The UNC Office of Clinical Trials would like to invite members of the UNC clinical trial research community to a 6 part webinar on:

“The Hidden Costs of Conducting Clinical Trials at the Site”

You will have the opportunity to register for each session separately, to pick and choose the topics most relevant to your needs and interests.  Attendance will be capped at 50 participants per session (after which you will be waitlisted).  Each session is 1 hour long and shall be held in different locations depending on the day. 

Session Topics:

• Webinar 1: Line Items and Startup Costs (Wed 11-13-13, 2 pm in Bondurant G030)
• Webinar 2: Budgeting for Subject Recruitment (Wed 11-20-13, 2 pm in Bondurant G010)
• Webinar 3: Budgeting for Subject Activities / Total Study Budgeting (Wed 12-04-13, 2 pm in Koury Case Lecture Hall G405)
• Webinar 4: Cash Flow and Collections (Wed 12-11-13, 2 pm in Koury Case Lecture Hall G405)
• Webinar 5: Contract Language (Date, Time, Location TBD)
• Webinar 6: Negotiating with Sponsors and CRO’s (Wed 12-18-13, 2 pm in Koury Case Lecture Hal G405)

I want to make sure that it is clear that this is the Koury Case Lecture Hall in the Dentistry School and NOT the residence hall which is the more common result if you use google.

All Webinars begin at 2:00pm EST. Webinars will be given weekly on Wednesdays, beginning on 11-13-2013, ending 12-18-2013, for 6 consecutive weeks.

Course Description

This 6-part webinar series will help identify the financial management practices that can be used to ensure all costs are identified and recovered. In today’s environment of increased regulatory compliance, decreasing economics, and growing competition, investigative sites are faced with greater and more complex site management objectives. Often sites are being asked to assume more and more tasks without adequate remuneration. As a result, sites are generating modest to no operating profits as they absorb these “hidden costs” of conducting and providing quality research.

How you will benefit,

1. -Understand where the current budgeting process originated and why now is the time for change.
2. -Identify hidden costs with each study, which can account for upwards of $10,000.
3. -Recognize how poor payment terms conceal hidden costs.
4. -Gain a greater understanding of the other party’s position regarding budgetary constraints.
5. -Learn to reach mutually agreeable solutions.
6. -Determine the costs of commonly occurring procedures – the “Hidden Costs” – generally not addressed in study budgets and that negatively affect enrollment.
7. -Develop and create study budget templates to yield efficiencies and cost savings.
8. -Learn how accurately and persuasively stating your position positively impacts your outcome.
9. -Learn how to nullify the top 10 negotiation road blocks.

-Case study of the cost benefit of conducting systematic and accurate study feasibility.

-Learn what qualities (and metrics – if you want to use this word) sites and sponsor should seek in each other.

-Improve contract interpretation, including indemnification, payment terms, screen failure language and termination clauses.

-Discover fair contract language changes to reach a conclusion acceptable to all parties.

-Discuss the consequences of lack of compliance with a contract.

Presenter
Michael Jay
Vice President of Contracts
RxTrials, Inc.

Michael Jay, Vice President of Contracts at RxTrials, has successfully negotiated and executed hundreds of clinical trial contracts and is recognized in the industry for his comprehensive understanding of the financial aspects of conducting clinical trials. In his role, Michael also advises hospitals, private practices and research sites on financial and contractual operational activities. Michael is a frequent speaker at both the national and local clinical research conferences around the United States and Canada on the topic of clinical research budgeting and on all aspects of clinical trial management at the site level. He has spoken for organizations such as FDA News, ACRP, DIA, SCOPE and the Society of Research Administrators.