The document discusses 5 enhancements that can be made to a clinical trial management system (CTMS). They include: 1) adding investigational product tracking between manufacturers, depots, and sites; 2) implementing electronic signatures for trip reports; 3) configuring additional protocol progress metrics; 4) enhancing the ability to track and report on protocol expenses; and 5) expanding site selection search criteria. Demos are provided for some of the enhancements.

1. 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
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WELCOME & INTRODUCTION
Param Singh
Director 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 EXPENSES
Vanilla
• 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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For more information, please contact:
Param.Singh@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+1 303 570 8464 (U.S. Sales)
+44 (0) 1865 910200 (U.K. Sales)
THANK YOU
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