2013 ohsug - sharing ctms data between sponsors and contract research organizations

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.

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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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Today’s 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

3

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 and

development 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 in CRO CTMS

Data Scrubbing by CRO

Export from CRO CTMS

Data Conversion

Data Import into Sponsor 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

Create Accounts

• Create accounts and assign roles to accounts

• For each contractor; at each CRO

Provide Credentials

• Provide usernames and passwords

• To each contractor; at each CRO

Direct Data Entry

• 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 sponsor’s 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 CTMS’s

• 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 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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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

“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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Analysis of Key Considerations

Consideration Superdrug’s 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 contract research organizations

Technology