This document discusses different methods for sharing clinical trial management system (CTMS) data between sponsors and contract research organizations (CROs). It begins with an overview of current industry trends driving increased outsourcing to CROs and the need for collaboration on data sharing. Three main methods are described: CRO export/sponsor import, CRO access to sponsor CTMS, and CRO-sponsor CTMS integration. For each, benefits and drawbacks are outlined. A scenario analysis examines applying the methods to a fictional sponsor's specific needs and resources. The analysis recommends CRO-sponsor integration as the best option to meet the sponsor's requirements for timely data, limited resources, and scalability to support growth.

1. 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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2. 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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3. 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
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4. 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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5. 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. Implement technology solutions
2. Outsource
• As of 2010, 50% of clinical trial activities are being
outsourced
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6. 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
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7. 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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8. 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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9. 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
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10. 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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11. 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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12. 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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13. 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 sponsor’s production CTMS
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14. 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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15. 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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16. 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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17. 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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18. Scenario-Based Analysis of Data Sharing Methods
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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19. 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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20. Q&A
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21. Closing
Thank you for attending!
www.biopharm.com
psingh@biopharm.com
+1 877-654-0033
+44 (0) 1865 910200
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