The Future of Global Clinical Trial Budgeting: A Story of a Unique Collaboration

Medidata is more than just Rave EDC, as many already know. The clinical operations solutions are cutting edge and we are always looking for innovative ways to approach the processes and technology, especially within our clinical trial budgeting and site payments solutions. Our recent research showed that an inaccurate initial budget received by the site is one of the biggest pain points within the clinical trial  budgeting process. To address this challenge, the Clinical Trial Financial Management (CTFM) R&D team is collaborating with the National Institute for Health and Care Research (NIHR) to understand and improve the frustrations sites, sponsors, and CROs face within the clinical trial budgeting cycle.

The CTFM team is specifically working with Laura Bousfield at NIHR, who leads the organization's study planning and placement support for new research. The Medidata team and Laura have a shared vision and understanding that every day a site contract gets delayed, so does a patient’s access to that trial.

About Laura

As an inherently curious person and lover of learning, science gave her answers. Laura was known in her family for asking ‘what if…’ so undergraduate and postgraduate studies in the life sciences felt like a logical path for her. That led to her first job as Research Administrator in her local Teaching Hospital. This is where she was first introduced to clinical research. She gained hands-on experience in clinical trial patient recruitment, data collection, and conducting visits.

Laura then went to work in Client Services at a Phase I Unit within a global Contract Research Organization (CRO). Looking back, this was her most formative role both in the research sector and professionally. The operations of the unit let her experience research from the initial proposal to the first participant dose through the production of the clinical study report. If science is her yin, then creativity is her yang. She is energized by making, doing, and storytelling. In her work, she channels this through presenting and sharing messages—spanning from attracting new business to shaping the way research is set up to increase patient access across the nation.

The Costing Template is Born

Laura joined the NIHR in 2011. This move fulfilled her ambition to take up a role supporting research in the NHS. She was responsible for a relatively new commercial costing template—a product born out of an independent review of UK health research funding (Cooksey Report, 2006) recommending a ‘standard costing framework.’ This framework evolved through the incorporation of user-led improvements under the direction of the multi-stakeholder Commercial Costing Reference Group, into the online interactive Costing Tool it is today. 

Connection Economy

With the NIHR being a joined-up national research system, it has huge strengths and provides a unique selling point to attract more research for patients across the country. Yet standardized approaches like the Interactive Costing Tool still rely on partnerships working between sponsors, CROs, and sites to embrace the full benefits. Site contracts always involve some level of negotiation; being clear on the starting point and the red lines from the offset will minimize the impact of this.

The common theme here is connection: According to Laura, “partnerships are critical to my role in supporting the nation’s research infrastructure because they all help create and maintain connections; the success of this system is built on the strength of our connections, like Medidata.”

Looking to the Future of Clinical Trial Budgeting

The future of global clinical trial budgeting is bright. If we’ve learned anything, communication and partnerships are key. The only way to make improvements to the process is through relationships and collaboration. The Medidata team is working on some innovative tools. Stay tuned!

Laura Bousfield will speak at the Medidata NEXT London conference on May 24th. Register here.

To find out more about how the NIHR can support the planning, placement, and performance of your study please contact: supportmystudy@nihr.ac.uk

Find out more about the interactive Costing Tool on the NIHR website.

About the Authors:

Laura Bousfield, Head of Feasibility and Start-Up, CRN National Coordinating Centre (CRNCC), NIHR Clinical Research Network (CRN)

Laura Bousfield is the Head of Feasibility and Start-up at the NIHR Clinical Research Network. Laura's role at the NIHR oversees the provision of national support to plan and place clinical research across the health and care system, which includes the interactive Costing Tool. For the last ten years, Laura has been working with commercial companies and research sites to embed and refine this national asset; facilitating partnerships working between commercial sponsors and NHS sites during study set-up with the overall aim of decreasing costing and contracting timelines.

Nicole Montgomery, Director, Product Marketing, Clinical Trial Financial Management

Nicole Montgomery is the Director of Product Marketing for the suite of clinical trial financial management products at Medidata Solutions. She has spent the last 14 years of her professional career working within the life sciences industry with a primary focus on technology and the investigator grant budgeting & payment processes. She has worked for several technology and service provider companies within the industry in a variety of roles that includes client services, operations, implementation, training, sales, and marketing. She holds a BS in Finance from Rutgers University.