Clinical Trial Site Budgeting –Risk Mitigation or Budget Control?

Program Overview:

The obvious win-win for a budget negotiation is a sponsor who gets good, clean data and meets their timelines, and a site that covers all their costs and makes a profit. It is common for sponsors who outsource clinical trial management to a CRO to also request support for site contract and budget negotiations. These sponsors may have an overall budget for their clinical trial; however, they often defer site cost assessment as part of CRO consulting. This content will highlight clinical trial site budgeting as both a risk mitigation strategy and an approach for sponsor to standardize site costs for optimal study budget management.

Clinical trial sites might include coverage analysis as part of their due diligence in reviewing sponsor budgets. They might also flow the cost of this work to the sponsor and when multiples sites do so, sponsors may incur additional costs for work that is replicate and redundant. Sponsors who understand clinical trials cost and coverage will see value in “owning” this work product for risk mitigation, efficient site budget negotiations and “best estimate” study cost forecasting.

Agenda Topics Include:

1. Site Budgets for Risk Mitigation
   • False Claims
   • Antikickback risks
2. Site Budgets based on Coverage Analysis
   • Differentiate routine care from activities required solely for research
   • Advantages of standardized site budgets
3. Case examples of
   • Coverage Analysis “discovery” and impact on clinical trial budget
   • “Value Add” outcomes associated with cost and coverage analysis and standardized site budgets

Speakers

Wendy Schroeder, Principal Strategy Consultant – Clinical

Wendy Schroeder has been involved with research and clinical trials for more than 25 years, and has a deep understanding of medical devices including in vitro diagnostics (IVDs) and companion diagnostics (CDx). She has served as a key company stakeholder in the implementation of an in-house contract research organization (CRO) infrastructure for a commercial laboratory moving bench IVD science into clinical validation studies and launching a biorepository of blood samples with annotated clinical data. Wendy has provided research operations oversight for commercial laboratories (Caris Life Sciences, Ashion Analytics) and IVD manufacturers (VisionGate, Inc.), as well as at hospital and clinical sites. She has supported medical device product development including device risk classification, preclinical testing and design controls and clinical strategy interactions with the FDA.

Barb Mercier Leader, Clinical Research Associates 

Barb Mercier has been in the industry over 25 years focused on clinical research experience for medical devices.   The key therapeutic areas she has supported are cardiovascular class II and III devices, neurology, peripheral vascular and wound care.  Mainly working on the sponsor side throughout her career, Barb has excelled in all areas of clinical research including site start-up activities, clinical trial agreement language and budget negotiations, core lab management and data management for companies such as Boston Scientific, Medtronic, and Respicardia, Inc. She has experience on global teams across several geographies including North America, Europe and the Middle East.