Agenda

Day 1: wednesday, april 10

  • 8:00AM – 8:45AM: Registration and Breakfast (provided)

  • 8:45AM – 9:30AM: Introductions and Discussion

    • Get to know the speakers and attendees. Tell us what knowledge you want to gain from the workshop.

  • 9:30AM – 10:30AM: Coverage Analysis and Billing Compliance Basics: Background and Considerations for a Successful Coverage Analysis Program

    • Learn about coverage analysis development and process considerations, Medicare’s research regulations, important non-research Medicare regulations that need to be incorporated into the coverage analysis, and tips for developing institutional standards that can lead to major study start-up efficiencies

    • Real life case studies and examples will be discussed throughout the presentation

  • 10:30AM – 10:45AM: Break (snacks and refreshments provided)

  • 10:45AM – 12:00PM: Coverage Analysis and Billing Compliance Basics - Continued

    • Continue learning about important Medicare regulations and process considerations your site needs to consider when developing a coverage analysis

    • Real life case studies and examples will be discussed throughout the presentation

  • 12:00PM – 1:00PM: Lunch (provided)

  • 1:00PM – 3:00PM: Clinical Trial Contract Risk Reduction

    • Understanding clinical trial contract terms and risks can be one of the more challenging aspects of the study start-up process. This session will identify high risk contract terms and how to edit the contract to minimize these risks. Several negotiation tips will be provided in order to come to an agreement with the study sponsor as quickly as possible.

  • 3:00PM – 3:15PM: Break (refreshments provided)

  • 3:15PM – 4:15PM: Clinical Trial Contract Risk Reduction - Continued

    • Continue high risk contract terms discussion and negotiation tips.

    • Case studies and examples will be provided throughout the session.

  • 4:15PM – 4:30PM: Day 1 Wrap-Up/Q & A

    • Time to ask questions!

  • 4:30PM – 5:30PM: Networking Reception (hors d'oeuvres and drinks provided)

    • After a full day of coverage analysis and contract terms, most attendees discover they share the same challenges as all the other sites attending. Get to know the other attendees – they are a great resource for questions after the workshop!


Day 2: thursday, april 11

  • 8:00AM – 8:30AM: Breakfast (provided)

  • 8:30AM – 9:30AM: Top Ten Tips for Negotiating the Best Possible Payment Terms

    • Do you know when to invoice for screen failures when the payment terms say “the first 30% of screen fails will be reimbursed at 75% of the screening visit costs, the next 20% of screen fails will be reimbursed at 60% of the screening visit cost . . . “? Neither do we, but we do have tips on how to fix this situation. Negotiating poor payment terms can lead to confusion, financial gaps, and payment delays once the study opens. This session will provide tips on how to simplify payment terms for quick negotiation and ease of use once the study opens.

  • 9:30AM - 10:30AM: Cover Your Clinical Research Costs: Considerations for Clinical Research Budgets to Ensure You are Covering Research Costs

    • Study budgets require careful review in order to minimize financial and compliance related risks. This session will discuss internal budget development, tips to prevent compliance concerns, hidden costs, and negotiation strategies.

  • 10:30AM – 10:45AM: Break (snacks and refreshments provided)

  • 10:45AM– 11:15AM: Cover Your Clinical Research Costs: Considerations for Clinical Research Budgets to Ensure You are Covering Research Costs-Continued

    • Continue discussing study budget considerations to ensure you are covering as many study costs as possible and tips for reducing negotiation timelines

  • 11:15AM – 12:00PM: Lunch (provided)

  • 12:00PM – 1:15PM: Research Administration Questions that Keep You Up At Night

    • Everyone that works in clinical research administration have certain topics that keep them up at night. This is your chance to ask how other sites are addressing those concerns. Attendees can submit questions and topics that they want to discuss before and during the workshop. At previous workshops popular topics have included how to ensure all study documents are in alignment, investigator initiated trial considerations, consent considerations, research specific HIPAA concerns, navigating Medicare’s website, and CTMS.

  • 1:15PM – 2:00PM : Wrap-Up and Q&A