The ABCs of Clinical Trial Management Systems

The ABCs of Clinical Trial Management Systems

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

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

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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

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 Topic1:00‐1:05 Welcome and Introduction1:05‐1:15 What is a CTMS and Who Needs One1:15‐1:25 Key Functions of a CTMS1:25‐1:30 CTMS Selection Process1:30‐1:35 System Types & Implementation Options1:35‐1:45 Best Practices1:45‐2:00 Q&A

What is a CTMS?

• Web-based technology solution that centralizes the management aspects of clinical trials

• Results in streamlined business processes and reduced time and cost for most trials

• Enables informed decision-making based on real-time data

• Simplifies historical reporting

Who Needs a CTMS?

• Any sponsor organization, clinical research organization or academic medical center that:– Manages multiple clinical trials on an ongoing basis– Wants to centralize and standardize the management of

clinical trials and the associated business processes– Wants to reduce study start-up time and associated costs

while increasing efficiencies

Key Functions of a CTMS

• Investigator and Site Database– Cataloging the history and details

of all individuals and organizations associated with clinical trials

– Accelerating feasibility analyses during investigator and site selection

• Study Set-Up– Tracking essential documents– Planning for study expenses– Standardizing visit and payment schedules

Key Functions of a CTMS

• Site Management– Tracking of site budgets and investigator payments– Tracking of subject enrollment and progression – Tracking of investigational product and ancillary supplies– Tracking of protocol deviations and follow-up issues– Tracking of site visits and monitoring reports

Key Functions of a CTMS

• Subject Tracking– Tracking overall subject enrollment– Tracking individual subject visits and activities– Tracking subject status at any time

• Document Tracking– Tracking regulatory and other documents based on a study, site,

individual or company– Tracking single documents or document packages

Key Functions of a CTMS

• Financial Tracking– Monitoring expenses across a project– Tracking investigator payments based on completed activities or

milestones– Tracking pass-through expenses at the site or study level

• Reporting– Monitoring trip reports– Document tracking reports– Payment reports

Selecting a CTMS

• Requirements – Organization gathers requirements from business users, IT and

other stakeholders– Requirements are reviewed, finalized and prioritized

• Demos – Vendor RFPs are distributed and responses received– Demos are scheduled by multiple vendors– Gap analyses are performed– Short list of best-fit systems is developed

• Final Selection– Following further demos, additional requirement reviews and

detailed sales discussions

Consideration: System Types

• Standard CTMS: – Out-of-the-box system without

organization-specific customizations– Shorter implementation time, but may not meet all of the

organization’s requirements• CTMS Accelerator:

– Pre-configured version of a standard CTMS that includes commonly-requested configurations and enhanced functionality

– Can satisfy many of the organization’s key requirements without additional development

– Less time and cost than a customized system

Consideration: System Types

• Customized CTMS: – Standard or accelerator system

that is tailored to organizationspecific configurations and/or enhancements

– Implementations can be up to and over several months– Costs can be up to and over $1M, depending on the system

chosen and level of customization• Costs can be reduced by starting with an accelerator

Consideration: Implementation Options

• In-House: – Hardware and software is owned, housed and operated by the

organization and maintained by its IT department

• Hosted: – Hardware and software is housed and maintained off-site by a third

party

Consideration: Hosting Options

• Dedicated Hosting: – You own the software and the servers, but the servers are

housed/maintained by a data center• Shared Hosting:

– You own the software, but the servers are owned, housed, maintained by a data center and can be shared by others

• Cloud Computing/SaaS: – You lease the use of the software and servers

Best Practices: Selection Process

• Collect requirements from ALL stakeholders• Consider requirements beyond system functionality• Prioritize and define your evaluation scale

– Consider whether you need all requirements met immediately or whether some can wait for a future phase

Best Practices: Implementation Strategy

• “Big Bang”– All aspects of implementation

completed simultaneously• Phased

– Implementation is broken up into chunks, such as:

Basic InstallationPoint Release for 

Custom Configurations

Data Migration & Retirement of Legacy Systems

Integrations

Best Practices: Before Implementation

• Assemble your project team• Determine the tasks,

deliverables, deadlines and responsible resources

• Create a scope control plan• Design your communication plan• Begin your SOP gap analysis• Begin analyzing the

organizational structure

Best Practices: During Implementation

• Adhere to the project charter and the communication plan

• Design your rollout plan• Design your training plan• Design your support plan• Involve users early and often• Create a “data standards” document• Mandate the use of CTMS

Questions?

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