www.oracle.com www.touchbriefings.com BRIEFINGS Remote Data Capture: Acquisition and Analysis eClinical Visions HEALTH SCIENCES Contents: Trends and Issues in an Electronic Clinical Data Management World Patti Devereux Gaves and Alastair Clewlow, Oracle Health Sciences State-of-the-Science—The New Remote Data Capture Paradigm Robert R Goodwin, Pfizer, Inc. Improving and Monitoring Clinical Data Management in the eClinical Age James Streeter, PPD, Inc. Optimizing and Supporting Remote Data Capture Dave Hanaman and Rob Vollkommer, C3i, Inc. Oracle_BCandFC.qxp 27/5/09 11:55 am Page FC1
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www.oracle.comwww.touchbriefings.com
B R I E F I N G S
Remote Data Capture:Acquisition and AnalysiseClinical Visions
HEALTH SCIENCES
Contents:
Trends and Issues in an Electronic Clinical Data Management WorldPatti Devereux Gaves and Alastair Clewlow, Oracle Health Sciences
State-of-the-Science—The New Remote Data Capture ParadigmRobert R Goodwin, Pfizer, Inc.
Improving and Monitoring Clinical DataManagement in the eClinical AgeJames Streeter, PPD, Inc.
Optimizing and Supporting Remote Data CaptureDave Hanaman and Rob Vollkommer, C3i, Inc.
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Trends and Issues in an Electronic Clinical Data Management World
a report by
Patt i Devereux Gaves 1 and Alastair C lewlow 2
1. Senior Director, Life Sciences Product Strategy; 2. Director, Product Strategy for Clinical Data Management, Oracle Health Sciences
Over the last 15 years, Internet and eTechnologies have become an
integral part of everyday business in most sectors, but have taken time
to gain traction in the clinical trials arena. Now, as the industry faces
unprecedented challenges and further consolidation, companies are
increasingly embracing technology as a lever to differentiate themselves,
boost productivity, and succeed in the new environment.
The Internet, Pharma, and Electronic Data Capture
In the pharmaceutical industry, the emergence and acceptance of
Internet-enabled technologies such as electronic data capture (EDC)
have transformed clinical development practices, efficiently supporting
faster, larger, and more complex trials.
Current industry projections estimate that EDC is now used in
approximately 50% of all clinical trials (see Figure 1).1 Companies are
increasingly leveraging EDC and other tools to power global trials and
benefit from the ability to analyze incoming data and performance
metrics in real time. The availability of such data supports more rapid
decision-making and provides the agility to make necessary
adjustments during ongoing trials.
With increased adoption of EDC, market expectations for the
technology are high. A more technology-fluent user base is
demanding richer features, ease of use, and flexibility within trial
settings. Global usage also requires high availability and scalability.
Furthermore, there is a growing acknowledgement that EDC
represents only a subset of the critical aspects of the overall data value
chain, highlighting the need for a fully integrated eClinical ecosystem.
Such an integration of EDC and other eClinical systems will provide a
holistic view across trials and data sources and minimize process and
infrastructure redundancies.
In this dynamic environment, EDC and other clinical trial technologies
can deliver real fundamental benefits but also continue to introduce
new challenges as the eClinical evolution continues. Some of these
issues are discussed below.
Changing Roles for Data Management
Data management organizations in particular are front and center in
this bold new world. Due to the increasingly prevalent use of EDC
coupled with industry outsourcing trends, the role of an ‘in-house’
data manager has changed considerably. Further removed from the
daily discrepancy resolution routine, these individuals are now charged
with program-level oversight responsibilities, including tracking
progress of work being conducted by third-party contract research
organizations (CROs), and sometimes across multiple organizations on
several studies. While skills in the core data management systems are
still vital, better tools are necessary to provide oversight-level data in
real time, and productivity and performance metrics are paramount to
understanding and measuring this new environment.
Globalization and New Challenges
While ongoing global expansion of trials presents new opportunities,
it additionally increases the pressure and demands placed on EDC and
IT infrastructure and support resources. The growing prevalence of
global site users and outsourcing practices have transformed clinical
trials into an around-the-clock operation. This ‘always on’ business
model creates a technical support dilemma. Given the 24/7 availability
requirements to support the global trial environment, there is no
opportune time to schedule maintenance and perform repairs.
Trends and Issues in an Electronic Clinical Data Management World
Alastair Clewlow is Director of Product Strategy forClinical Data Management in the Oracle Health SciencesGlobal Business Unit. He has 12 years of experience in thepharmaceutical industry, beginning as a Data Manager at LEO Pharma before becoming a Clinical ResearchAssociate. Mr Clewlow relocated to Denmark in 2000 toimplement a clinical trial management system, beforebecoming Head of the Clinical Data and DocumentManagement Department, with responsibility for clinical
data management, clinical and safety systems support, and management of clinical trialdocumentation. He graduated from the University of Portsmouth with a BSc (Hons) inmolecular biology.
Patti Devereux Gaves is Senior Director of Life SciencesProduct Strategy for Oracle’s Health Sciences GlobalBusiness Unit. She returned to Oracle in June 2008 fromPfizer, where she held the positions of Senior Director,Technical Operations in Global Clinical Data Services, andDirector of Patient Data Systems in DevelopmentInformatics. She has more than 15 years of clinical datamanagement and related technology experience, andspent five years in Oracle’s clinical consulting group
leading customer implementations and delivery teams, as well as several years in datamanagement at Parke-Davis. Ms Gaves holds a BSc from Eastern Michigan University andan MA from the University of Michigan.
Robert R Goodwin is Vice President of Global Clinical DataServices at Pfizer. In this role, he is responsible for thedelivery of cost-effective and efficient centralized datamanagement activities for Pfizer and for the strategy andexecution of near-shore and off-shoring opportunities. Hehas introduced concepts of lean and six sigma to create amanufacturing mindset for data management, with a focuson cycle times, removing handoffs, and creating repeatabletasks for improved productivity. Mr Goodwin has 20 years of
industry experience in statistics, SAS programming, data management, electronic datacapture, and strategic project management. His previous positions include roles in theacquisition teams concerning the Warner Lambert and Pharmacia acquisitions, withresponsibility for data and processes. Mr Goodwin holds a BSc in psychology from EasternConnecticut State University, an MSc in research, measurement, and evaluation fromSouthern Connecticut State University, and an MBA in pharmaceutical and chemical studies.
James Streeter is Executive Director of Electronic DataCapture (EDC) at PPD, Inc, a position he has held since2006. He applies his extensive experience in EDC, dataacquisition, data management, and analysis, workingdirectly with clients to incorporate EDC into theirdevelopment programs. As the leader of PPD’s globalEDC core team, he provides project teams with thetechnical process and training support services necessaryto ensure proper deployment and execution during the
critical start-up, monitoring, and close-out phases of clinical studies employing EDC. MrStreeter gained much of his EDC experience at Pfizer as Senior Director of Global ClinicalData Services, heading the Global Data Acquisition Department for the company’s globalresearch and development organization. Prior to joining Pfizer, he was a senior hardware,software, and systems engineer for the US Navy Underwater Sound Laboratory, with afocus on data acquisition and analysis.
At the start of 2009, PPD is seeing
50% of its trials undertaken in an
electronic format. Within the next few
years, we predict that electronic trials
will overtake paper-based trials.
PPD_Streeter_revised1.qxp 12/5/09 4:35 pm Page 9
With a totally web-based platform such as Oracle RDC 4.5.3, these
disparate locations can communicate effectively. Employees can log in
from various locations both on- and off-site to manage, monitor, and
analyze data. The platform has a footprint of zero—it needs no
installation at the actual trial site—thus avoiding many potential setup
issues. Full training for the system can be achieved in 45 minutes to an
hour, and if a site already has experience using another EDC program,
the process is even easier.
New Research Areas
As companies push further into these new regions, it is important to
remember that many sites will be new to clinical research. In such
cases, implementing eClinical technology can prove challenging.
Moreover, relationship building and proper training is needed to
promote investigator confidence in using these platforms. Getting
clinical sites up and running can be especially problematic in
developing countries that lack the standard IT infrastructure.
However, technology challenges in these areas are starting to improve.
Technology is spreading rapidly and many of these regions are gaining
high-speed Internet links and other forms of access. Countries are
generally willing to adapt to eClinical demands quickly, with
investigators keen on using new technology platforms that can boost
their clinical trial parameters. Particularly poor areas, such as some
regions in Africa, completely lack basic communications infrastructure
such as telephone lines, and are likely to do so for some time to come,
but they have already made the leap to using cellular phones based
on wireless networks. New eClinical technologies that can run using
wireless communication networks or satellite links are emerging,
effectively bypassing the need for a classic IT infrastructure.
Enhancing the Investigator Experience
The importance of the investigator in implementing eClinical trials has
long been overlooked, but now enhancing the investigator eClinical
experience is becoming a key part of leveraging such technologies.
EDC platforms need to be user-friendly to give an investigator
confidence in using the system and to increase the efficiency and trial
workflow rather than slow it down. Finding clinical investigators is very
competitive and CROs are having to work harder to retain them.
There is also demand for an eClinical tool that allows investigators to
handle larger volumes of complex data more easily. With Oracle RDC
4.5.3, case report forms (CRFs) are easy to navigate and provide search
and sort functions and a robust system of edit checks to ensure data
accuracy. There is a combined interface for discrepancy management
and the CRF itself on one screen, so that users can scroll through and
work on discrepancies without having to add pop-up windows or use
different tools. In addition, investigators can interact with monitors
and data management teams in a more real-time fashion, which
means that they are able to close queries within days—something that
could take one to two months with paper-based systems.
10 E C L I N I C A L V I S I O N S
Improving and Monitoring Clinical Data Management
PPD global offices
Number of clinical trials
Canada = 4,768US = 33,369Mexico = 774Carribean = 1,010South America = 1,576Europe = 13,080Africa = 1,362Middle East = 1,952Russia = 947East Asia = 838China = 3,249Australasia = 1,882Japan = 907South-East Asia = 901
0–1,000
1,000–2,000
2,000–10,000
10,000–20,000
20,000–40,000
US (26)
Canada
Mexico
Peru
Chile
BrazilSouthAfrica
Belgium (2)UK (4)France
GermanyItaly
The NetherlandsSpainPortugal
SwedenDenmarkPolandCzech RepublicHungary
TurkeyGreece
Australia
Taiwan
Thailand
Singapore
India (2)
China (2)
Korea
Israel
Figure 1: Globalization of Clinical Trials and of PPD
Source: www.clinicaltrials.gov, July 2008.
Electronic data capture platforms
need to be user-friendly to give
an investigator confidence in using
the system and to increase the
efficiency and trial workflow rather
than slow it down.
PPD_Streeter_revised1.qxp 12/5/09 4:35 pm Page 10
Of course, the platform also literally reduces the volume of paper used,
so investigators no longer have to find storage for bulky casebooks. All
clinical data can be stored on a CD.
An Agent of Change
PPD has worked closely with eClinical providers such as Oracle
specifically on Oracle RDC, as well as its business intelligence, safety
packages, and clinical trial management system (CTMS). As part of its
strategic development partner (SDP) program, PPD has acted as a
customer advisor and worked as a beta tester on a pre-release version
of RDC 4.5.3. PPD’s investigator focus made it able to provide feedback
to Oracle on various issues and act as a voice for its various investigator
sites. PPD’s participation has helped increase investigator site
performance, simplify the user interface, eliminate software installation
issues, and realize a fully web-based system.
PPD particularly focused on how various eTechnologies would be used in
practice by investigators and assessed how the various tools could make
the job of the investigator easier. In the first instance, the firm directly
questioned investigators, asking what eClinical abilities they would need
to optimize their resources. The company also visited various investigator
sites as part of its research, getting feedback from investigators and
testing the systems first-hand to establish which add-on elements would
improve the platform and help trial management run more smoothly.
By focusing attention on investigator usage, PPD has become a
technology leader in the eClinical field. Understanding the
investigator’s technology needs improves the investigator’s relationship
with eClinical systems and its relationship with the CRO. As a result,
PPD is better able to retain investigators in wide-ranging global
locations, making it a more attractive proposition for potential clients.
It is not just investigators that have to cope with the switch to
eTechnologies; CROs must adapt too. Employing eClinical platforms
means huge changes for the day-to-day workflow of monitors and
project management staff. PPD has implemented comprehensive
training programs and hired employees experienced in using such
platforms. Once employees have sufficient training and are exposed to
eClinical studies, they start to feel the benefits to their workflow,
finding they can work faster and more efficiently, managing data and
responding to queries in real time.
Technology Integration
Unusually for a CRO, PPD also has its own informatics division—
CSS Informatics—which provides software for pharmaceutical,
biotechnology, medical device, and other CRO companies and offers
consulting services for clinical trial and drug safety applications.
CSS Informatics can host all types of eClinical EDC system for
clients and provide training on their use. As a result, PPD has
experience using a variety of eClinical systems on the market,
performing approximately 125 studies using Oracle Clinical RDC and
80 studies using third-party EDC platforms. The combination of PPD
and CSS Informatics’ service offerings creates a broad, integrated
service for clients.
Along with Oracle’s RDC platforms, PPD also has an in-house EDC
system. While Oracle’s RDC is more geared toward phase I–III trials,
which are more standardized in their trial management processes,
PPD’s proprietary EDC platform—GlobalView—is used for post-
marketing and medical device trials, as it allows for more dynamic
control of these extended and highly variable studies. As GlobalView
has a programming ability, PPD can integrate its system with Oracle
RDC to share data across both systems.
Future Perspectives
With each phase of eClinical development, technologies are
increasingly able to cope with larger, more complex trials, a trend
that is likely to continue into the future. For CROs, one of the biggest
issues will be ensuring adequate training for employees and
investigators using these systems. The future direction of all of these
systems will be determined by how well we can consolidate them and
integrate data.
Currently, there are a variety of eClinical systems, including CTMS and
safety and database management systems, that tend to work
separately. In the future, companies are looking to combine and
integrate these systems using data warehouses and business
intelligence, ending the need to sort data manually. In addition, web-
based platforms will make it far simpler for systems to communicate
with each other.
Eventually, technology will progress to where firms only need to set up
one central system to control all variables within the eClinical
paradigm. A single massive coordinated system would have a single
login for users to view all aspects of the trial in real time at any time.
Clinical trials using such a system would create cost and time savings,
allowing CROs to run their studies more efficiently and to collect
higher-quality data. The end result would be a more integrated
approach to eClinical technologies and faster, larger, and less costly
clinical trials. ■
11E C L I N I C A L V I S I O N S
Improving and Monitoring Clinical Data Management in the eClinical Age
Understanding the investigator’s
technology needs improves
the investigator’s relationship
with eClinical systems and its
relationship with the contract
research organization.
With each phase of eClinical
development, technologies are
increasingly able to cope with
larger, more complex trials.
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C3i_ad.qxp 8/4/09 4:50 pm Page 12
The use of electronic data capture (EDC) technology is becoming more
widespread: estimates are that approximately half of all trials now
employ EDC, and 32% of sites use Internet-based EDC,1 with spending
on EDC solutions set to exceed $3 billion by 2011—a 15% growth rate
from 2007.2 This means that sponsor companies have the capability to
run more complex and cost-effective clinical trials across the world.
Systems such as Oracle’s Remote Data Capture (RDC) platform are
designed to help sponsors and contract research organizations (CROs)
retain efficient and effective control over clinical trials in an
increasingly regulated industry. While new technology can be a great
enabling tool, it must be simple and useable for those at the heart of
the trial—the investigators. Burdening investigators with unwieldy,
intractable new technologies will not improve efficiency and can even
be detrimental to the progress of the trial.
In order to optimize the use of this innovative and promising
technology, investigators need access to training and specialized
technical support. Consequently, as the use of EDC platforms has
grown, so too have expert technology service companies such as C3i,
which act as a bridge between the investigator and the sponsor
company to provide that support network. C3i aims to maximize the
benefits derived from these enabling technologies and smooth the
transition from old to new technologies for investigators, whose main
focus needs to be on conducting the trial as efficiently as possible.
Clinical Trials and Tribulations
In an industry where new technology is constantly replacing old and
new challenges are being met, clinical trial design and management is
also progressing. EDC methods represent an important leap forward in
clinical trial technology, allowing for more reliable record keeping,
easier access to data from multiple sites across the globe, and larger
trials that can be completed more quickly and efficiently than ever
before. However, the transition period while implementing any new
technology is unlikely to be entirely smooth. Programs such as Oracle
RDC will undoubtedly improve and modernize clinical trial operations
in the pharmaceutical industry in the long term, but setting
up the new platform or upgrading the old one can present many
challenges in the short term, one of the biggest of which is to make
the entire environment user-friendly for investigators and investigator
site staff.
The Growing Demand On and For Investigators
While pharmaceutical companies and CROs will be highly familiar with
the technology they are working with, the same is not true of
investigators. It is important to remember that investigators will have
other daily duties alongside running trials, many of which will require
their own tools. Any time spent struggling with a program or
technology for a specific trial will be a substantial burden on their
resources, and is unlikely to give them a positive view of the trial
sponsor. For them, EDC should be an enabling tool that helps
streamline workflow. However, this has not always been the case; in
the past, such programs have rarely been designed with investigators
in mind.
In addition, recruiting investigators for a study is a critical process, and
one that is getting harder as the number of trials rises (see Figure 1).
Sponsors and CROs effectively have to compete for the best
investigators, who should therefore be treated as customers rather
than employees or associates. Thus, the sponsors and CROs must be
easy to work with, and that is reflected in the technology they use. It
Optimizing and Supporting Remote Data Capture
a report by
Dave Hanaman 1 and Rob Vol lkommer 2
1. Executive Vice President and Co-Founder; 2. Vice President, Clinical Services, C3i, Inc.
Dave Hanaman is Co-Founder and Chief Sales andMarketing Officer for C3i. He is responsible for sales,marketing, product development, and alliances.Additionally, he consults directly with many of C3i’s blue-chip clients. He is experienced in a wide variety ofsubjects related to clinical support operations andcustomer relationship management, focusing on thetechnology environment, performance improvement, andreturn on investment. A frequent lecturer and prolific
writer, Mr Hanaman has developed and taught courses for universities, spoken at industryconferences, and written numerous articles, and is frequently quoted in the industry press.A graduate of the University of California at Berkeley, he also served as an IntelligenceOfficer in the US Navy.
Rob Vollkommer joined C3i in November 2002, and iscurrently Vice President of Clinical Support Services.He is responsible for the development and delivery ofsupport services to meet the specific requirements of thecompanies conducting clinical trials (e.g. multilingual helpdesk, user accounts creation/administration, technical siteassessments, and Internet-based training). He holds a BScin electrical engineering from Columbia University and anMBA in management and operations management fromNYU Stern School of Business.