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Adventures in Technology:How Sophisticated Site Operators are Positioning their Networks for Success
Raymond Nomizu
Anthony Abey
Chris Petek
October 11, 2019
Faculty DisclosureIn compliance with ACCME Guidelines, I hereby declare:
I have financial/other relationships with the manufacturer(s) of commercial product(s) or provider(s) of commercial service(s) discussed in this educational activity.
Raymond Nomizu, Co Founder, Clinical Research IO
Anthony Abey, CEO, Alliance Clinical Network, Inc.
Christopher Petek, Research Director, The Clinical Trials Network
Agenda
Industry trends
Technology trends
Case study: Alliance Clinical Network
Case study: The Clinical Trials Network
Summary of Our Convictions
Interventional trials will continue to operate through local investigators
As trends toward complexity, accountability and consolidation continue, more research will be done through site networks pursuing standardized workflows
This trend will accelerate adoption of “clinical” technologies (eSource/ eRegulatory/eConsent) by research sites
Already, eSource / eRegulatory have become mainstream, with widespread sponsor acceptance, nearing 10% adoption by sites
Three accelerating models
Network offree-standing sites
Hub-and-spoke Integrated physician model
Network Network
Practice
Practice
Practice
Practice
Practice
Practice
Practice
What’s driving this trend?
CRO consolidation
Need for standardization
Provider consolidation
New models
Enrollment challenges
Site sideforces
Physician sideforces
Increasing number of institutional investors
4
7 8
12 12
1517
0
2
4
6
8
10
12
14
16
18
2013 or earlier 2014 2015 2016 2017 2018 2019
Number of private equity owned or venture capital backed research site networks, year-end
Source: Web searches; used original institutional investment date
Networks
AMRAltaSciencesCelerionCircuit ClinicalCompassElligoERGeStudySiteJBR
LMC MannaMeridienObjective GIPMGSynexusVelocityVitalinkWake Research
Why this will drive technology adoption
Operational efficiencies
Standardization of workflows
Centralization / Specialization
eSource / eRegulatory next wave of adoption
CTMS(back office)
eSource/eReg(clinical)
Fully integrated(patients, EMR, EDC)
90’s and 00’s Now At some point
Accelerated by consolidating growth models
The traditional network model
CenterActivity Site 1 Site 2 Site 3
Business Development
Regulatory Binders
Source Template Design
Patient Recruiting
Data Collection
Source /
Negotiate
Performed Onsite
Quality Control
EDC Entry
Financial Management
Light support Local
Performed Onsite
Performed Onsite
Performed Onsite
Activity Entry
Traveling QC
Invoice /
Reconcile
Performed Onsite
The newer network model
CenterActivity Site 1 Site 2 Site 3
Business Development
Regulatory Binders
Source Template Design
Patient Recruiting
Data Collection
Source /
Negotiate
Quality Control
EDC Entry
Financial Management Centralized
Centralized
Centralized
Centralized
Centralized
Local recruiting
Performed Onsite (with guardrails)
Centralized
eSource / eRegulatory adoption ~10%+
Recruiting
Scheduling
Finance
eRegulatory
eSource
Solution adoption by workflow (%)
14
12
40
27
20
13
39
62
5
60
27
18
73
83
0
0
Industry specificEMRGeneral softwarePaper based
Source: CRIO survey of sites; likely some over-statement due to self-selection bias
More commercial vendors in research space
0
5
10
15
20
25
30
2010 2011 2012 2013 2014 2015 2016 2017 2018
eSource
eREG
Stipend
CTMS
Number of commercial software solutions for sitesBy category, by year
Source: Web searches
New players adopting eSource – NOT partners’ EHR
FDA auditors have accepted eSource/eReg
“At the very end, the FDA inspector asked if we had validated the system. We had a whole binder prepared that included our validation test scripts, our SOP’s, our user training documentation, and documentation of part 11 compliance from the vendor.
Other than that, the FDA inspector was totally fine with our use of electronic source. He appreciated how easy it was to retrieve information quickly, and how the system clearly displays the audit trail for each data point captured.”
• Principal Investigator
Predictions
• Management organizations utilizing eSource/eRegulatory will continue to consolidate sites, with growth enabled by technology
• Not all networks will perform equally ... Some winners will emerge
• High performing independent sites will do well … Lots of exit options
• eSource/eRegulatory adoption will hit 40-50% in the next 5 years, as clinical software becomes a business necessity
• These systems will integrate with sponsor based EDC, possibly eTMF systems to create synergies
• Sites and networks utilizing eSource will start to field Phase I and small Phase II studies on their platforms … blurring line b/w “SMO” and “CRO”
Background
• In 2007, Great Lakes Medical Research (near Cleveland, OH) started as a GI-focused research site
• Later went to hub-and-spoke, with coordinators visiting nearby GI practices
• In 2018, transitioned to Clinical Trials Network, a trial management organization with multiple, single-specialty nation-wide networks
• 20 GI, going for 30
• 6 Ophtho, going for 20+
• Launching CNS
• Identified total of 10 target indications
Organizational model: Network of Networks
Center
GI
Sites
Each network has:
• Medical Director• Medical Attorney• Finance & Billing• Compliance & Auditing• Regulatory• Operations Coordinator• Data Entry Team
Critical role in BD, PI recruitment,
overall QA
We centralize all major functions
CenterActivity Site 1 Site 2
Business Development
Regulatory Binders
Source Template Design
Patient Recruiting
Data Collection
Source /
Negotiate
Quality Control
EDC Entry
Financial Management Centralized
Centralized
Centralized
Centralized
Centralized
Local recruiting
Performed Onsite (with guardrails)
Central chart
review support
Technology
TBD
eRegulatory
eSource
EMR & CTMS
eSource
eSource
CTMS integrated with eSource
Robust central management of qualityeSource template creation Centralized QC / data entry Training & oversight
Monthly audit Trends analysis Research equipment
Investigators responsible for own coordinators
Network
Investigators
Practice
Everything else
Staff
Coordinators
Practices hire, fund own CRC’s
First coordinator typically a trusted clinical team member
Network provides support for first “real” hire (dedicated CRC)
Profit sharing critical motivator
• Investigators participate in network success based on revenue contribution
• Creates friendly competition andincentive to refer high performers in
• Poor-performing investigators dropped
Background
• Alliance Clinical Network, consisting of • Hope Clinical Research, Canoga Park, CA
• Excel Clinical Research, Las Vegas, NV
• 25,000+ patient database and 10+ person recruitment team across the two
• 40 enrolling studies across the two
• Multi-therapeutic
• Currently expanding to more sites
We centralize all functions except EDC
CenterActivity Site 1 Site 2
Business Development
Regulatory Binders
Source Template Design
Patient Recruiting
Data Collection
Source /
Negotiate
Quality Control
EDC Entry
Financial Management Centralized
Centralized
Centralized
Centralized
Performed Onsite (with guardrails)
Centralized
Technology
Outsourced
eRegulatory
eSource
CTMS (testing offshore model)
eSource
eSource (testing offshore model)
CTMS integrated with eSource /
Outsourced
Performed Onsite (with guardrails)
We have a dual leadership model at study-level : centralized startup/QC & localized coordination
Center
Remote study manager
Lead Coordinator
Sites
• Start-up• Regulatory• Source design• Study training• QC
• Data collection• EDC entry
This is a critical position:Drives fast start-up and
reduces deviations to near-zero
Centralized, specialized recruiting workflow
LeadsAssistant Recruiter
Recruiter
Scheduler
Gather medical
info
Do pre-screen
Hand off or schedule
DNQ
Do in-person screen
CRC and recruiter CRC only
Review results
DNQ
Schedule screening
Process vs. software – iterative process
SoftwareProcess
Adapt the system to fit your process –
or adapt your process to fit the system!
What to look for in purchasing software
1. Functionality
2. Usability / Ease of use
3. Configurability
4. Architecture
5. Disaster recovery /Contingency planning
6. Technical support
7. Training and certifications
8. Documentation and SOP’s
9. Cost (relative to benefit!)
10.Efficiency / productivity(time studies)