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)