2013 ohsug - benefits of out-of-the-box-cda for siebel clinical

PREVIOUS NEXT PREVIOUS NEXT Oracle Health Sciences User group September 2013

Slide 1

Benefits of Out-of-the-Box CDA

for Siebel Clinical

[Session #]

[Date]

Parambir Singh Vice President, Clinical Trial Management Solutions BioPharm Systems Mike Grossman Vice President, Clinical Data Warehousing and Analytics BioPharm Systems


Slide 2

Welcome & Introductions

Param Singh

Vice President, Clinical Trial Management Solutions

BioPharm Systems, Inc.

Mike Grossman

Vice President of

Clinical Data Warehousing and Analytics

[email protected] | (210) 454-5192


Slide 3

Agenda

• Industry Trends and Challenges

• What is CDA?

• CDA Out-of-the-Box

• What are the benefits of using CDA

and SC together?

• Custom Reporting

• Live Demo

• Q&A


Slide 4

Industry Trends

• Significant Increase in Outsourcing of Trials

– Moving from one-off interactions to

partnership-based relationships

• Clinical trials are becoming increasingly complex

– More trials, more regulations, more regions, more resources

• Accurate forecasting and real time reporting

is more important than ever

– Need the ability to view and report on data in

different ways


Slide 5

Industry Trends • Need to address cost pressures and proactively reduce

patient risks on increasingly complex clinical trials.

• Companies are moving to a more efficient and holistic

approach to decision support to get more value from data

collected

• This new approach reduces overall costs and makes data

available from numerous sources.

• As a result, organizations are able to make important

decisions faster based on more accurate data.


Slide 6

Reporting Challenges with Siebel Clinical

• Limited number of out-of-the-box reports

– Provides basic information in specific areas only

– Little flexibility for end user in data displayed

• Export capability nice, but requires additional manipulation – Basic data dump

– Requires knowledgeable resource to display in logical or graphic fashion

• New reports must be developed using BI Publisher or other reporting tool

– May be time consuming, depending on the tool

– Requires design, development, validation and testing

– Requires experienced development resource


Slide 7

Oracle Health Sciences Clinical Development Analytics is a comprehensive

analytics solution that provides sponsors and CROs timely, fact-based insight

into clinical programs to make more informed business decisions, increase

R&D productivity, and develop drugs more effectively.

What is Clinical Development Analytics?

This slide courtesy Oracle Copyright © 2012, Oracle and/or its affiliates. All rights reserved.


Slide 8

CDA Warehouse & Analysis Engine

What is Clinical Development Analytics? CDA Presentation

Engine & Role-based Dashboards

Such as OC / RDC, Siebel Clinical, and third party systems

Clinical Development Users from Executives

to Sites

View progress at the organizational,

regional, study or site level

This slide courtesy Oracle Copyright © 2012, Oracle and/or its affiliates. All rights reserved.


Slide 9

CDA – Out-of-the-Box Content

Contains over 150 pre-built reports and dashboards

• Trial Management

24 pre-packaged reports

– Covering Screening and Recruitment, Retention and Document

Management

– Primary Data Source is Siebel Clinical

• Data Management

26 pre-packaged reports

– Covering both EDC and Paper processes

– Primary Data Source is Oracle Clinical / Oracle Remote Data

Capture


Slide 10

CDA – Out-of-the-Box Content (cont.)

• Data warehouse optimized for clinical trials

– Contains over 1,000 business attributes

– Attributes cover performance management metrics and

associated descriptive terms about clinical trial progress

# Subjects Enrolled, Study Name, Site, # eCRFs Approved, etc…

• Pre-built business adapters for Clinical Applications


Slide 11

CDA and Siebel Clinical


Slide 12

• Helps sponsors and CROs make more informed

business decisions

– Review and manage all clinical programs across the

organization to make key business decisions early

• Provides instant access to study and project status

metrics

– Accelerates study progress with better visibility into data

– More easily track Study, Region and Site Progress

– Identify non-performing sites and better focus resources

Benefits of Using CDA with Siebel Clinical


Slide 13

• Improves Clinical Productivity and Effectiveness

– Increase effectiveness via more focused resource optimization

– Reduce costs via greater site visibility, minimizing unnecessary

travel expenses

– Improve overall study performance by identifying non-performing

sites earlier

– Manage site performance and focus resources on most critical

sites

Benefits of Using CDA with Siebel Clinical (cont.)


Slide 14

Additional Benefits for Study Team Members

• Clinical Monitor

– How is enrollment progressing?

– What are the most common reasons for screen failure?

• Study Manager

– Which documents are outstanding, preventing site readiness?

– Which sites are taking the longest to return documents?

– Which sites are the best and worst performers?

• Program Manager

– Which regions are recruiting the most sites?


Slide 15

Custom Reporting

• Reports and dashboards can be quickly customized and

extended to meet an organization’s unique requirements

– Pick data points

– Look at results and Save

– Add Graphical Displays


Slide 16

Live Demo – CDA and Siebel Clinical


Slide 17

Q&A


Slide 18

Closing

Thank you for attending!

www.biopharm.com

[email protected]

[email protected]

+1 877-654-0033

+44 (0) 1865 910200

18


Slide 19

Presenter Bio

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

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

– Leads the team that implements, supports, enhances, and integrates Oracle’s Siebel Clinical solution

• Extensive Siebel Clinical implementation experience – 12+ years of experience implementing Siebel Clinical

– 30+ implementations and integrations

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

[email protected] | (210) 454-5192


Slide 20

Presenter Bio

Mike Grossman Vice President of Clinical Data Warehousing and Analytics BioPharm Systems, Inc.

• CDW/CDA practice lead since 2010

– Expertise in managing data for all phases and styles of clinical trials

– Leads the team that implements, supports, enhances, and integrates Oracle’s LSH and other data warehousing and analytic solutions

• Extensive Oracle Life Sciences Hub (LSH) experience

– 10 years of experience designing and developing Oracle Life Sciences Hub at Oracle

– 27 years in the industry

– 5+ years of experiencing implementing LSH at client sites

2013 ohsug - benefits of out-of-the-box-cda for siebel clinical

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