exploring metrics in siebel clinical

Exploring Metrics in Siebel Clinical

November 29, 2012 Parambir Singh Vice President of Clinical Trial Management Solutions BioPharm Systems

Welcome & Introductions

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

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

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

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

– 25+ implementations and integrations

– Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel Clinical

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.

Agenda

• Commonly Requested Siebel Clinical Metrics

• Out-of-the-Box Metrics

• Demo: Out-of-the-Box Metrics

• Additional Metrics Available via Data Manipulation and Configuration

• Demo: Additional Metrics Available

• Add-on Tools

• Audience Input

• Summary

• Q&A

Commonly Requested Siebel Clinical 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

Categories of Out-of-the-Box Metrics

• Site metrics

• Subject metrics

• Financial metrics

Note: All metrics roll up to Site, Region, and Protocol levels

Out-of-the-Box Metrics: Site

• Planned vs. actual sites

• Key site milestone dates

– 1st site initiated

– Last site terminated

Out-of-the-Box Metrics: Subject

• Planned vs. actual subjects

• Subject enrollment statistics

• Key subject milestone dates

– 1st subject enrolled

– Last subject off study

Out-of-the-Box Metrics: Financial

• Planned vs. actual

– Paid to date

– Earned to date

Demo: Out-of-the-Box Metrics

Additional Metrics Available via Data Manipulation

• Query and export to Excel to calculate metrics

– i.e., site initiation and enrollment progress for a study

1. Query site by protocol and site status

2. Export to Excel

3. Use Excel’s COUNT function to get # of sites initiated and # of

active sites (enrolling)

4. Compare site statistics to planned site progress

Additional Metrics Available via Configuration

• Payment custom metrics

– Approval turnaround

– Total turnaround

• Site custom metrics

– Startup to IRB submission

– Startup to IRB approval

– Startup to SIV

• Site visit custom metrics

– Approval turnaround

– Submission turnaround

– Total turnaround

– Weeks since last visit

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.

– Key study milestone tracking

• Signed protocol

• 1st SIV

• FSFV

• LSLV

• Database lock

Additional Metrics Available via Configuration

• 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

Demo: Additional Metrics Available

Demo: Screenshots

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Demo: Screenshots

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Demo: Screenshots

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Add-on Tools

• Clinical Development Analytics (CDA)

– Dynamic customizable dashboard

– Prepackaged clinical metrics

– Flexible ad hoc reporting capability

Add-on Tools

• Clinical Development Analytics (CDA) (cont.)

– Study enrollment over time

– Site milestones reports

• First and latest subjects screened, enrolled, and randomized

– Comparative graphs for site progress over time

• Cumulative screening vs. enrollment

• Cumulative enrollment vs. early termination

– Clinical document cycle times report

Audience Input

• What types of study metrics does your organization track?

What types of metrics would you like to track but don’t

know how?

Program Protocol Region

Site Subject Subject Visits

Payments Documents Site Visit Reports

Contacts Accounts Protocol Deviations

Activities Follow-up Items Monitored AEs

Summary

• Out-of-the-box metrics

– Site

• Planned vs. actual sites

• Key site milestone dates

– Subject

• Planned vs. actual subjects

• Subject enrollment statistics

• Key subject milestone dates

– Financial

• Planned vs. actual

• Additional metrics

– Data Manipulation

• Query and export to Excel

– Custom Payments

• Turnaround times

– Custom Sites

• Initiation date to various

milestones

– Custom Site Visits

• Turnaround times

• Time between visits

Q&A

Contact Us / Thank you for attending!

• North America Sales Contact:

– Rod Roderick

– rroderick@biopharm.com

– +1 877 654 0033

• Europe/Middle East/Africa Sales Contact:

– Rudolf Coetzee

– rcoetzee@biopharm.com

– +44 (0) 1865 910200

• General Inquiries:

– info@biopharm.com