Clinical trials are expensive. With the constraints of quality and compliance, the only way to reduce costs is to make trial operations more efficient. When study sponsors are able to automate workflows and efficiently exchange information, documents, queries, and supplies with their clinical sites, good things happen: confusion and errors are minimized, relationships with investigators and site personnel improve, and overhead costs plummet.
In this SlideShare, we discuss how organizations can use strategy, technology, and design to reduce clinical trial costs while improving quality and compliance.
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About Perficient
Perficient is the leading digital transformation
consulting firm serving Global 2000 and enterprise
customers throughout North America.
With unparalleled information technology, management consulting,
and creative capabilities, Perficient and its Perficient Digital agency
deliver vision, execution, and value with outstanding digital
experience, business optimization, and industry solutions.
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Perficient Profile
Founded in 1997
Public, NASDAQ: PRFT
2016 revenue $487 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte,
Chattanooga, Chicago, Cincinnati, Columbus, Dallas,
Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette,
Milwaukee, Minneapolis, New York City, Northern California,
Oxford (UK), Southern California, St. Louis, Toronto
Global delivery centers in China and India
Nearly 3,000 colleagues
Dedicated solution practices
~95% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards
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Today’s Presenter
Param Singh
• Director, Life Sciences
• Leads clinical operations and
connected health initiatives
• 9 years with Perficient
• 15 years in life sciences
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6. 54.2% of
investigators
complete just
one study*
*One and done: Reasons principal investigators
conduct only one FDA-regulated drug trial.
Contemporary Clinical Trial Communications,
Volume 6, June 2017, Pages 31-38.
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• The sponsor/CRO + site/investigator
relationship imperative
• Reframing our understanding of
sites/investigators as “customers”
• Customer experience (CX) methodology
• Applying the CX process to sites/investigators
• Taking the first step: customer journey mapping
• Use Case: Duke University’s PI study
• How Perficient can help
• Additional resources
Agenda
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Why the Relationship
with Sites & Investigators
Matters
• PI turnover reported @ 54.2%
• Primary complaints:
1. Workload balance @ 63.8%
2. Time requirements @ 63.4%
3. Data and safety reporting @ 56.5%
4. Dissatisfied with finance-related issues @ 46.0%
Conclusions:
• Investigator retention is a serious
and expensive issue
• Data-based insights like these help us
understand how to improve the relationship
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Reframing Sites &
Investigators as
“Customers”
• Historically, sites and investigators have been
considered sub-contractors, independent contractors,
extensions of the sponsor, maybe even partners
• In the “Age of the Customer,” it can be useful for
sponsors and CROs to reframe clinical sites as
“customers”
• Apply customer experience (CX) methodologies to
the clinical site and investigator relationship
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Gather insights and
develop a clear view of
opportunities and gaps to
be addressed
Develop vision and high
level goals by framing
opportunities, insights and
objectives
Identify key initiatives
along with operational,
technical and platform
requirements
Prioritize initiatives
based on cost, effort
and business impact to
guide implementation
Context &
Capability
Insights
Vision &
Goals
Strategy &
Experience
Modeling
Road Map &
Execution
Planning
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Execution &
Optimization
CX Strategy & Road Map Process
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Applying the CX Process
to Sites & Investigators
• Start with understanding your customer (site
personnel, especially principal investigators)
• Duke University’s study is one example (primary
research)
• Other methods:
– Ethnographic research (observe)
– Participatory studios (brainstorm together)
– Usability testing (pilot solutions)
Context &
Capability
Insights
1
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Use Case: Duke’s Study
Primary complaints:
1. Workload balance @ 63.8%
2. Time requirements @ 63.4%
3. Data and safety reporting @ 56.5%
4. Dissatisfied with finance-related issues @ 46.0%
Awareness
Discovery
Attraction
InteractionParticipation
Cultivation
Advocacy
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Use Case: Duke’s Study
• Strategy: Minimize the impact of the study on the
site’s resources, and pay sites correctly and promptly
for the work that they do.
• Possible Solutions:
• Subject recruitment via mobile apps
• Self-administered subject prescreening
via mobile apps
• Digitized informed consent
• Clinical data collection via smart devices
• Risk-based monitoring (RBM)
• Investigator portal that includes:
• Automated notifications and reminders
• Digital signatures and electronic document
submissions
• Streamlined regulatory and safety reporting
• Charts and graphs for quick visual snapshots
• Automated workflows, including payment
inquiries/claims
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How Perficient Can Help
• Connected Health: Customer relationship
tools and services
– Data collection
– Data analysis
– Strategy development
– Process design
– Technology selection
– Solution design and development
– Implementation
– Ongoing governance
– Continuous improvement
• Perficient Digital: In-house digital agency
– Strategy and planning
– Experience design
– Content studio
– Digital marketing and analytics
– Mobile and emerging technology
– Digital experience platforms
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• Incorporating Digital Technology into Clinical Trials
View On Demand
• Life Sciences is Going Digital: 30 Examples from
Industry Leaders | Download
• Debunking the Top 7 Risk-Based Monitoring Myths
Download
• Cultivating Patient-Pharma Relationships in the
Digital Era | View On Demand
• State of the Life Sciences Industry | Download
Additional Resources
• Perficient.com/SocialMedia
• Facebook.com/Perficient
• Twitter.com/Perficient_LS
• Blogs.perficient.com/LifeSciences
Editor's Notes
Welcome from Eugene
Eugene
Eugene
Eugene
Eugene turns it over to Param
Param sets the stage (we will be diving into this particular survey later in the webinar)
Since this is just a 30-minute webinar, we don’t have time for live Q&A today, but you are welcome to email me directly with questions or comments. If you don’t have time to jot down my email address right now, fear not – all attendees will receive a copy of this webinar, including the slides.