successes for each of these strategies to be realized.

Brandi Bonner, MSc
Manager, Clinical Operations, Covance

Steve Clemons, MSN, FNP-BC
VP Clinical Operations, VitaLink

Kenneth Somberg
Founder & CMO, Somberg Consulting

Jill Johnston
President, WCG Clinical Service Organization

Secrets & Realities to Survive an FDA Inspection

This workshop will start with a mock inspection of a clinical site to focus the discussion on the inspectional process. Following the inspection, there will be a discussion of preparing for a FDA clinical inspection. Questions that will be discussed include: What can a clinical site do to prepare? What standard operating procedures should the site have in place? What does the employee training cover? Is there an internal audit process? How does the site staff interaction with the Investigator? This dynamic interactive session will arm you with the knowledge and secrets to survive your next audit.

Deena Bernstein, MHS
VP, Site Services, Qcare

Patrick McLaughlin
CEO, Anaheim Clinical Trials

Vivienne van de Walle, MD, PhD, CPI, FAPRC
Director , PT&R

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

To Become a Rescue Site or Not? Sorting Out the Challenges and Opportunities to Make an Informed Decision

To come to the rescue of a troubled study can be rewarding and ego-boosting experience. Knowing that you played a critical role as a site who can contribute to enrollment, quality data and answering the all-important research questions can be exhilarating and enhance your standing in the eyes of a sponsor or CRO. On the flip side, participating in a challenging trial where the fist (second or third!) batch of sites are struggling can lead to headaches, lost revenue and potentially a black mark against your site’s reputation.

This interactive program will explore the “who, what, where, when, why, how” of the decision-making considerations that all sites should undertake when being approached about becoming an add-on site. Participants will be able to compare and contrast their approaches and best practices with each other as well against as the results of a recent survey conducted by the facilitator.

Beth Harper, BS, MBA
President, Clinical Performance Partners

Location: See Program for Room Location Date: October 6, 2017 Time: 1:30 pm - 3:30 pm