making the move to an enterprise clinical trial management system

Making the Move to an Enterprise CTMS for Organizations of Any Size

August 23, 2012

Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc.

Welcome & Introductions

Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc.

• CTMS practice director since 2007 – Expertise in managing all phases and styles of clinical trials

– Leads the team that implements, supports, and enhances Oracle’s LabPas and Siebel Clinical solutions

• Extensive Siebel Clinical implementation experience – 11+ years of experience implementing Siebel Clinical

– 15+ implementations

– Spearheaded the creation of the Siebel Clinical “accelerator” ASCEND

Welcome & Introductions

CTMS Practice Services

Implementations

Manage implementations of Siebel Clinical, Siebel Clinical ASCEND, and Oracle Health Sciences LabPas.

Integrations Build interfaces between Siebel Clinical or LabPas and other clinical and non-clinical systems.

Training Develop and/or deliver standard and custom training classes and materials.

Process Guidance Provide insight, advice, and solutions to specific clinical trial management issues.

Today’s Agenda

• Welcome and Introductions

• What Is an Enterprise CTMS

• Key Indicators for a CTMS

• Internal Analysis and Preparation

• CTMS Selection Checklist

• Q&A

What Is an Enterprise CTMS?

• A single clinical trial management system that can be used by multiple business units or clinical research divisions within a company – Beneficial for sponsors, CROs and academic medical centers

– Can be implemented organization-wide using a big bang approach or can be rolled out using a phased approach

• A centralized system for the management of all clinical trials – Eliminates disparate spreadsheets and databases across trials

– Provides access to clinical trial information in real-time

– Enforces consistency of administrative, operational and financial aspects of trials across an organization

Could Your Company Benefit from an Enterprise CTMS?

• Key indicators that a CTMS is needed – Rapid organizational growth

– Increased clinical trial pipeline

• Recent or planned merger of two organizations

• Increased number, size and/or complexity of trials

• Introduction or increased participation in global trials

– Increased need for real-time trial information and reporting

– Increased use of outsourcing to manage various trial activities

– Inability to compare similar trials due to disparate methods of study tracking between trials

Could Your Company Benefit from an Enterprise CTMS?

• Key indicators that a CTMS is needed (cont.) – Lack of a comprehensive investigator/site database with historical trial

participation information

– Desire to integrate trial management with other applications

• Internal customer master systems, document management systems, EDC, IVRS, CDMS, safety, financial systems

• External vendor systems

– And much more…

Internal Analysis and Preparation

• Current Trial Management Processes – Identify all divisions or business units currently performing

clinical trials

– Identify average number, size and length of on-going trials

– Review how trials are being managed within the same division and across divisions

• What types of worksheets and databases utilized?

• Are standard management processes followed?

• What documentation and reporting methods are used?

• How are investigator and site payments tracked?


• Identify Stakeholders – What groups of individuals and functional areas will be

affected by the implementation of a CTMS?

– Identify key business and IT resources for the CTMS project core team

– Document roles and responsibilities of each member of the project team

– Make sure that each team member will be able to devote the amount of time necessary to make the project successful

– Develop good communication tools


• Identify Critical Needs and System Requirements – Develop a comprehensive list of requirements for the organization’s CTMS

• Solicit input from each group of stakeholders

– Prioritize each requirement

• Create a scorecard with each requirement listed as a 1, 2 or 3

• Identify ‘Needs’ and ‘Must Haves’ vs. ‘Wants’


• Where Will the Money Come From? – Create a business case for presentation to upper management and other

stakeholders

• Cost and time justifications

• Key benefits of a CTMS

• How the CTMS will be selected

• How the CTMS will be implemented

• An estimated timeline

• Post-implementation costs

– Obtain funding approval and management buy-in before moving forward

CTMS Selection Checklist

System Identification – Become familiar with basic CTMS functionality and terminology

• Internet search, webinars

– Make a list of potential vendors and research their CTMS

• Industry recommendations, conferences

• Vendor websites, product data sheets

– Narrow down the list of vendors

• Phone conversations, remote demos, feature comparisons

– Create and distribute an RFP

– Based on responses, invite top 2-3 vendors to demo on-site

CTMS Selection Checklist

Performance – Day-to-day routine use

– Querying

– Reporting

– Large number of concurrent users

Scalability – System needs to be able to handle increased

amounts of data as the company grows

– Must be able to handle large numbers of concurrent users

Key Considerations in Choosing a CTMS

Robustness – Select a CTMS with a wide range of capabilities that supports most if not

all study management tasks

Customization Options – Is the system an out-of-the box solution or can it be customized to meet

the company’s needs?

– What types of customizations or configurations are possible?

• New fields, label changes, workflows, additional functionality, etc.

– Weigh the pros and cons of any customization

↑ customization = ↑ cost

– Affect on implementation timeline


Technical Considerations – Each CTMS vendor should be able to provide details regarding:

• Technical architecture

• Hardware and software specifications

• Database sizing

• Load balancing

• Use of server virtualization

• Performance tuning

• Server monitoring

• Database back-up and restore

• Disaster recovery


Implementation Options – On-premises

– Dedicated hosting

– Shared hosting

– SaaS

Data Migration Analysis – Determine what data (if any) will be migrated from current systems or

spreadsheets

– Need for data cleansing

– Data standardization across multiple sources

– Cost analysis (programmatic migration vs. manual entry)


Integration Options – Identify the most useful and cost effective

integrations

– Analyze integration methods

– Perform cost – benefit analysis

– Determine timing of integrations

Implementation Partner – Software vendor

– Implementation specialists


Training – Process/SOP revisions

– Application training

– Training tools

Post-Implementation Support – Phone and e-mail support

– Remote access

– Knowledge base

Enterprise CTMS Conclusions

• Key Indicators for a CTMS – Rapid organizational growth and/or increased clinical trial pipeline

– Increased need for real-time trial information, a comprehensive investigator database and the ability to compare similar trials

– Desire to integrate with other applications

• Internal Analysis and Preparation for a CTMS – Analyze current trial management processes

– Identify critical needs and system requirements

– Present business case and obtain funding

Enterprise CTMS Conclusions (cont.)

• Considerations for CTMS Selection – System identification

– Performance, scalability and robustness

– Customization options

– Technical considerations

– Implementation options

– Data migration analysis

– Integration options

– Implementation partner selection

– Training and post-implementation support

Closing

Thank you for attending!

This webinar will be posted on www.biopharm.com

within 24 hours

[email protected]

+1 877-654-0033

+44 (0) 1865 910200

making the move to an enterprise clinical trial management system

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