Master Workshops

Expand Your Summit Experience. Attend a Master Workshop on Friday, October 9.

Master Workshops are offered in three sessions. Master workshops are two-hour interactive sessions led by industry experts designed to provide attendees with valuable take-aways pertaining to a range of relevant clinical research topics.
 
Each session is $165 for SCRS Members and $195 for Non-Members in addition to your Summit registration.

 

Session ISession IISession III

Session I • 8:00 am - 10:00 am

The Nitty-Gritty… How Sites Can Be More Indemnification Savvy


Indemnification language is one of the least understood and least negotiated provisions in a clinical trial agreement. All too often, sites are accepting minimal indemnification coverage in their contract agreements, and have not requested certain important elements. This workshop will specifically cover the important elements of the indemnification provision in clinical trial agreements. The workshop leaders will dissect the indemnification provision and will review:
  1. The purposes of indemnification

  2. The legal meaning of terms contained in indemnification

  3. The elements of indemnification and how they apply to sites

  4. Cross-indemnification

  5. Special indemnification considerations when a CRO is involved

  6. When and why it may be important to accept the sponsor’s language without negotiation

  7. Recent claims and litigation where the indemnification language was or could be triggered
    Workshop participants will come away with a better understanding of how to assess and negotiate indemnification language in clinical trial agreements. We will provide suggested indemnification contract language along with the reasoning and justification for the language.

    Objectives
    1. Understand how to read and dissect indemnification language

    2. Explore the various types and meanings of indemnification and examples of special considerations that sites can use in their own negotiations of clinical trial agreements

    3. Review how indemnification issues can arise in the context of litigation through a review of several case examples
Presenters
Molly G. Huggins

Molly G. Huggins, JD, MHA

Partner

Huggins & Zuiker, LLP

 
Erin Zuiker

Erin Zuiker, JD, MPH

Partner

Huggins & Zuiker LLP



A Good Start is Half the Battle: Streamlining the Feasibility Process with Tips, Tools and Efficiencies


In the past, sites could set up a trial budget by simply looking at the study flowchart. Now, however, this only provides limited information. In this workshop, attendees will learn to how to obtain better cost insight from sponsors/CROs, which can lead to greater transparency and allow for fair budget negotiations. This dynamic workshop will explore tools that can help sites improve feasibility and study start-up processes, and most importantly, enable sites to cover costs. Attendees will understand how to spend less time reviewing site infrastructure, equipment, and staff training records with monitors, and spend more valuable visit time focused on the most critical element: the protocol. Methods to get sponsors/CROs to comply with site requests and complete documents prior to pre-screening visits will be reviewed, so that your time spent with monitors is efficient and cost effective.

Objectives
  1. Examine tools to lead to greater transparency and allow for fair budget negotiations with sponsors

  2. Streamline study start-up with tips to drive trial budget negotiations and meetings to success
Presenters
“Vivienne

Vivienne van de Walle

Director & Owner

PT&R

 
Peter Kuijpers

Peter Kuijpers
Co-founder

PT&R



Silver Bullets to Successful Recruitment & Budgeting Today


Is recruitment a pain-point for your site? Meeting recruitment goals is one of the most difficult aspects of any clinical research study. In this interactive workshop, attendees will understand how to build a recruitment plan poised for success. Learn how to meet and exceed enrollment goals by reviewing in-office strategies, community outreach methods, and the why’s and how’s of traditional media. This workshop will additionally provide tips and tools to address challenges to patient recruitment, including how to attract vulnerable patient populations and how to retain patients. Walk away with a roadmap to successful patient recruitment- and learn how to do it all within your budget!

Objectives
  1. Understand how to optimize patient recruitment through various strategies including community outreach and social media usage

  2. Learn how to maximize your site’s budget and drive for recruitment success
Presenters
Chris Trizna

Chris Trizna
President

CSSi

 
Mike Jay

Mike Jay
Vice President, Contracts and Budgets

RxTrials



Finance 101 for Research Sites


Since the industry downturn of 2008, many sites have struggled to remain financially solvent. A combination of factors including a reduced number of trials, reduction in the number of patients per study, tighter inclusion/exclusion criteria, increased administrative tasks, and a change in therapeutic mix are making it tougher than ever to for sites to remain viable. Now, more than ever, sites need to understand the financial underpinnings of their operations, in order to make better informed business decisions. This workshop will focus on financial tools and reports the site owner/director can use to better understand their business situation and position their site for success. In addition to providing an overview of basic accounting reports, this session will focus on factors that impact a sites cash flow and provide tangible tools to be employed by managers to improve their understanding of the site’s financial health.

Objectives
  1. An increased understanding of basic accounting reports and associated financial tools to ensure accurate, timely accrual financial information on your site’s profitability

  2. Insight on the financial health of the research operations

  3. Tools to sharpen the ability to reconcile studies and potentially uncover “lost” revenue with a proactive approach for managing cash flow
Presenters
Jeb Andrews

Jeb Andrews, PhD
CEO
Clinical Trials of America

 
Pam Lowery

Pam Lowery
Director, Site Services
PFS Clinical

Session II • 10:30 am - 12:30 pm

From Listen-Listen to Win-Win: Negotiating Hotly Debated Sessions of the CTA


As a significant and frequent bottle-neck for clinical trial initiation activities, the contractual language component negotiations have been identified as a major obstacle and a delay for clinical research in Phase II to III clinical trials. This Workshop will explore 5 of the major Clinical Trial Agreement (“CTA”) clauses that cause the greatest challenges and pain points for site during the negotiation process, with a primary focus on: Indemnification, Confidentiality, and Intellectual Property.

Our esteemed panel of experts will not only share their industry perspectives, but the importance of those views as they pertain to their institutional type. The panelist will also offer considerations and examples of viable CTA language that can be used to potentially streamline negotiations and improve operational efficiencies for all sites.

Objectives
  1. Understand the 'how and why' to effectively negotiate specific CTA clauses pertaining to Indemnification, Confidentiality, and Intellectual Property

  2. Consider the various industry perspectives and remove the roadblocks that can help reduce the start-up timelines for all sites

Panelists
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Stephanie Endy
AVP Extramural Funding
North Shore-LIJ Health System


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Leann Frankel
Director of Operations
Global Contracts & Outsourcing Management
Astellas Pharma Global Development, Inc


Mike Jay

Mike Jay
Vice President, Contracts and Budgets

RxTrials

 
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Paige Niemczyk
Director of Global Site Contracting
Quintiles


David Vulcano

David Vulcano, LCSW, MBA, CIP, RAC
AVP & Responsible Executive for Clinical Research
Hospital Corporation of America


Moderator
Lillian Ser” width=

Lillian A. Ser, Esq.
Ser & Associates



Using eSource to Retain Patients and Investigators


Imagine a school where 17% of the students fail to graduate and 80% of the teachers never return for a second year of teaching. This unfortunate situation is analogous to the one facing clinical research with regard to subjects and Investigators. Tremendous resources are expended recruiting and enrolling subjects and training Investigators, yet each group suffers from shockingly high attrition rates. Participants will be introduced to eSource technologies which address this attrition. Topics to be discussed in this interactive workshop include patient engagement/compliance, eSource vs eCRF, reduction of query rates and age, increasing site productivity, and using eICF to streamline consenting. Attendees will have the unique opportunity of hands-on practice with the applications to maximize understanding.

Objectives
  1. Gain a better understanding of the technology that can help to increase productivity, patient engagement, and compliance

  2. Comprehend ways to streamline recruitment efforts and boost retention
Presenters
Doug Pierce

Doug Pierce

Co-founder & President

Clinical Ink

 
Cynthia Howard
Sr. Manager Protocol Services

Clinical Ink



New Innovations and Their Influence on Regulatory Documentation, Quality & Compliance


Is your site struggling to comply with rising regulatory requirements at the same time that clinical trial complexity is increasing? While the regulatory burden is a growing problem, until now there has been limited quantitative data on the true costs of that burden and the practical opportunities for improvement. This workshop will review the results of a Site Regulatory Survey from investigative sites, which sought to quantify the regulatory burden and identify solutions. An SCRS-member site will provide an interactive case study on the implementation of electronic regulatory binders to manage the regulatory burden and foster compliance. Participants will review the key best practices and must-have features for acceptance of electronic regulatory binders with sponsors, monitors, FDA auditors and staff. This interactive workshop will provide critical insights into how sites can maintain all of their regulatory processes and binders in a truly paperless manner as well as identify the corresponding return on investment.

Objectives
  1. Gain an understanding of how to efficiently comply with increasing regulatory requirements through the implementation of electronic regulatory binders

  2. Review key best practices for acceptance of electronic regulatory binders

  3. Explore how a truly paperless approach can deliver an fundemental return on investment
Presenters
Rick Arlow

Rick Arlow
CEO
Complion


 
Cristina Ferrazzano-Yaussy

Cristina Ferrazzano-Yaussy

Vice President, Product and Customer Success

Complion

Jill Heinz

Jill Heinz, MHS, CCRP
Owner/ Clinical Research Site Manager
Treasure Valley Clinical Research, LLC
Injury Care Research, LLC



Cornerstones of Success: Building your Business Development and Patient Recruitment


All sites would agree that having more studies, coupled with an abundance of enrolled patients, is a recipe for ensuring success. However, it is very rare that we hear about a site that has “plenty of studies” or “more than enough patients.”

Frequently, sites are on a quest to improve upon these areas. How do successful sites accomplish this mission? What are the essential building blocks that sites need to achieve success in these two key areas? What kind of infrastructure and resources are needed at a site to support these vital functions? In addition, is there more than one way to achieve success in these cornerstone areas?

The saying, one size fits all, does not apply to the site world. Sites today are using various techniques to meet their business development and patient recruitment needs. Whether it’s hiring a designated in house business development person or hiring an outside patient recruitment firm to increase randomizations, today’s sites are proactive, calculated, and creative when planning for their upcoming trial needs. Sites are becoming more resourceful and savvy when it comes to their business development and recruitment requirements.

In this interactive workshop, join industry leaders from experienced sites as they share their perspectives, experiences, and results on the value of insourcing and outsourcing the essential cornerstones of business development and patient recruitment. This workshop will highlight a panel of experts from the site world, who will present unique situations at their site and how they overcome challenges and achieve success. This is a must attend workshop for any site who would like to improve upon these areas or is thinking of creating and/or expanding these functions within their organization.

Objectives
  1. Performing an internal self-assessment and how to determine if in-sourcing vs outsourcing is right for your site

  2. How to identify and vet vendors who would complement and work well with your site

  3. Identifying successful insourcing and outsourcing practices for Business Development and Patient recruitment
Panelists
Anne-Marie Baughn” width=

Anne-Marie Baughn, RN, MSN
Director, Business Development
RxTrials


Eric Hanson

Eric Hanson
President
Allied Clinical Research

 
Donna Percy” width=

Donna Percy, RN, BSN, CCRC
Vice President
Sterling Research Group


Misty Sturges” width=

Misty Sturges
Senior Projects Manager
Renstar Medical Research

Katie Mostek” width=

Katie Mostek
Clinical Director of Cardiovascular Research
Michigan CardioVascular Institute

Moderator
Yvonne McCracken

Yvonne McCracken, MPH
Clinical Operations & Compliance
RxTrials

Session III • 1:30 pm - 3:30 pm

Be in the Know...Insiders Guide to Faster Site Activation and Cash Flow


The benefits of a streamlined activation process translate directly into the need for more timely payments from sponsors and CROs. In this hands-on workshop, sites will learn best practices to streamline the activation process and minimize payment delays from sponsors and CROs. Attendees will work through a typical site activation package as workshop leaders identify common mistakes, tips, and best practices for completing these documents efficiently and accurately. There will be an emphasis placed on the Clinical Trial Agreement (CTA) to further the understanding of investigator budget and payment schedule development. Attendees will learn the impact fair market value (FMV) guidelines have on the budget they are negotiating, and develop a better understanding of key CTA clauses. Attendees will learn how to breakdown a payment schedule and also obtain tips on what can be done to support the process, so sponsors and CROs have all the information they need to expedite your payment without delay.

Objectives
  1. Acquire realistic expectations and understand the critical components for better, more timely payments from sponsors and CROs

  2. Benefit from tips and tools that can improve the site activation process, decrease delays and increase cash flow
Presenters
Becky Arch

Becky Arch

Contract Manager

DrugDev SiteStart

 
“Kevin

Kevin Williams
Vice President

DrugDev



21st Century Cures Act and Its Impact on the Sites


The 21st Century Cures Act has been in development for over a year and once enacted will have a significant impact on the way we conduct clinical research. From the conduct of clinical trials to data research, there is something in this that will affect you and your sponsors. This dynamic workshop will comprehensively explore the initiative, providing critical background information and a thorough outline of how the sites will be implicated. Attendees will understand how to smoothly navigate the changes this Act can potentially exercise on the conduct of clinical research.

Objectives
  1. Learn how this Act will affect new treatments and therapies that will not make the necessary advances without the increased funding and timely improvements to our research ecosystem

  2. Find out how legislation could potentially create significant opportunities for drug and device makers and new hope for patients
Presenter
David Vulcano

David Vulcano, LCSW, MBA, CIP, RAC
AVP & Responsible Executive for Clinical Research
Hospital Corporation of America



Don’t be Left in the Dark: Mitigate Your Risk by Uncovering Hidden Exposures and Ensuring Protection


Understanding your sites insurance policy can be complicated, and knowing what is covered OR not covered, might surprise you. Explore new and emerging risks and discover what your site needs to be properly covered and fully protected.

This Workshop will focus on the individual insurance coverages associated with Clinical Research Sites/CRO and Sponsors. Walk away with a broader knowledge of what are the different contractual obligations each faces and how are these insured. Be enlightened by the new and emerging risks that these organizations face today and what lies in store for the future.

Objectives
  1. Better understand your sites insurance policy by learning what is covered and NOT covered and the associated contractual obligations

  2. Learn more about how to protect your site against cyber liability and proper coverage in case your patient data is hacked!
Presenters
Michael Yon” width=

Michael Yon
Vice President
Hylant

 
Nathan O’Tool

Nathan O’Tool, JD
Vice President, Casualty Broker
Swett & Crawford



Implementing New Best Practices in Regulatory Compliance


Ever wonder if there might be a better way to manage regulatory compliance compared to the way it has always been done? In this interactive workshop led by experts and real sites, attendees will whiteboard how to implement several best practices to gain big improvements in regulatory compliance and efficiency, including:
  • Creation and implementation of a standardized regulatory process and binder for every study

  • Centralization of common regulatory processes and documents across all studies

  • Easy-to-implement ways to start quantifying key operational metrics and benchmark performance

Workshop attendees will receive fresh ideas from years of real world experience and take away helpful resources including tools, operational benchmarks and case studies. This informative workshop will explore several practical and actionable improvement opportunities that sites can start implementing right away. This workshop will provide additional detail into improvement opportunities mentioned in the earlier workshop ‘New Innovations and their Influence on Regulatory Documentation, Quality & Compliance.’ However attendance in the earlier session is NOT required as the information discussed will be applicable and relevant for all sites.
Presenters
Rick Arlow

Rick Arlow
CEO
Complion

 
Cristina Ferrazzano-Yaussy

Cristina Ferrazzano-Yaussy

Vice President, Product and Customer Success

Complion

Jill Heinz

Jill Heinz, MHS, CCRP
Owner/ Clinical Research Site Manager
Treasure Valley Clinical Research, LLC
Injury Care Research, LLC

 

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