Decentralized clinical trials

A company that provided mobile vision centers for office workers switched to supporting clinical trials during the pandemic. With normalcy returning, the company needed help to decide whether to invest in building a clinical trials business for the long term.

Background

• Client had built a strong business providing mobile vision centers for employee eye exams, competing on basis of patient convenience and clinical quality

• When the COVID-19 pandemic arrived, customers’ offices closed and Client’s business came to a halt

• Serendipitously, Client was approached by pharmaceutical companies desperate to keep clinical trials operating when traditional medical offices were shut down.

• Client successfully adapted its offering to serve clinical trials and executed multiple trials successfully.

• Some pharmaceutical sponsors expressed a willingness to continue using Client for clinical trial support post-pandemic, but this had not translated into strong bookings.

Client request

• Provide expertise and data to help Client determine whether to invest in clinical trial business for the long term.

Key issues for consulting team to address

• Market demand

  • How would the life sciences industry approach decentralized clinical trials after the pandemic?

  • How many ophthalmology trials were planned? To what extent would non-ophthalmology trials require ophthalmology endpoints?

  • Would traditional, fixed clinical trial sites view Client as a threat or potential collaborator? How would this affect trial sponsors?

  • To what extent would new demands for diversity and equity in clinical trials translate into change by trial sponsors? Would decentralized trials be viewed as a solution?

• Client capabilities

  • Did existing Client capabilities meet the needs of trial sponsors?

  • Would Client’s patient-centric approach provide an advantage for trials?

  • What was the Client’s cost position compared with traditional sites?

• Competitive landscape

  • Who else provided similar services for ophthalmology clinical trials? What value proposition did they offer?

  • Were competitors typically focused on ophthalmology or a broader array of therapeutic areas?

  • How did Client compare on key capabilities important to sponsors?

• Synergies/dyssynergies with Client’s core business

  • Would clinical trials business complement or interfere with employer eye exam model?

  • Could the same mobile vision centers be used for both businesses, or would separate infrastructure be required?

• Investment requirements

  • What investments would be needed to win?

  • Over what time frame would investment be required?

  • Would this business likely attract external capital?

Health Business Group approach

• Health Business Group worked closely with a management team --that had little prior experience with clinical trials-- to define the key questions and outline the workplan

• Compiled data on ophthalmology clinical trial market participants and market trends

• Conducted one-on-one interviews

  • Existing Client customers and additional clinical trial sponsors from the HBG network

  • Experts and competitors

• Synthesized findings

  • Created a fact base to address the questions systematically

  • Conducted workshops to discuss findings and implications

  • Made recommendations on whether and how to proceed

Outcomes

• Developed a high-level business plan for market entry

• Created an interactive tool to use with customers to quantify Client’s value proposition

• Facilitated board understanding and consensus on a topic that was outside their area of expertise