more gain, less pain - is irt tech transfer right for your clinical trials

© 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


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


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)


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.


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




“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




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)


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


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

Want to see the full webinar?

CLICK HERE

Ready to take the next step?

CLICK HERE

http://www.bioclinica.com/news-events/webinars/irt-more-gain-less-pain-irt-technology-transfer-right-you

CLICK HERE

more gain, less pain - is irt tech transfer right for your clinical trials

Healthcare