Using Siebel Clinical for

Your Specific Job Function

Param Singh

Welcome & Introductions

Param Singh Vice President of Clinical Trial Management Solutions

• 10+ years of experience implementing Siebel Clinical

• Managed over a dozen Siebel Clinical implementations

Welcome & Introductions

CTMS Practice Services

Implementation Manage implementations of Siebel Clinical, whether custom builds or our out-of-the-box accelerator, ASCEND.

Integration Build interfaces between Siebel Clinical 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 CTMS issues based on industry best practices.

Today’s Agenda

Time (CDT) Topic

9:00-9:05 Welcome and Introductions

9:05-9:10 Intro to Siebel Clinical

9:10-9:15 Clinical Administrator

9:15-9:20 Clinical Document Associate

9:20-9:25 Clinical Finance

9:25-9:30 Clinical Research Associate / Monitor

9:30-9:35 Executive

9:35-9:45 Study Manager

9:45-10:00 Q&A

Intro to Siebel Clinical

Clinical Trial Management System (CTMS)

• Technology solution

• Helps to manage the administrative aspects of clinical trials

• Reduces time and cost

Oracle’s Siebel Clinical

• Robust CTMS solution

• Provides greater visibility into real-time data

• Enables informed decision-making

Intro to Siebel Clinical

Program

Protocol

Region

Site

Subject Visits

Subject

Visit

Template

Product

Contacts

Accounts

Addresses

Clinical Administrator

• Centralized study start-up tasks

– Products – Protocols

– Programs – Regions

• Centralized investigator database management

– Contacts (people)

– Accounts (organizations)

– Addresses (locations)

Clinical Administrator

• Centralized template creation

– Activity (Task) / Document

– Assessment

– Subject Visit

Clinical Document Associate

• Document tracking

– Apply and complete document templates created by Clinical Administrator, such as:

• Essential documents

• Trial Master File contents

• Country-specific documents

– For each document, track critical dates, comments, URL to the electronic copy

– Query document records to determine what is missing, what is about to expire, and so forth

Clinical Finance

• Standard payment amounts

– Define in the subject visit template (SVT) for each study, then apply to each site

• Can be based on procedure, visit, or milestone

• Site contracts

– Record CTAs and designate payees

• Site-level payment amount exceptions

– Modify payment amounts for one or more line items

• Exception amounts apply to all future subject visits

Clinical Finance

• Payment amount adjustments

– If an incorrect payment amount is found after the subject visit has been completed, correct it ad hoc

• Payment requests

– Generate according to your process or CTA terms: real-time, monthly, quarterly, etc.

• Payment details

– After paid, enter details such as check number, amount, and date

Clinical Finance

• Site advances

– Send initial or advance payments to sites

– Choose whether to recover amount over time, at the end, or not at all

• Site fees

– Reimburse travel expenses, IRB fees, and other expenses

– Define unlimited payment types to track to the level of detail you need

• Helpful for recent changes to Sunshine Act

Clinical Finance

• Financial snapshot

– More Info view displays planned and accrued site expenses for all sub-levels in hierarchy

– Track accrued expenses against contracted budgets

• Queries / Ad hoc reports

– By site, by region, by protocol, by status, by payment type, etc.

CRA / Monitor

• Site set up

– Associate contacts, accounts, and addresses

• Site maintenance

– Keep contacts up-to-date

– Track ancillary and clinical supplies

– Track documents, tasks, and general correspondence

CRA / Monitor

• Site monitoring

– Track follow-up items, protocol deviations, adverse events, CRF records

– Complete and submit trip reports

• Subject tracking

– Enter subjects

– Record informed consent

– Record subject status changes, such as early terminations

– Record completion dates for subject visits

Executive

• Birds-eye view

– Program > Explorer view displays all sub-levels of the hierarchy for each clinical program

• Metrics

– ASCEND: View turnaround times for trip reports and investigator payments

Executive

• Rollups

– All views at program level are aggregates of sub-views

– Most views at region and protocol levels are aggregates of sub-views

• Queries

– Run ad hoc reports in nearly any applet in any view

– Save them for future use

– Share them with others

Study Manager

• Subject enrollment

– See which investigators/sites are most efficient

– Monitor enrollment over time

– Project study completion at site and region levels

• Subject statistics

– Identify trends in early termination and/or screen failure reasons

– Make real-time changes, if necessary

Study Manager

• Site visits

– Add planned site visits to calendar

– Ensure visits are occurring in accordance with monitoring plan

– Review and approve/reject trip reports electronically

• Expenses

– Track accrued expenses against planned; proactively know when an amendment is needed

Key Take-Away by Role

Clinical Administrator: Set the standard.

CDA: Ensure regulatory compliance.

Clinical Finance: Exercise more control.

CRA / Monitor: Maximize your efficiency.

Executive: Get answers fast.

Study Manager: Flex your power.

Q&A

Closing

Thank you for attending!

This webinar will be posted on www.biopharm.com

within 24 hours

psingh@biopharm.com

+1 877-654-0033

+44 (0) 1865 910200