10 things to consider when building a ctms business case
Post on 19-Oct-2014
359 Views
Preview:
DESCRIPTION
TRANSCRIPT
10 Things to Consider When Building a CTMS Business Case
Param Singh, Director of Clinical Trial Management SolutionsLife Sciences Business Unit
facebook.com/perficient twitter.com/perficient_LSlinkedin.com/company/perficient
Welcome & Introduction
Param SinghDirector of Clinical Trial Management SolutionsLife Sciences, Perficient
• CTMS practice head since 2008– Leads the team that implements, supports, enhances and
integrates Oracle’s CTMS solution
• Extensive Siebel CTMS implementation experience– 14+ years of experience implementing Siebel CTMS
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel CTMS
Perficient is a leading information technology consulting firm serving clients throughout
North America and Europe.
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.
About Perficient
• Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue ~$373 million
• Major market locations throughout North America• Atlanta, Boston, Charlotte, Chicago, Cincinnati, Cleveland,
Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Los Angeles, Minneapolis, New Orleans, New York City, Northern California, Philadelphia, Southern California, St. Louis, Toronto and Washington, D.C.
• Global delivery centers in China, Europe and India
• >2,100 colleagues
• Dedicated solution practices
• ~85% repeat business rate
• Alliance partnerships with major technology vendors
• Multiple vendor/industry technology and growth awards
Perficient Profile
BUSINESS SOLUTIONSBusiness IntelligenceBusiness Process ManagementCustomer Experience and CRMEnterprise Performance ManagementEnterprise Resource PlanningExperience Design (XD)Management Consulting
TECHNOLOGY SOLUTIONSBusiness Integration/SOACloud ServicesCommerceContent ManagementCustom Application DevelopmentEducationInformation ManagementMobile PlatformsPlatform IntegrationPortal & Social
Our Solutions Expertise
Life SciencesPr
actic
es /
Solu
tions
ImplementationMigration
Integration
ValidationConsultingUpgrades
Managed ServicesApplication Development
Private Cloud Hosting
Application SupportSub-licensingStudy Setup
Services
Deep Clinical and Pharmacovigilance Applications Expertise
Clinical TrialManagement
Clinical Trial Planning and BudgetingOracle ClearTrial
CTMSOracle Siebel CTMS / ASCEND
Mobile CRA
Clinical Data Management & Electronic Data Capture
CDMSOracle Clinical
Electronic Data CaptureOracle Remote Data Capture
Oracle InForm
Medical CodingOracle Thesaurus Management System
Safety &Pharmacovigilance
Adverse Event ReportingOracle Argus Safety Suite
Oracle AERS / Empirica TraceAxway Synchrony Gateway
Signal ManagementOracle Empirica Signal/Topics
Medical CodingOracle Thesaurus Management System
Clinical DataWarehousing & Analytics
Clinical Data WarehousingOracle Life Sciences Data Hub
Clinical Data AnalyticsOracle Clinical Development Analytics
JReview
Data Review and CleansingOracle Data Management Workbench
Clients
Welcome & Introductions
CTMS Practice Services
ImplementationManage implementations of Siebel CTMS/ASCEND and Mobile CRA.
IntegrationBuild interfaces between Siebel CTMS and other clinical and safety systems.
TrainingDevelop and/or deliver standard and custom training classes and materials.
Process GuidanceProvide insight, advice and solutions for specific CTMS issues based on industry best practices.
Today’s Agenda
Time (ET) Topic11:00‐11:05 Welcome and Introduction11:05‐11:30 Count Down of Top 10 Things to
Consider When Building a CTMS Business Case
11:30‐11:45 Live Demonstration of 2 Features, Voted on by You
11:45‐12:00 Q&A
Consideration #10
Simpler Maintenance
Maintain one commercial system, usually with support from the vendor, rather than multiple spreadsheets and/or home-grown databases
Consideration #10: Why?
• Minimal duplicate data entry and error resolution• No confusion about the stored location or most current
version• No need to maintain expertise in house; rely on
vendor– Vendor supplies updates, patches and bug fixes
• Hosting makes it even simpler; no need to maintain IT infrastructure
Consideration #9
Centralized Investigator Database
Store past, present and future investigator information in a central location that can be queried during site selection
Consideration #9: Why?
• One master record with multiple read-only “associations”– People, organizations and addresses are stored
separately and then associated to one another as appropriate
• Centralized maintenance = cleaner data• Can capture additional metadata from
standardized dropdown lists• Easier to query
Consideration #8
Transparent Financial Tracking
Monitor planned costs vs. actual spend vs. outstanding balances for investigators, sites, sponsors and vendors
Consideration #8: Why?
• Investigator payments, IRB fees, vendor expenses, etc. in one place provides a comprehensive picture
• Enforces business rules and SOX compliance through payment statuses that can only be updated by authorized users
• Helps to identify potential cost savings and to plan better for future trials
Consideration #7
Streamlined Document Tracking
Create standardized lists of documents to be collected over the course of various types of trials, and track standardized dates and other information against those lists
Consideration #7: Why?
• Enforces standardization and consistency in the information gathered and the method for gathering it
• Allows users to update multiple document records and/or fields simultaneously
• Enables quick identification of documents that are still outstanding, expired, about to expire, etc.
Consideration #6
Increased Recruitment Visibility
Track subject enrollment across studies and clinical programs against planned targets
Consideration #6: Why?
• Identify high- vs. low-performing investigators• Learn which sites are experiencing the greatest
number of screen failures and early terminations and why
• Capture metrics on planned vs. actual recruitment• Accurately plan monitoring resources
Consideration #5
Ability to Integrate
Streamline processes even further through automated interfaces with other clinical and safety systems
Consideration #5: Why?
• One “source” system for each kind of clinical data• Fewer data entry/maintenance resources needed• Less data investigation and correction needed• No need to log into multiple systems to find answers• Processes are completed consistently and quickly
Consideration #4
Greater Compliance
Adhere to regulatory requirements and guidelines through user access controls, enforced processes, and behind-the-scenes tracking, such as audit trails
Consideration #4: Why?
• Much easier to validate and keep validated/controlled than spreadsheets
• Much easier to control access: system as a whole and specific records
• Fewer deviations• Greater data integrity• Smoother audits
Consideration #3
Robust Reporting
Answer questions quickly and easily with ad hoc and canned reports that query one centralized database
Consideration #3: Why?
• Stores historical and current data• Stores ALL clinical trial data, from subject
recruitment to vendor payments to investigator information
• Offers high level and detailed reporting capabilities• Provides access to real-time data, especially with
integrations; no more out-dated reports
Consideration #2
Informed Decision-Making
Identify trends and inconsistencies across investigators, trials and business units
Consideration #2: Why?
• Real-time, comprehensive data enables nimble, smart decision-making
• Identify strengths and weaknesses in PIs, vendors, and even your own organization
• Identify areas of risk and put processes in place to mitigate
• Make changes to current trials and plan better for future trials
Consideration #1
Scalable GrowthIncrease the number and size of the trials you manage with fewer additional resources
Consideration #1: Why?
• No organization can afford to spend exponentially to grow exponentially
• Scalable software solutions are the answer• CTMS consolidates and streamlines subject
tracking, investigator payments, document tracking, financial tracking, site monitoring, and more, allowing you to manage more and larger trials with less
Top 10 Considerations
10. Simpler Maintenance9. Centralized Investigator Database
8. Transparent Financial Tracking7. Streamlined Document Tracking6. Increased Recruitment Visibility
5. Ability to Integrate4. Greater Compliance
3. Robust Reporting2. Informed Decision-Making
1. Scalable Growth
Siebel Clinical ASCEND
31
www.facebook.com/perficientwww.perficient.com
www.twitter.com/perficient_LS
Thank You!For more information, please contact:
Param.Singh@perficient.comLifeSciencesInfo@perficient.com (Sales)
+44 (0) 1865 910200 (U.K. Sales)+1 877 654 0033 (U.S. Sales)
top related