In this episode, you’ll learn about the world of Clinical Trial Site Networks.
There are advantages and disadvantages when it comes to being a standalone clinical trial site.
Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.
This is where site networks come in.
For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network.
To learn more about site networks, I invited Christian Burns, President of Elligo Health Research and Co-Founder of ClinX, on the show.
Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research.
Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials.
With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian’s companies have served patients and providers across thousands of research sites globally.
His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem.
A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa.
Please join me in welcoming Christian on the show.
Sponsors:
This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io.
Resource and Links Mentioned:
ClinEdge (Acquired by Elligo Health Research)
GuideStar Research (Acquired by Elligo Health Research)
University of Tampa Public Health Program
Velos (part of WIRB-Copernicous Group)
Clinical Trial Management System (CTMS)
Clinical/Contract Research Organization (CRO)
Site Management Organization (SMO)
Association of Clinical Research Professional (ACRP)
Books and Literature Mentioned:
Innovator’s Dilemma – Clayton Christensen (Amazon, Barnes & Noble)
Blink – Malcolm Gladwell (Amazon, Barnes & Noble)
The Lean Startup – Eric Ries (Amazon, Barnes & Noble)
Show Notes:
[3:57] Overview of Christian Burns’s Career in Healthcare Industry
- Found an interest for research sites when working on his Master’s in Public Health after finishing BA at Tampa
- Got a diversity of experience in different roles at a research site
- Eventually left Master’s but the process of seeing a site network grow while working there was part of the inspiration for his future businesses
- Helped him to understand the different revenue generating activities at research sites
- Roles: Lab Tech, Study Coordinator, Business Development, Website Programmer, and also worked directly under the Site Manager
[8:49] Key Performance Indicators for Site Management
- Developed a dashboard to identify about 20-25 KPIs
- Tracking: Revenue by month, revenue projected vs actual study generated revenue, study pipeline, number of studies, and study revenue.
- Also Tracked: Sales, labor cost, and labor utilization
- Tracked labor: Number of patient visits by coordinator by week
[10:49] Benchmarking Labor Costs
- Partly dependant on site and where its at in the process of research operation developments
- Early on sites may have to take more risk and spend more on labor
- 3 Phases of development
- Labor cost mechanism at Phase One
- Phase Two is when a certain level of revenue you were expecting has been reached
- Phase Three finding and reaching a desired end state for this new research business model
- 50/50 is a strong business model for margin on labor
- Labor generates twice the value expended on it: 50,000 labor spend monthly generates 100,000 monthly income
- Net Revenue is a great significant milestone
[15:04] Business Plan Phasing and Resource for Creating a Business
- 3 Phases across 3 Years business plan
- What do we want to achieve in developing and/or enhance across the research across one to several organizations
- No explicit one size fits all. Historically consulting groups have helped sites with this process
- Most important thing is not just having a business plan document but an actual mission, vision, and overall interest in developing research operations
[18:19] Organizational Structure of Christian’s Companies
- Eligo and ClinX is a portfolio of companies
- ClinEdge, BTC, GuideStar Research all report into ClinX
- ClinEdge was the first company started. BTC was started 3 years later GuideStar was an acquisition
[19:54] Organizational Mission of ClinEdge
- Unintentionally built a network of sites and research facilities by going to Investigator Meetings and Conferences
- Saw that in the time period of 2009 social media and other changes were driving change in patient recruitment and site recruitment side of research
- Initial business model was around creating innovation solutions or value loops in the clinical trial ecosystem
- Enable these developments through study operating platform, services, and study processes with the goal of getting a seat at the table with pharmaceutical companies
- Initial Service develop a list of the 20 best research sites and implementing a marketing plan
- Centralize patient recruitment, site selection, and different study operations
[27:02] Organizational Mission of BTC
- Success of ClinEdge drew a lot of interest from Sponsors but the network couldn’t keep up and they had to start declining trials
- Fear that declining too many contracts would lose Sponsor interest
- BTC was made as an additional source to provide a more a la carte type of site selection
- Initial didn’t charge companies to use BTC, but were using a network of 2000 sites to direct them to the best approach
- Tracked different metrics around site performance, PIs, coordinators, and other feasibility metrics
[29:42] Organizational Mission of GuideStar Research
- ClinEdge and BTC grew into providing pipeline, financial services, consulting, patient recruitment – doing everything at the site level other than seeing patients and having their own study coordinators
- Two business models
- Dedicated research center(s) – site set-up to only conduct clinical trials
- Clinical practices with research as separate entity or within the same entity
- Pursued the idea of purchasing a health network but ultimately the cost/deal didn’t work out
- GuideStar Research acquisition was their means of owning a site network for future research
[32:12] Sponsor Message: Veeva Site Vault (https://sites.veeva.com/.)
[33:26] Solo vs Site Networks in the United States
- Various different site network business models so you need to look at the right one when comparing these different setups
- Some networks are fully incorporated while others are more like an independently owned clinic with support organization relationships
[35:59] Explaining Site Networks and their Buisnesss Models
- Site Networks have been more popular over the years
- Even Walgreens and CVS are technically a kind of “site network”
- Owned Site Networks: Organization that owns and operates a number of research sites
- Traditional brick and mortar sites that are typically within a similar region but not always
- Centralized group within this network that is managing how these centers conduct their research most efficiently
- Partnership Streamlining Networks: Centers are owned by one organization and a separate service provider helps them to optimize their network and operations to conduct research
- Aligns with the ClinEdge model of site networks
- Partnership model
- Zero Affiliate Networks: Number of sites that meet a mission or vision of a CRO
- Aligned pipeline strategy with a CRO but not exclusive to CRO
- Virtual Site Networks: centralizing a system first approach
- Not managing day to day research operations
- Partnering across health systems to do virtual studies
[42:23] Pros and Cons of Solo Centers vs Site Networks
- Owned Site Network
- Pros:
- Full control of site to work with Sponsor
- Can implement and change quickly
- Allows for centralized service across all sites within an owned network
- More direct budget and cost controls over negotiations with Sponsors
- Pros:
- Independent Owned Sites:
- Pros
- Don’t have as much control so you don’t have as much information for decision making
- More leeway in study services. More opportunities to select, adjust, and pivot
- Potentially greater revenue opportunities
- Central systems, processes, and staff investment is powerful when you own them
- Challenges
- Hard to get investment into infrastructure to meet enrollment expectations
- Slower in decision making
- Pros
[52:02] Considering CVS and Walgreens Site Networks
- Likely to roll into a new category of site network than what we currently see across the research landscape
- May have some of the same deficits that virtual site networks have
- Lack the experienced team members that can more forward on utilization of patient access they have
[53:32] Automated Insights Workflows
- Patient Identification Channels: Advertising or through patient charts
- Allows you to present more patients with research opportunities and potentially be consented virtually
- Live person can come in to speak with them when interested
- Patient Record Identification > Pre-consent for study introduction > Send Communication about study opportunity > Questionnaire for prescreening > automatically scheduling
[58:34] Patient Recruitment and Retention Process
- Interactive patient database is ideal for all sites
- Two databases: EHR database for routine clinical patients and clinical trial database for research participants
- Advertise and community outreach helps to establish relationships with the population
[1:01:17] Sponsor Break: Slope (https://www.slopeclinical.com/.)
[1:02:18] Clinical Trial Management System (CTMS) Databases and Recommendations
- Within a CTMS you have patient records and patient identifiers by source
- Tells you how they entered the database. For example,if they came from a Facebook ad campaign
- Patients pulled in and out of database when studies end unless they’ve consented to be contacted about future studies
- CTMS can be used as a marketing automation tool to send patients relevant newsletters or recruitment materials when appropriate
- CRIO, RealTime CTMS, Clinical Conductor, Velos eResearch CTMS
[1:06:01] Advice for Starting a New Site
- Leverage technology and tools to make starting the network as efficient as possible
- Create and track performance metrics to share with Sponsors and CROs
- Can be simple and straightforward
- Develop API integrations between a CTMS and EDC at site
- Pick a CTMS system that works with your EDC
- Electronic consents are powerful for both efficiency and quality
- Helps with storage as well
- Having a multi-channel approach to marketing and patient engagement not tied to any singular study
- See if your contracts allow you to be a part of multiple site networks simultaneously
[1:13:40] Challenges Working with CROs
- CROs are integral to the research landscape
- Communication and coordination can still be challenging
- Important to have the right channel to conversing with a CRO
- Sometimes creates issues with site turnover and repeatability of study startup and management
- Maintaining Control
- Sometimes there is overlap between site networks and CROs
- Need to explain the necessity and value of your staff to Sponsors who may not understand
- Need to clearly define boundaries and responsibilities between network and CRO
[1:19:19] Strategies to Get Sponsors to Think About Site Partners Instead of Service Providers
- Project based mentality within our industry
- Showing value across multiple trials allows to build bridges to partnership
- Sometimes relationships aren’t transnational and you need to instead understand key stakeholders to refine operations and provide highest value
[1:21:45] Books that have Influenced Christian Burns
[1:27:21] Sponsor Message: Slope (https://www.slopeclinical.com/.)
Related Episodes:
Clinical Research Billing for Small to Medium Sites with Kristi Etchberger
Major Themes:
- There are a diversity of potential site network configurations. Research and clinical centers joining site networks is a trending activity with a majority of research sites now being a member of some kind of site network.
- Site networks provide an opportunity to maximize the value of research operations and optimize the overall research capacity for sites.
- As the site network trend continues to grow and expand, these networks will have to work to define their niche within the overall ecosystem of clinical trials. This means developing and defining relationships with both Sponsors and CROs
Quotes:
- “The big thing is not just creating the business plan document, but it’s actually, you know, hearing the mission and vision and overall interest of refining and building upon research.”
- “If you declined too many studies, you’re not going to have Pfizer and Abbott coming back to you to conduct, you know, all trials.”
- “The challenges these organizations are having is being able to get the investment to actually put together the infrastructure needed to meet enrollment and retention expectations for a study.”
Audience Question:
Have you worked with research sites that were a part of a site network? What were some of the values and challenges you have encountered when doing research with site networks?
