The Real Cost of Clinical Studies: Understanding How Much a Clinical Study Will Cost

Tune in to learn from industry experts about the many factors that drive the cost of a clinical study so you can accurately budget and plan for this key investment. Learn tips and tricks for a successful study – including early consideration of reimbursement strategy – to set your product up for commercial success.

The speakers for this webinar were Abigail Allen and Michael Anselmo from MCRA.

About Michael Anselmo

Mr Anselmo brings more than 15 years of experience supporting a variety of stakeholders in the healthcare world and extensive knowledge of the medical technology/device, pharmaceutical, digital health, behavioural health, and health insurance industries. As the Vice President and Head of the Reimbursement, Health Economics and Market Access, Mr Anselmo’s primary focus is to lead and grow his division by ensuring clients have access to the experts and resources required to solve their economic problems, secure reimbursement, and advance their businesses. While Mr Anselmo has specialization in health economics, healthcare finance and commercialization, he has successfully navigated all aspects of coding and coverage processes. Prior to joining MCRA in October 2022, Mr Anselmo served as the Vice President of Healthcare Economics at Amwell, having been part of their acquisition of SilverCloud Health, where he served as the head of their global Health Economics function supporting efforts to expand product adoption and access.

About Abigail Allen

Ms Allen has 18 years of experience in clinical research, including 13 at MCRA, where she provides management and oversight for all CRO clients. She provides strategies to clients to approach their unique clinical data collection needs efficiently and cost-effectively. In addition, Ms Allen assists clients with all types of clinical studies —from pilot to post-marketing—in a vast array of therapies supported at MCRA. She oversees a team of approximately 50 employees, who support 30+ clinical trials at any given time. Before joining MCRA, Ms Allen was a Clinical Manager at Spinal Motion, where she worked closely with her sites and the company to submit two PMAs to FDA.

About MCRA

MCRA is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client’s industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopaedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anaesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. MCRA places particular emphasis on its expertise in working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.