bracket ecoa and bracket rtsm€¦ · bracket ecoa ™ and bracket rtsm ... support scale design,...

An eBook on the Unique Platform Integration Capabilities of Bracket’s eCOA and RTSM

BRACKETGLOBAL.COM

andBracket eCOA™

Bracket RTSM™

Introduction ................................................................................................................................................................. 3

About Bracket eCOA™ and Bracket RTSM™ ....................................................................................................... 4

The Benefits of a Single Platform .................................................................................................................. 5

Patient Activity ..................................................................................................................................................... 6

Technical Benefits ................................................................................................................................................7

Support Benefits .................................................................................................................................................. 8

Integration Features .............................................................................................................................................. 9

Conclusion ................................................................................................................................................................. 10

Addendum: References .......................................................................................................................................... 12

CONTENTS

BRACKET ECOA™ AND BRACKET RTSM™ ................................................................................................................................................................................................................................................................................................... 3

IntroductionBracket is the first clinical trial specialty services provider to offer

the unique integration of electronic clinical outcomes assessments,

Bracket eCOA™, and randomization and trial supply management,

Bracket RTSM™.

This combination provides users with a single platform to support the

logistics and supply chain management of clinical trials. The integration

also ensures tech-enabled clinical trials are interconnected and orderly,

not disruptive. The seamless integration is further supported by

Bracket’s development and launch of the first native RTSM mobile

application for Android and iOS devices.

The more recent advances

and popularity of cellular

and Wi-Fi technologies have

enabled the introduction

of mobile devices to capture

data for PROs, ClinROs,

and Observer-Reported

Outcomes … that introduce

new considerations for

management of these data.

David Rucker, Director eCOA Clinical Data Management Bracket

“

”

BRACKET ECOA™ AND BRACKET RTSM™ .................................................................................................................................................................................................................................................................................................. 4

About Bracket eCOA™ and Bracket RTSM™

Bracket offers a unique suite of solutions, with a unique perspective on clinical research development.

We focus on bringing together best-in-class science, technology and service to drive superior clinical outcome

results for our clients and their patients.

Bracket eCOA™ is a flexible platform for electronic

Clinical Outcomes Assessments that collects

information from patients (ePRO), clinicians (eClinRO)

and other observers (eObsRO). Bracket eCOA™ has

been an integral research tool across a vast number

of clinical trials, medication and disease management

programs, and comparative effectiveness studies.

Bracket eCOA™

Bracket’s Randomization and Trial Supply Management

(RTSM) platform provides quality optimization, consistency

within clinical programs and sponsor-specific needs and

timeline acceleration. Through Bracket’s deep expertise

in RTSM consultancy, coupled with our industry-leading

Study Configuration Wizard™, we offer clients rapid and

high quality results.

Bracket RTSM™

The Benefits of a Single Platform eCOA and RTSM integration enables subject questionnaires that trigger enrollment eligibility

and randomization to kickoff schedule of reported outcomes entries. Its advisory services

support scale design, development, licensing and validation, rater training and certification,

clinical review and quality assurance, data analytics and compliance tracking.

Bracket eCOA combines science and

technology to collect patient information

through smartphones or tablets, and

ultimately achieve higher quality outcomes

and efficiency in clinical trials.

Jeff Kinell Chief Executive Officer Bracket

“”


The Benefits of a Single Platform

Patient ActivityORGANIZED AND ACCURATE

» Better compliance from patients submitting data via ePRO

» Synergies between ePro Diary and RTSM provide higher quality

data and efficiencies

» RTSM visit data combined with ePRO daily transactions

provide accurate insights into patient activity

BRACKET ECOA™ AND BRACKET RTSM™ ................................................................................................................................................................................................................................................................................................... 7


Technical BenefitsDIGITALLY OPTIMIZED

» A single URL and login for sites

» Reduced legal hassles via single contract terms

» Faster access to information via digital—not paper—records

» Reduced duplication of patient screening numbers and identifiers



Support BenefitsUNIFIED AND ENHANCED

» A common project team and vendor instead of multiple vendors

and project teams

» Common helpdesk and support functions for clinical trial sites

» Better reporting and tracking throughout projects


Integration FeaturesSynergies between RTSM and eCOA data provide quick and easy insight

into the engagement, well-being and whereabouts of a patient throughout

the duration of a clinical trial.

» Data from RTSM can be used to project visit dates in patient’s

ePRO profile

» Reports with RTSM and ePRO data can be generated for sites

and sponsors

» Compliance reports can be viewed to capture patient status

» Specific alerts and reminders can be sent to the sites and patient

through devices or by SMS

Integration in ActionThe integration of Bracket eCOA™ and Bracket RTSM™ has been utilized in multiple US-based clinical trials, including studies for gastroenterology, metabolic disorders, and pain.

BRACKET ECOA™ AND BRACKET RTSM™ ................................................................................................................................................................................................................................................................................................ 10

ConclusionThe seamless combination of Bracket’s eCOA and RTSM is

an integration equipped for the mobile revolution. With the

support and connection needed to successfully manage

clinical trials, this platform and its mobile capabilities uphold

Bracket’s paper-free commitment and help to drive superior

clinical outcome results.

Electronic captured data

have become the primary

method for capturing data

for clinical trials within

the past decade.

David Rucker, Director eCOA Clinical Data Management Bracket

“”

BRACKET ECOA™ AND BRACKET RTSM™ ................................................................................................................................................................................................................................................................................................ 12

Data Manager Considerations for Integrating Electronic Clinical Outcome Assessment (eCOA) Data

Rucker, David. “Data Manager Considerations for Integrating Electronic Clinical Outcome Assessment (eCOA) Data.” Data Basics 22.4 (2016): 6-8. Print.

Bracket to Introduce Next Generation eCOA Platform at 2016 DIA Annual Meeting

https://www.bracketglobal.com/bracket-to-introduce-next-generation-ecoa-platform-at-2016-dia-annual-meeting/

Addendum: References

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