© 2013 BioClinica, Inc. – Proprietary and Confidential
Global clinical trial solutions. Real-world results.
© 2014 BioClinica, Inc. – Proprietary and Confidential
IRT: More Gain, Less Pain – Is IRT
Technology Transfer Right for You?
2© 2014 BioClinica, Inc. – Proprietary and Confidential
IRT Defined
• IRT = Interactive Response Technologies
› Typically a placeholder term for• IWR = interactive web response
• IVR = interactive voice response
• IRT systems are used to:
› Randomize subjects into treatment groups
› Dispense study drug to subjects
3© 2014 BioClinica, Inc. – Proprietary and Confidential
IRT Software as a Service (SaaS)
• For IRT SaaS BioClinica provides:› The IT infrastructure
› The configurable IRT application
› The resources needed to• Create the specification
• Build/configure the study
• QC the study configuration
• Support the study (data and configuration changes, supply management, site and user changes, etc.)
• Address issues with and manage enhancements to the core product
› Help Desk support
4© 2014 BioClinica, Inc. – Proprietary and Confidential
IRT Tech Transfer – Responsibilities
• Tech Transfer Ownership (most common in bold)
› The IT infrastructure (BioClinica or Client)
› The configurable IRT application (BioClinica)
› The resources needed to• Create the specification (BioClinica or Client)
• Build/configure the study (BioClinica or Client)
• QC the study configuration (BioClinica or Client)
• Support the study with data and configuration changes, supply management, site and user changes, etc. (BioClinica or Client)
• Address issues with and manage enhancements to the core product (BioClinica)
› Help Desk Support (BioClinica or Client)
5© 2014 BioClinica, Inc. – Proprietary and Confidential
Are you a good candidate for IRT Tech
Transfer?
You are a good candidate for “all in” if:
› You have project managers, technical resources, and QC resources with IRT experience – they know what to do and just have to learn how to work with Trident
You are a good candidate for a hybrid approach if:
› You have a subset of the resources needed for “all in” and they have regulated systems experience
› BioClinica will provide support as needed while training your resources to be self-sufficient
Hybrid
All In
Actually, everyone is a good candidate for IRT TT.
6© 2014 BioClinica, Inc. – Proprietary and Confidential
What do you need in order to be
successful with IRT Tech Transfer?
“All in” approach:› BioClinica resources ready to:
• Configure servers• Install the application and database• Install application updates
› Your Project Managers (Implementation/Design) ready to:• Manage timelines and deliverables• Create specifications (IRT and Integration
Spec)
› Your Study Builders ready to:• Configure studies and integrate with
upstream and downstream systems• Unit test
7© 2014 BioClinica, Inc. – Proprietary and Confidential
What do you need in order to be
successful with IRT Tech Transfer?
“All in” approach (cont.):› Your QC resources ready to:
• Write QC and testing related documents• Verify study configuration/integration• Execute test scripts• QC study maintenance activities
› Your Project Managers (Maintenance) ready to:• Manage study changes• Manage study issues (supplies, etc.)• Ensure study is meeting design
requirements
› Help Desk
8© 2014 BioClinica, Inc. – Proprietary and Confidential
What do you need in order to be
successful with IRT Tech Transfer?
Hybrid approach:› Shared Operations
• Determine which resources (BIOC or Client) will do which operational tasks (e.g. spec writing, building, testing, etc) across all studies.
– Complex integrations, complex data changes and complex randomization/clinical supply
› Shared Resources• Determine which resource will be
responsible for which studies across the entire customer pipeline. (e.g. customer manages 15 studies, while BIOC manages (full service) 5 studies to help with customer resource constraints)
9© 2014 BioClinica, Inc. – Proprietary and Confidential
What makes Trident a good fit for
IRT Tech Transfer?
Powerful
› Complex visit schedules and
dosing factors are easy to set
up
› Unlimited strata and ranges may
set up and used for rand
blocking
› Branching logic
› Predictive resupply
› Drug pooling
Revolutionary
› No programming for most
studies
› Implicit built in parameter-
driven admin/build tool
Results in:
› Business users empowered
to set up, test and deploy
new protocols
› Easily monitor and maintain
studies without need for
programmers
10© 2014 BioClinica, Inc. – Proprietary and Confidential
What makes Trident a good fit for
IRT Tech Transfer?
Flexibility
› Allows for last minute
changes without affecting
FPI date
› Eliminates costly, slow
development/validation
processes
Results in:
› Accommodate
reconfigurations to system
in little time and minimal
cost
Elegance
› Dynamic context-aware
presentation
› Clean, modern design
Results in:
› Powerful yet simple User
Interface
› Intuitive and easy-to-use
Only tech transfer capable IRT system in the marketplace
© 2013 BioClinica, Inc. – Proprietary and Confidential© 2014 BioClinica, Inc. – Proprietary and Confidential 11
Trident IRTplus
Program Components
Give You Control Over All Activities Required to Build and Support IRT Studies
GOAL:
© 2013 BioClinica, Inc. – Proprietary and Confidential© 2014 BioClinica, Inc. – Proprietary and Confidential 12
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