the top 5 ctms enhancements you can make
TRANSCRIPT
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The Top 5 CTMS Enhancements You Can Make
Param Singh, Director of Clinical Trial Management Solutions, Life Sciences, Perficient
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ABOUT PERFICIENT
Perficient is a leading information
technology consulting firm serving
clients throughout North America.
We help clients implement business-driven technology
solutions that integrate business processes, improve
worker productivity, increase customer loyalty and create
a more agile enterprise to better respond to new
business opportunities.
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Founded in 1997
Public, NASDAQ: PRFT
2014 revenue $456 million
Major market locations:
Allentown, Atlanta, Ann Arbor, Boston, Charlotte,
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
>2,600 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards
PERFICIENT PROFILE
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Business Process Management
Customer Relationship Management
Enterprise Performance Management
Enterprise Information Solutions
Enterprise Resource Planning
Experience Design
Portal / Collaboration
Content Management
Information Management
Mobile
BU
SIN
ES
S S
OL
UT
ION
S
50
+ P
AR
TN
ER
S
Safety / PV
Clinical Data Management
Electronic Data Capture
Medical Coding
Clinical Data Warehousing
Clinical Data Analytics
Clinical Trial Management
Healthcare Data Warehousing
Healthcare Analytics
CL
INIC
AL / H
EA
LT
HC
AR
E IT
Consulting
Implementation
Integration
Migration
Upgrade
Managed Services
Private Cloud Hosting
Validation
Study Setup
Project Management
Application Development
Software Licensing
Application Support
Staff Augmentation
Training
SE
RV
ICE
S
OUR SOLUTIONS PORTFOLIO
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WELCOME & INTRODUCTION
Param SinghDirector of Clinical Trial Management Solutions
Life Sciences, Perficient
CTMS practice lead since 2008
– Leads the team that implements, supports, enhances, and integrates Siebel Clinical
Extensive Siebel Clinical implementation experience
– 15+ years of experience implementing Siebel Clinical
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for
Siebel Clinical
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AGENDA
Topic
Welcome and Introduction
Investigational Product Tracking
Electronic Signatures for Trip Reports
Protocol Progress
Protocol Expenses
Site Selection
Q&A
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CTMS SERVICES
Implementation
Manage implementations of Siebel
CTMS/ASCEND.
Integration
Build interfaces between Siebel CTMS and
other clinical and safety systems.
Training
Develop and/or deliver standard and custom
training classes and materials.
Process Guidance
Provide insight, advice and solutions for
specific CTMS issues based on industry
best practices.
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# 1: INVESTIGATIONAL PRODUCT TRACKING
• Manage and schedule shipments from manufacturer to depots or directly to sites
Manufacturer
• Store product until ready to ship to site
Depot• Receive
shipment, record quantities received, used, spoiled, destroyed, etc.
Site
• Send remaining product to sponsor for destruction
Sponsor
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# 1: INVESTIGATIONAL PRODUCT TRACKING
Setup
– Create new screens & views to track
• Manufacturer & depot
• Inventory transactions that occur between the depot and site
• Inventory levels at each depot and site
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# 1: INVESTIGATIONAL PRODUCT TRACKING
How It Works
– Create manufacturer and depot records
• Record outbound transactions under manufacturer or depot as they occur
• Track inventory information for depots and sites, such as dates, number of units
received, and number of units destroyed
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# 1: INVESTIGATIONAL PRODUCT TRACKING
Pros
– Robust inventory tracking at depot and site level
– Increased inventory level visibility at depot and site
– Optimal querying and reporting capability
– Complete traceability
Cons
– More effort involved to implement
– Not ideal for tracking ancillary supplies
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INVESTIGATIONAL PRODUCT TRACKING
DEMO
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#2: ELECTRONIC SIGNATURES FOR TRIP REPORTS
Paper Process Challenges for Trip Reports
• Completion of the trip report is not centralized
• Submission of trip report for review occurs outside of an electronic system
• Versions and iterations of trip reports get lost
• Review of trip reports occur outside of an electronic system
• Final version of trip report is routed manually for signature
• Paper copy is then scanned and archived
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#2: ELECTRONIC SIGNATURES FOR TRIP REPORTS
Approval Options
• Ink signatures
• Re-authentication for status changes
• Visible audit trail of status changes
More Conservative Less Conservative
Visible audit trailRe-authentication
21 CFR Part 11 Interpretation
Ink
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ELECTRONIC SIGNATURES FOR TRIP REPORTS
DEMO
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#3: PROTOCOL PROGRESS
Commonly Requested CTMS Metrics
• Metrics to capture and track clinical information at multiple levels (protocol, region, and
country level)
• Metrics to monitor the project status and benchmark it against performance milestones,
critical events, and budgeted costs
• Subject status and enrollment rates plotted for sites, regions, and protocols
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#3: PROTOCOL PROGRESS
Additional Metrics Available via Configuration
• Study dashboard / protocol summary
– High-level view of progress of all studies
• Protocol name, status, phase, etc.
– Planned vs. actual
• Subject forecasting: # screened, # enrolled, # completed, etc.
• Site progress: # initiated, # active, # completed, etc.
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#3: PROTOCOL PROGRESS
• Study dashboard / protocol summary (cont.)
– Key study milestone tracking
• Signed protocol
• 1st SIV
• FSFV
• LSLV
• Database lock
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#3: PROTOCOL PROGRESS
• Study dashboard / protocol summary (cont.)
– Study turnaround metrics
• Approved protocol to FPI
• Enrollment time period
• LPO to final database lock
• Final database lock to final analysis
• Final analysis to CSR
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PROTOCOL PROGRESS
DEMO
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#4: PROTOCOL EXPENSESVanilla
• No way to tell total spend in conducting a study
• Only investigator payments
Additional Needs for Finance Tracking
• Ability to budget amounts for specific types of expenses
• Ability to track actual as they are incurred
• Ability to track totals across payment types as well as grand totals of all expenses
separate from investigator payments
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PROTOCOL EXPENSES
DEMO
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#5: SITE SELECTION
Basic Attributes
• Account
– Name, Type, Location,
Address
• Contact
– Last Name, First
Name, Type, Specialty,
Address
Additional Searchable Criteria
• Categories
• Assessments
• Previous Protocols
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SITE SELECTION
DEMO
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QUESTIONS?
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