Sharing CTMS Data Between Sponsors and CROs

Session T3.4 September 23, 2013

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

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

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 Integration Scenario-Based Analysis of Data Sharing Methods Q&A

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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Clinical Trial Management Outsourcing Trend

Largest expense in drug development process: clinical trials
Account for nearly 70% of the total research and development costs

Most effective ways to lower costs:

1. 2. Implement technology solutions Outsource

As of 2010, 50% of clinical trial activities are being outsourced

Clinical Trial Management Outsourcing Trend

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

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.*
Data Entry in CRO CTMS Data Import into Sponsor CTMS Data Scrubbing by CRO

Data Conversion

Export from CRO CTMS

*Process takes place for each data update for each outsourced study 8

Method 1: CRO Export / Sponsor Import

Benefits Inexpensive Easy to modify export/import formats Minimal technical skills required Low risk of sharing unclean data Low risk of sharing confidential data

Method 1: CRO Export / Sponsor Import

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 Create accounts and assign roles to accounts For each contractor; at each CRO Provide usernames and passwords To each contractor; at each CRO

Create Accounts

Provide Credentials

Direct Data Entry

Each CRO contractor enters data directly into sponsor CTMS

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Method 2: CRO Access to Sponsor CTMS

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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Method 2: CRO Access to Sponsor CTMS

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 CTMS
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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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Method 3: CRO-Sponsor CTMS Integration

Benefits Scalable solution
No need to train CRO personnel on CTMS use; CRO resources can scale up, 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 CRO partners Automatically checks for errors; sends notifications when found Provides clean data to sponsor as quickly as desired
Interface schedule is determined by sponsor
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Method 3: CRO-Sponsor CTMS Integration

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 in the 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 they have 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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Scenario-Based Analysis of Data Sharing Methods

Analysis of Key Considerations
Consideration Data Turnaround Resources Budget Work Volume Superdrugs Situation Need data within 48 hours, but prefer to have it sooner. Limited internal resources available to deliver training; not a very tech savvy group; minimal support from IT department. Modest budget available, but required to provide air-tight business case for every major expenditure. 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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Scenario-Based Analysis of Data Sharing Methods

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

psingh@biopharm.com +1 877-654-0033 +44 (0) 1865 910200

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