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Welcome & Introductions

Param Singh

Vice President of

Clinical Trial Management Solutions 5+ years with BioPharm

13+ years of experience

implementing Siebel Clinical

30+ Siebel Clinical implementations

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Todays Agenda

Topic

Clinical Trial Management Outsourcing Trend

Key Considerations for Data Sharing Methods

Discussion of Data Sharing Methods:

1. CRO Export / Sponsor Import

2. CRO Access to Sponsor CTMS

3. CRO-Sponsor CTMS IntegrationScenario-Based Analysis of Data Sharing Methods

Q&A

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Current Industry Trends

Rising costs of drug development

Average $4 billion per approved drug

Government pressure to lower health care costs One of the priorities of the Obama Administration

Increased FDA scrutiny for product safety and uniqueness

Must be unquestionably safe and significantly different

Greater demand for post-market studies Long, complex, and expensive

Competition from generics

Several expiring patents

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Largest expense in drug development process:

clinical trials

Account for nearly 70% of the total research anddevelopment costs

Most effective ways to lower costs:

1. Implement technology solutions

2. Outsource As of 2010, 50% of clinical trial activities are being

outsourced

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Total spending on CROs:

$9.8 billion in 2001

$15 billion in 2007 $24 billion in 2010

Increasingly important role of CROs results in need

for greater collaboration between sponsors and

CROs A balance that includes ongoing communication, timely

access to data by sponsors, and project updates must be

maintained in order to achieve successful relationships.

-- Frost & Sullivan Research Analyst, Rinat Ariely

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Choosing a Data Sharing Method: Key Considerations

Data Turnaround

How quickly sponsor needs clean data available to them

Resources Sponsor/CRO resources available for scrubbing and/or converting data

Sponsor resources available for training CRO users of CTMS

Budget

Human resources, software licenses, system integrations

Work Volume

Number of CROs involved, number of resources involved at each CRO,

number of studies being outsourced, complexity of studies

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Method 1: CRO Export / Sponsor Import

Data is entered into the CRO CTMS, scrubbed by the CRO, exported

from the CRO CTMS, converted to fit the sponsor CTMS

requirements, and imported into the sponsor CTMS.*

*Process takes place for each data update for each outsourced study

Data Entry inCRO CTMS

Data Scrubbing by

CRO

Export fromCRO CTMS

DataConversion

Data Import intoSponsor CTMS

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Benefits

Inexpensive

Easy to modify export/import formats

Minimal technical skills required

Low risk of sharing unclean data

Low risk of sharing confidential data

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Drawbacks

Data updates depend on clear communication between sponsor

and CRO in an often hectic environment Mostly manual process

Need personnel and time to scrub and convert data before each import

for each outsourced study

No automated data validation prior to importing Potential for large number of errors to be investigated and corrected

Data availability to sponsor can have long turnaround times

Never any real-time data in sponsor CTMS

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Method 2: CRO Access to Sponsor CTMS

Create Roles

Create user roles in sponsor CTMS

For each type of contracted resource performing data entry

CreateAccounts

Create accounts and assign roles to accounts

For each contractor; at each CRO

ProvideCredentials

Provide usernames and passwords

To each contractor; at each CRO

Direct DataEntry

Each CRO contractor enters data directly into sponsor CTMS

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Benefits

No technical skills required; only the ability to use

the sponsor CTMS No export/import necessary

No integration costs to incur

No error logs to investigate and resolve

All data is real-time in sponsor CTMS

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Drawbacks

Requires time and resources to train personnel at each CRO

Per-user license costs can be quite expensive

Increases burden on CTMS Administrators to manage user roles

and accounts

Data standards can be difficult to enforce

No opportunity for CRO to review data before it is made

available to sponsor

No error logs generated; errors must be found manually

Mistakes must be corrected in sponsors production CTMS13


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Method 3: CRO-Sponsor CTMS Integration

Sponsor defines desired:

Data points

Business rules

Sponsor CTMS integrated with each CRO CTMS

CRO CTMSs

Data entry

Integration Interface

Pre-defined data points

Business rules

Sponsor CTMS

Auto-populated

No human intervention

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Benefits

Scalable solution

No need to train CRO personnel on CTMS use; CRO resources can scaleup, scale down, or change as needed without impacting data sharing

If designed in standard format, can be used with as many CROs as desired

Saves time otherwise spent on data entry, data conversions, etc.

Ensures higher data quality across all studies and integrated CROpartners

Automatically checks for errors; sends notifications when found

Provides clean data to sponsor as quickly as desired

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Drawbacks

Can be expensive to implement

CRO and sponsor resources still required to address errors

Requires CRO agreement and cooperation

If not designed using a standard format, could lock sponsor into

using specific CROs

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Scenario-Based Analysis of Data Sharing Methods

Scenario

Superdrug is a medium-sized pharmaceutical company with two

products in the market and a handful of promising compounds inthe pipeline. They currently manage all of their clinical trials

in-house using Siebel Clinical, but they realized a few months ago

that that model will not support their anticipated growth. So they

underwent the process of identifying and qualifying CROs, and theyhave selected 3 finalists. They are now trying to decide the best

method for collecting their CTMS data from these new partners.

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Analysis of Key Considerations

Consideration Superdrugs Situation

Data Turnaround Need data within 48 hours, but prefer to have it sooner.

Resources Limited internal resources available to deliver training; not a

very tech savvy group; minimal support from IT department.

Budget Modest budget available, but required to provide air-tight

business case for every major expenditure.Work Volume All pipeline drugs are first-in-science, so upcoming trials will

be long and complex; anticipating needing intense, lengthy

support from CRO partners.

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Selected Method: CRO-Sponsor CTMS Integration

Send RFPs to 3 finalist CROs

Integration plan

Reduced rates for long-term, exclusive contracts

Include SLAs

Use best proposal to draft business case for integration

Include savings projections Emphasize scalability, efficiencies, and data quality

Once approved, choose an integration vendor who will build the

integration in a standard format that can be used with any CRO

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Q&A

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Closing

Thank you for attending!

www.biopharm.com

[email protected]

+1 877-654-0033

+44 (0) 1865 910200

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2013 ohsug - sharing ctms data between sponsors and cros

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