CFS Clinical and CBI continue to foster unique partnership

By Mia Burns

Technology-enabled service provider CFS Clinical will co-chair CBI’s 5th Forum on Clinical Trial Budgeting & Project Management Conference from July 17 through 18, in addition to the Pre-Conference Clinical Study Start Up Seminar on July 16. CFS will co-chair the event at the Doubletree Hotel in Philadelphia with Brenda Medina, director and global head of clinical business operations at Eisai.  However, CFS is not going to limit its experts to co-chairing. Team members are scheduled as panelists and speakers during sessions throughout the week.  Topics include “What Protocol Design, EDC Collector and Site Payments Have in Common” and “Streamlining the Contract and Negotiation Process to Avoid Study Delays.”  Also featured is a unique panel discussion exploring the often overlooked tax risks and mitigation strategies when dealing with global investigator site payments.  This session features CFS’s April Mulroney, CPA, CA, VP of Global Tax, Treasury, and Client Services, alongside experts from Ernst & Young and Shire. Associate Wed Editor Mia Burns interviewed Kevin Williams, MBA/MS, VP, corporate development & marketing, CFS Clinical.

Q: What are some of your expectations for co-chairing these events?

A: As the pioneers and leaders in our space, CFS Clinical continues to demonstrate and position itself as a thought leader as it relates to paying clinical trial investigators and managing the complex document logistics for study startup.  For this particular CBI event, the overall theme falls right in the sweet spot for our organization.  As such, taking a leadership position where we can provide guidance to the program material and highlight relevant topics with CBI is paramount to driving transformational change to the business and financial management of clinical trials.   To drive positive disruptive change and also evolve our business, our roles in conferences like these not only enable us to share our experiences but also continue to learn and commiserate with other industry leaders dealing with similar challenges in their organizations.  Moreover, the event also provides a great way for us to work with our existing clients and feature their transformational leaders and experts, like we are doing with this conference with our co-chair Brenda Medina, director and global head of clinical business operations for Eisai, Inc.

 

CFS and CBI have developed a unique partnership and continue to work together to deliver expert content to the industry.  CFS chaired last year’s inaugural Study Startup event, and now has continued and expanded its involvement with this year’s Study Startup Forum as well as the 5th Annual Clinical Trial Budgeting and Project Management Forum which CFS has participated in a variety of capacities over the last several years.

 

Q: What were some of the motivating factors that led to Ernst & Young, CFS, and Shire putting this first time panel together?

A: Since CFS Clinical has been specifically focused on investigator site payments as a core business, we have become intimately involved in understanding and navigating the intricacies of issuing payments to sites around the globe.  As CFS has scaled its global payment business, it was imperative to retain the support of leading tax experts with deep knowledge in the life science around the globe.  As such, CFS has been leveraging a positive, strategic relationship with the VAT experts from Ernst & Young for the last few years.  As a functional, strategic provider of investigator payment services to Shire, they have been benefiting from our robust services surrounding our investigator payment offering, specifically including our tax strategies for managing payments for them on their global clinical trials.

When providing input to CBI for the program, I wanted to introduce a topic that while critical, was often overlooked and had never been covered at any of the conferences we have ever attended.  Ultimately, a sound VAT management strategy for global investigator payments can save pharmaceutical sponsors millions of dollars with their clinical trial spend.

 

Q: What are some examples of overlooked tax risks and mitigation strategies when dealing with global investigator site payments?

A: One of the key factors to a keen tax strategy for investigator site payments is the clinical trial agreement (CTA).  The CTA is the source instrument which defines the details of the payments to be issued for a site’s performance on a trial.  For global clinical trials, there are often one or more entities involved in the conduct and legal representation aspects of the trial, including local sponsor subsidiaries and/or CROs.  The countries and contracting parties directly affect the rates and requirements for applying VAT on top of the investigator grant dollars.  With VAT rates ranging anywhere from 5 percent to 27 percent and global investigator grant spending exceeding $13 billion annually (IMS Health), these tax rates can significantly impact sponsors total clinical trial budgets which are already under great scrutiny and pressure.

Q: I downloaded the Clinical Study Start Up Seminar startup agenda. What are some of the components in start-up that ultimately affect the overall process?  

A: The success of a clinical trial and ability to meet timelines ultimately hinges on the ability to get enrollment-ready clinical trial sites.  However, in order for sites to be ready to begin enrolling patients, there is a series of complex logistical tasks that must be completed related to regulatory as well as business requirements to conduct a trial.  Outside of actually selecting and qualifying the site, the sponsor (or obligated CRO) must then distribute, negotiate, and collect a large set of documents, including medical licenses, CVs, informed consents as well as clinical trial agreements and budgets that will govern the relationship.   With respect to negotiating the budget with the sites, there has been much more scrutiny around them due to compliance concerns with respect to fair market value (FMV).  Moreover, the ultimate output of the financial terms of a sponsor/Health Care Provider (HCP) relationship is monetized with the issuance of payments, which now will be made publicly available beginning in 2014 with the passing of the Physician Payment Sunshine Provision of the Patient Protection and Affordable Care Act (aka “Sunshine Act” or “Open Payments”).

Q: How did you decide on which topics to cover for the sessions?

A: In terms of the sessions, CBI conducts extensive research and surveying to try and find the latest and most interesting topics to formulate the core program.  CFS, as the sponsor and co-chair, is then able to further refine and recommend sessions, such as the tax session, based on our outlook on the industry.  The session topics found in the program are a reflection of the latest industry trends based on CBIs research as well as what our clients, industry colleagues, and CFS experts are buzzing about.

Q: Will Ernst& Young, CFS, and Shire conduct this panel next year at these conferences, or is it too early to say?

A: While it is a bit early to say, given the intense scrutiny around clinical trial budgets and industry pressures to transform processes, I’m certain you will continue to hear more from us around this topic as well as other related issues as we drive industry change.  In fact, we just conducted a webinar last week on the challenges of global investigator site payments with another one of our partner organizations – the Society for Clinical Research Sites (SCRS).  As a Global Impact Partner with SCRS, we are working in concert with leaders around the industry to improve the interactions between clinical trial sponsors, CROs and research sites – with site payments being a top concern.

CFS Clinical Co-chairs CBI’s Clinical Trial Budgeting & Project Management Conference

 

Posted: July 2013

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