Make the Most of Every Patient Helping the clinical research industry develop new therapies, treat diseases and improve quality of life.
LogPad® System SitePad™ Tablet eSense™ StudyWorks™ SimpleSend™ Transmissions Study Archive ePRO Designer™ Trial Success Program™ ISO Certification Study Support Center
phtcorp.com
Technology for Science PHT Corporation was founded in 1994 out of a desire to enable better science. At the time, scientific researchers relying on paper diaries needed a way to capture reliable data from patients between clinic visits. PHT patented the model of using handheld devices in conjunction with online technologies in order to send subject self-assessments directly to a central server. These data could then be reviewed in real time for improved subject symptom, compliance, enrollment and safety monitoring. This model, invented by PHT, is now known as the modern electronic patient reported outcome (ePRO) industry. Today, ePRO solutions have become the gold standard in clinical research worldwide where self-reported and health-related quality of life data are used as primary and secondary endpoints. PHT continues to lead the industry in both experience and innovation with the LogPad® System, SitePad™ Tablet and eSense™ measurement devices — all designed to improve data quality, enhance subject safety and streamline study management. By providing firsthand knowledge, PHT helps sponsors make the most of every patient.
"With the (LogPad) you have a daily routine, seven days a week. You don’t miss it, so you can’t go wrong.” — Edward Goldwire, patient in a Temple University COPD disease management study
“ We evaluated several providers but selected PHT because of their expert scientific team and in-depth industry experience.” — Brad Whitlow, Clinical Project Manager, Greer Laboratories
The Voice of the Patient - Delivered PHT’s integrated ePRO Product Suite offers sponsors a complete and reliable technology solution comprised of the most-used ePRO products in the world.
LogPad System
eSense
The LogPad increases diary compliance
eSense allows scientific researchers to
and improves data quality by making it
move beyond the limits of paper diaries
easy for subjects to respond. Branch-
by capturing objective physiological data
ing logic, reminder alarms, formatted
in conjunction with subjective eDiaries.
response options and a myriad of other
PHT supports wireless integration with
features guarantee that all reports are
measurement devices such as PEF
timely, complete, logical and legible.
meters and glucometers in order to
Because diaries are only available during
capture a complete picture of the patient
“In the past, I have been involved with numerous pain research trials using paper diaries… The LogPad’s timestamped data alone gives our trial a
the times specified by the protocol,
experience. With eSense, subjects are
the LogPad eliminates recall bias and
unable to invent data or enter incorrect
much higher scientific validity
forward-filling. This minimizes noise in
values, thereby ensuring sponsors that
from a regulatory standpoint.”
the data and allows sponsors to do more
devices are used appropriately and in a
with fewer subjects. The end result is
timely manner.
— Dr. Nacer Dean Abrouk Vice President of Biostatistics
trustworthy ePRO data to support safety
DURECT Corporation
and efficacy analyses, critical decisions, and regulatory submissions. SitePad Tablet With its large screen and intuitive fingertip data entry, the SitePad Tablet has revolutionized site-based eSource data capture. It ensures all questionnaire data
LogPad eDiary
are captured appropriately, completely and on time, while also benefitting sites with automatic scoring and efficient tools for subject and visit management.
SitePad Tablet
StudyWorks™
SimpleSend™ Transmissions
Permanent Study Archive
PHT’s online portal provides standard
Subjects and sites must be able to transmit
The Study Archive is the only lasting
and custom data summaries which
data reliably to activate real-time benefits.
evidence that a clinical trial ever occurred.
allow sites and sponsors to manage
PHT’s robust SimpleSend family of tele-
Therefore, it needs to be permanent, easy
global clinical trials in real time. Study
communications options enable analog
to navigate and comprehensive. Only
coordinators review subject symptoms
and wireless data transmissions from any
PHT, however, offers such a best-of-breed
and compliance on a daily basis, while
device. SimpleSend ensures user-friendly
eSource archive. By utilizing searchable
SafetyPRO™ email alerts enable unprec-
and consistent transmissions from
XML format data in addition to standard
edented levels of proactive monitoring.
anywhere in the world, regardless of the
PDFs, PHT’s archive (which includes audit
Sponsors benefit from tracking the
underlying geographical infrastructure
trails and signatures) enables full trial
study’s enrollment and progress across
(or lack thereof).
reconstruction and data mining years
sites and countries to ensure timelines
after close-out in order to fulfill regulatory
remain on track. Further, eSource data
requirements.
transfers are available in a number of formats (SAS, ASCII, Excel, CDISC ODM)
ePRO Designer™
and are easily integrated with EDC,
This rapid design application facilitates
CDMS, IVRS and other eClinical systems.
the development of validated eDiaries and prototypes. To supplement this tool, PHT performs a full system validation of every individual trial design as part of ISO certified quality best practices.
Success through Service PHT invented the modern ePRO industry with eDiary product innovations, but became the market leader thanks to proven Client Service and Project Management.
ePRO Experience
Trial Success Program™
PHT is trusted by biopharmaceutical
PHT’s Trial Success Program (TSP) is a
and medical device companies of all
set of institutionalized processes for
sizes (including nearly all of the Top 20)
trial deployment and management. TSP
in clinical research programs spanning
is comprised of four functional phases:
numerous indications in every major
Study Setup, Deployment, Tracking and
therapeutic area. This unrivaled eDiary
Closeout. Each phase consists of specific
experience enables PHT’s design and
responsibilities and deliverables carried
delivery teams to make best practice
out by consistent Project Management
recommendations based on key learnings
teams following the recognized Project
from each study deployed. Whether
Management Institute (PMI) Body of
implementing a small research study or
Knowledge Guide.
“ Sponsors need to know that issues may arise using ePRO technology no matter what vendor they choose, but PHT is the vendor you want solving these issues. PHT’s service is one of the best in the industry. This is why
a complex global program, PHT works closely with sponsors to deliver success.
I will choose PHT for my next trial!”
ISO 9001:2000 Certification Across industries, independent ISO cer-
— David Burnham,
tification means well documented SOPs
Director, Clinical Research,
are followed and continually improved.
PediaMed Pharmaceuticals, Inc.
PHT is the only handheld ePRO provider to achieve and maintain ISO certification. To clients, ISO stands for peace of mind — resulting in effective designs, consistent service, reliable technology and repeatable quality standards.
“ PHT’s quality management system is without question the best I have ever seen in over 20 years of development and auditing experience.” — Joe Buonomo, Director of Clinical Programming Systems Evaluation and Management, at a major pharmaceutical company
StudyWorks™ Compliance Report
Study Support Center
Trusted Global Deployments
When issues occur, sponsors want an
A well-designed ePRO solution doesn’t
ePRO provider that responds quickly.
meet any scientific requirements if the
Perhaps no service is more valued by
eDiaries are stuck in Customs. Shipping
clients than PHT’s internal Study Support
technology products to sites around the
Center (SSC). Staffed exclusively by
world requires sole accountability and
full-time, dedicated PHT experts trained
clear understanding of timelines, and
in the details of every active study, the
experience. PHT’s internal Production
SSC provides immediate answers,
department and Exports Management
multi-language support and rapid
team leverage a customized Oracle EBS
escalation, 24x7, to resolve over 95%
enterprise system to deliver superior
of all issues during the first call.
service with reliable logistics to clients worldwide.
Going PRO Whether new to ePRO or experienced with dozens of eClinical trials, sponsors working with PHT benefit from unique scientific expertise and exclusive technological features which ensure a successful trial.
PROVision™ PHT’s desire to enable better science is permeated throughout the entire organization. The PROVision science team consists of thought leaders experienced in both clinical research and technology. They are actively involved to help sponsors meet their scientific objectives with many standard services: • Protocol review and customized demonstrations • Diary design recommendations (technical and clinical) • Consulting on meeting FDA expectations for PRO instrument validation • Collaboration with sponsors and questionnaire developers
PROTect™ Assurances Technological innovations enable sponsors to achieve new heights in scientific research possibilities and data security. Advanced features available only to PHT clients: SafetyPRO™ Alerts
Real-time email and phone alerts are triggered immediately as a troublesome value (e.g., a suicidal ideation) is reported
Missed Diary Minder
Configurable notifications are based on custom thresholds for subject diary compliance
TrueCompute™ Calculations
Dynamic symptom scores, eligibility evaluations and baseline comparisons are derived from real-time and prior subject responses
Three-Phase Commit™
Standard security best practices ensure transmitted data are tamper-proof and stored in at least three places at all times
Total Server Redundancy
Two remote data centers provide above-and-beyond data security and backup for every trial
100% Application Integrity
Advanced application features offer real protection against eDiaries reverting to standard devices even after a hard reset, soft reset or battery loss
“ The best thing for me is I can check real-time StudyWorks reports every day. Every day I know how patients are feeling. And I see what monitors have to do with paper diaries… it’s a lot of work. I see them doing it and I think, ‘I’m glad I don’t have to do that!’” — Anne Jansen, Study coordinator in an Amsterdam, the Netherlands, allergy trial
ePRO Advantages Sponsors, sites and subjects all benefit from eClinical solutions, as evidenced by the continued growth of the use of ePRO in Phase I-IV studies worldwide.
Subject Experience
Sponsor ROI
Subjects enjoy using ePRO because it
Reliable ePRO systems offer sponsors a
helps them easily provide good data
true return on investment in addition to
due to reduced respondent burden
trustworthy data for regulatory submis-
and convenient mobile devices. Bright
sions and approvals. Leading pharmaceu-
screens with large fonts aid the elderly,
tical companies such as Merck Research
kid-friendly graphics and a Caregiver
Laboratories and Novartis have demon-
Module simplify responses in pediatric
strated that the LogPad System reduces
trials, and private access codes elicit
data variance as compared to antiquated
honest responses. Perhaps most impor-
paper methods — on the order of 35%
tantly, patients report that the regular
or more. Such a proven increase in data
data transmission fosters a stronger con-
quality enables sponsors to run smaller
nection with their site. This encourages
and faster Phase II studies (saving cost
subjects to stay active and vested in the
and exposing fewer subjects to investi-
study, thereby increasing compliance,
gational therapies) and more scientifi-
reducing drop-outs, and promoting
cally conclusive Phase III trials. ePRO
accurate reports.
eliminates overlooked paper processes such as double data entry, voluminous
Site Perspective
paper record management, manual cal-
Interviews with sites around the world
culations, delayed diary database lock,
help PHT develop tools and refine
and larger-than-needed sample sizes to
processes to improve efficiency. Study
account for excess noise in the data.
coordinators using ePRO benefit from the confidence that all eDiary reports are completed appropriately, thus freeing them to focus their time on caring for patients. PHT supports sites with standardized questionnaire administration, on-screen eligibility calculations, real-time compliance and enrollment, site-to-subject messaging, SafetyPRO alerts, and a 24x7 help desk. Employing staff trained in modern eClinical technologies also enhances site efforts to attract more cutting-edge clinical studies.
“Overall, I was always comfortable using (the LogPad). And I think it’s good to know the data couldn’t possibly get lost. That, in particular, is about 100% better than paper.” — Elderly female subject in a rheumatoid arthritis trial in Cambridge, UK
Don’t take our word for it… Build and your own LogPad eDiary online at phtcorp.com
Make the Most of Every Patient
PHT Corporation 500 Rutherford Avenue
2, chemin Louis-Hubert
Charlestown, MA 02129, USA
1213 Petit-Lancy, Geneva, Switzerland
Toll-Free: 877-360-2901
41.22.879.91.00
Copyright Š 2008 PHT Corporation
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