10 Things to Consider When Building a CTMS Business Case

Param Singh, Director of Clinical Trial Management SolutionsLife Sciences Business Unit

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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

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We help clients implement business-driven technology solutions that integrate business

processes, improve worker productivity, increase customer loyalty and create a more agile

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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.

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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

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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)