PHT Medical Device Software

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

phtcorp.com