CRF Health partnered with a top pharmaceutical manufacturer to support a large Phase III COPD trial involving over 19,000 patients across 35 countries, utilizing their trialmax® eCOA platform for efficient data collection and management. The study emphasized global logistics expertise, with the timely distribution of over 15,000 handheld and 1,000 tablet devices, enabling real-time monitoring and compliance. With robust support services and multilingual helpdesk operations, CRF Health established a successful collaboration that has led to the collection of over 23 million data points and additional awarded studies.

1. World's Largest
COPD Trial
Requires Reliability
and Global Scale
Case Study

2. Case Study
© CRF Health. All rights reserved.
CRF Health and its TrialMax® eCOA platform were adopted by a top 50 global
pharmaceutical manufacturer to support one of the largest recorded phase III
studies in chronic obstructive pulmonary disease (COPD). The trial, involving
more than 19,000 patients in 35 countries, leveraged TrialMax® to deliver
electronic versions of key COPD instruments, enabling investigators to monitor
exacerbations while making compliance as easy as possible for patients.
A complete eCOA platform should offer features that streamline and
simplify the process for collection and management of patient data in
real-time. A reporting portal should offer easy-to-use visual dashboards to
help investigators identify noncompliant sites and patients, along with the
ability to deploy alerts and reminders instantly. With nearly 20,000 subjects,
the technology should also be able to seamlessly and reliably collect large
amounts of data while following the proper workflow.
The study team chose CRF Health as its eCOA partner for
its expertise, industry reputation, and because it
demonstrated it could meet the extenuating needs of
one of the largest clinical trials to date.
Complete Data Collection,
Management & Reporting
With any technological implementation, it's important to have
access to a support team that can answer questions or triage
escalations when they happen. If a patient is reporting an
issue, study teams need access to that data immediately to
address the patient's concerns. Similarly, if end users have
questions about properly using the eCOA technology, they
require instant support. The global scale of this study required
helpdesk services to be available in over 70 languages, 24/7.
Essential were the ability to manage a large scale inventory of over 16,000
devices across 900 sites, capacity for global, multi-device shipments within
the sponsor-established timelines, and availability of around-the-clock
logistics support.
Global Scale Logistics
& Device Management
Multi-Lingual Helpdesk
to Support Site and Patient Inquiries
This landmark COPD study
contained an outstanding
number of subjects,
countries, sites, investigator
meetings and devices.
Study
Design
900
sites
19,000screened subjects
18,000randomized subjects
70languages
15,000
TrialMax Touch® home-based handheld devices
35countries
1,000
TrialMax Slate® site-based tablet devices
25investigator meetings
As they prepared to launch their groundbreaking phase III study, the sponsor
sought out an eCOA partner that could deliver both dependable technology
and expertise in global logistics management. The sponsor focused on
selecting an eCOA partner with expertise in three main challenge areas:
The Challenge
Study Overview

3. Case Study
The client requested that CRF Health ship over 800 devices in
the first 10 days alone, and over 8,500 devices in the first seven
months, comparable to the annual volume of five mid-sized
eCOA studies! Logistics expertise was the number one
customer concern for the study, and on-time device shipments
were essential to meeting the overall study deadlines.
CRF Health, the CRO, and Sponsor needed to communicate to effectively and
clearly define and understand First Patient First Visit (FPFV) dates for the
hundreds of international sites participating in the trial. This ensured that CRF
Health could accommodate the thousands of shipments as scheduled and on
time. Other ongoing support included the CRF Health Helpdesk, which
supported the influx of an additional >200 weekly support calls.
Study Collaboration
& 24/7 Support
Global logistics knowledge, planning, and execution have played a key role in
the success of this ongoing trial, now in its second year. To date, CRF Health has
collected over 23 million data points in this trial and has been awarded two
additional studies as a result of the success and client relationship developed.
CRF Health deployed 15,000 TrialMax Touch® handheld devices and 1,000 TrialMax Slate® tablet devices during this study. In addition to completing
a questionnaire on the TrialMax Slate® at every site visit, patients were also required to complete a daily morning and evening diary on their
provided TrialMax Touch® handheld device. CRF Health's eCOA solution supported greater efficiency, accuracy, and privacy compared to the time
and effort that paper would have required from both patients and sites.
With two daily entries required from patients and consistent data management required from sites, CRF Health focused their expertise on the
following areas to ensure successful eCOA implementation:
The at-home morning and evening diaries were custom designed with built-in logic that
alerted study teams when subjects displayed worsening COPD symptoms, allowing proper
action plans to deploy to protect participants.
Planning and Preparation
for Global Logistical Support
Efficiencies for a Successful
& Sustainable Study
800
2,800
5,700
8,500
10 days 2 months 5 months 7 months
Total quantity
of devices shipped
over time
1,550 total shipments
in first 10 months
3,200 helpdesk calls
in first 10 months
Developing High Performing
Sites and Patients
CRF Health implemented several eCOA features to help the client improve
efficiency. Configuring users on TrialManager®, CRF Health's online portal for
real-time data review, simplified visit activation to expedite the time to get to
the assessment. TrialManager® also enabled site access to customized reports
that measured subject compliance for study sustainability. Additionally, with
over 70 different languages represented, CRF Health managed the
localization, including the translation and transcription of the questionnaire,
to ensure patient comprehension and compliance.
Both the sponsor and CRF Health believed in designing with the
end-user in mind so that the eDiaries provided to patients
would be intuitive and easy to use. To assist with this and
reduce burden, CRF Health provided training during the initial
25 Investigator Meetings held for study teams. As the study has
progressed, the number of Investigator Meetings continues to
rise to maintain knowledgeable personnel that can assist
subjects with the use of the devices and questionnaires.
23,000,000 data
points
Study Results
Study Solution

4. About CRF Health
For more information, please visit www.crfhealth.com
or email info@crfhealth.com
CRF Health is the leading provider of electronic Clinical Outcome Assessment
(eCOA) solutions for global clinical trials. With experience in more than 800 trials,
over 100 languages and across 74 countries, CRF Health's TrialMax® eCOA solutions
consistently demonstrate the industry's highest data accuracy, patient and site
compliance, and patient retention.
CRF Health's TrialMax eCOA solutions improve trial engagement by fitting into the
lives of patients and seamlessly integrating into sites to maximize protocol
compliance.
CRF Health®, TrialMax®, TrialMax Touch®, TrialMax Slate® are registered trademarks of CRF Inc. C-R-F Health Simply Reliable Design, Simply
Reliable™, and TrialManager™, are trademarks and/or service marks of CRF Inc. REV12062016