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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
“”
BRACKET ECOA™ AND BRACKET RTSM™ .................................................................................................................................................................................................................................................................................................. 6
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
The Benefits of a Single Platform
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
BRACKET ECOA™ AND BRACKET RTSM™ .................................................................................................................................................................................................................................................................................................. 8
The Benefits of a Single Platform
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
BRACKET ECOA™ AND BRACKET RTSM™ .................................................................................................................................................................................................................................................................................................. 9
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
“”
For more information on Bracket eCOA™ and Bracket RTSM™ integration services, contact us today.
(610) 225.5900 | Bracketglobal.com
AMERICAS | ASIA PACIFIC | EUROPE | MIDDLE EAST | AFRICA
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