Brochure from CBI's 4th Annual Forum on Clinical Trial Management Systems (CTMS). BioPharm Systems held a workshop on how to build an effective CTMS training program at the event.

1. R e g i s t e r b y J a n u a r y 2 1 , 2 0 1 1 a n d R e c e i v e $ 3 0 0 O f f o f Yo u r R e g i s t r a t i o n F e e !
CBi’s 4th annual forum on
Clinical Trial Management
Systems (CTMS)
Adoption, Integration and Management Solutions
to Maximize the Value of Investments
March 24-25, 2011 • crowne Plaza • PhiladelPhia, Pa
Balanced
perspectives
ConferenCe Chairperson: Leverage CTMS to enable strategic regarding various
types of CTMS
Karen Travers, Director, Product Strategy, clinical operational efficiencies systems
Oracle Health Sciences
Analyze criteria used to make a CTMS selection
fDa aDDress:
“Understand Potential Regulatory Learn the benefits and challenges of co-developing a
Issues and Inspection Expectations”
Jonathan S. Helfgott, Consumer Safety Officer,
CTMS with a CRO versus purchasing an application
CDRH’s Division of Bioresearch Monitoring,
Food and Drug Administration Understand resource requirements for data migration
resulting from a merger of two separate systems
national CanCer
institute aDDress Manage shared CTMS data between sponsor and CRO
“NCI Update on the (caBIG ) Initiative” ®
David Loose, Contractor, NCI Center for Biomedical Adapt CTMS to incorporate payment structure shifts
Informatics and Information Technology (CBIIT)
Bill Dyer, Contractor, NCI Center for Biomedical Lower Total Cost of Ownership (TCO) through
Informatics and Information Technology (CBIIT)
CTMS simplification
aCaDemiC meDiCal Choose Between Two Pre-Conference Workshops — Thursday, March 24, 2011
Center aDDress:
“A Site-Based Approach to CTMS”
A. Increase ROI B. Build Organizational
Anthony Leiro, Manager, Business Architecture, Information
Technology, Duke Clinical Research Institute (DCRI) through an Bridges for Cross-Functional
Effective CTMS Collaboration and
Case stuDies anD Training Program Decision-Making
perspeCtives from:
BioPharm Systems • DSP Clinical Research Presenting Lead Media Partner:
Sponsor:
Ferring International PharmaScience Centre
Genentech, A Member of the Roche Group
Artwork by: Getty Images
GlaxoSmithKline • Merck & Co., Inc.
Millennium: The Takeda Oncology Company Organized by: Lead Media Partner:
Perceptive Informatics • Quintiles
sanofi-aventis • Sanofi Pasteur • Target Health
A Subsidiary of For more information, please visit us
on the web at www.cbinet.com/ctms

2. Choose f rom Two Pre-Conference Work shops – Thursday, Ma rch 24, 2011
7:30 Workshop Registration and Continental Breakfast
8:30 • Workshop A 8:30 • Workshop B
Build Organizational Bridges
Increase ROI through an Effective
for Cross-Functional Collaboration and
CTMS Training Program
Decision-Making
Workshop Objective: Workshop Objective:
User adoption is the key to achieving a rapid ROI for CTMS systems are utilized by many key stakeholders, both internal
your CTMS and the key to user adoption is an effective and external to the organization. There are individuals that make
training program. Such training programs are based on decisions regarding the system; those that support the system; and
a careful analysis of an organization’s culture and the those that use the system. It is important to realize that decisions
characteristics of its end-users. All training programs regarding CTMS impact all key stakeholders and therefore
should be multi-faceted, comprehensive and long-term in processes for collaboration are critical. This workshop covers
scope. But, depending on the organization, the details of a cross-organization collaboration and decision-making while also
program can be tailored to meet the needs of the end-users focusing on the relationship with CROs, between the business and
and the organization as a whole. Effective CTMS training technical teams as well as key end-users.
programs leave users feeling well-equipped to begin using Key Questions to Be Addressed:
the system and fully supported as they master it. This
workshop presents a variety of methods for achieving these • Who should be involved in a cross-functional advisory committee?
goals and discusses how to choose from these methods to • What is the impact of CTMS changes on other clinical systems?
build a training program that is right for your organization. • How is a stronger relationship between business and technical
teams created?
Key Questions to Be Addressed: • How is feedback from end-users incorporated into the
decision-making process?
• How do adults learn?
Workshop Outline:
• What are the different approaches to software training?
• Which approaches make sense in different types I. Ensure Cross-Functional Decision-Making for
of organizations? CTMS Systems
• How can we best prepare users to start using the system? • Understand business priorities and current
• How can we continue to support users over time? decision-making structure
• Create a cross-functional key stakeholder advisory
Workshop Outline: committee to address questions
* level of access granted to CROs and other business
I. Understand How Adults Learn partners that comply with privacy regulations
• Motivating them to learn • Make key decisions for CTMS initiatives
• Helping them retain what they learn * business process changes impacting initiatives
timeline changes
• Helping them apply what they learn
• Implement a Change Control Board (CCB)
II. Analyze Your CTMS User Group * evaluate changes to system itself, both business and technical
• Organizational culture * determine impact of CTMS changes on other clinical systems
• Number and types of users II. Create Stronger Relationship between Technical
• Location of users Operations and Business
• Understand change requests from business
III. Develop Your Training Program/Strategy • Evaluate issues impacting systems
• Short-term — Initial rollout • Eliminate technical and business silos
• Medium-term —
Reference materials and refreshers III. End-User Forums to Provide Consistent Feedback
• Long-term — • Grass-roots forum where users can voice concerns, challenges
Clear and effective support structure • Discuss best practices
• Hear lessons learned to date
12:00 Close of Workshop A 12:00 Close of Workshop B
There will be a 30-minute networking and refreshment break at 10:00 a.m.
There will be a 30-minute networking and refreshment break at 10:00 a.m.
Workshop Leaders: Workshop Leader:
Parambir Singh, Vice President, BioPharm Systems, Inc
Amy Black, Global Business Program Manager,
Shannon L. Beebe, Siebel Coordinator, Covidien Genentech – A Member of the Roche Group

3. MAIN CONFERENCE National Cancer Institute Address
3:30 NCI Update on the (caBIG®) Initiative
Day One — Thursday, March 24, 2011 The cancer Biomedical Informatics Grid (caBIG®) initiative,
overseen by the National Institutes of Health’s (NIH), National
12:00 Main Conference Registration Cancer Institute (NCI) Center for Biomedical Informatics and
1:15 Chairperson’s Opening Remarks Information Technology (CBIIT), was conceived to connect the
Karen Travers, Director, Product Strategy, Oracle Health Sciences cancer research and clinical community through a semantically-
Ms. Travers has over twenty years experience in Clinical Research working aware service-based, open-source, interoperable technology
in both industry and CRO environments. Her experience includes Data that facilitates data sharing and collaboration to accelerate
management, Clinical Monitoring, EDC, IVRS and Medical Imaging. the translation of discoveries from research to clinical care.
Prior to joining Oracle, she was at Vertex Pharmaceuticals where she led The caBIG® Clinical Trials Management Systems Workspace
strategy and implementation of Clinical Development Systems. She was also provides modular caBIG® software tools designed to meet
at Perceptive Informatics (a Parexel International Company) where she led diverse clinical trials management needs. caBIG® tools are
efforts around IVRS, EDC and Medical Imaging. configurable to work with clinical sites with little or no clinical
data management systems in place, as well as those with robust
Keynote Address systems; and take into account the diversity of clinical research
activities as well as local practices that exist among clinical sites.
1:30 Leverage CTMS as a Powerful Decision-Supporting Engine This address discusses the goals and progress of this initiative,
Most companies today either have a CTMS or are considering as well as plans for the future.
using one to manage the day-to-day activities of their trials. • Hear about the goals of the caBIG® initiative and the
As the industry evolves, all the systems used to support clinical NCI vision of interoperability
development must evolve as well, including CTMS systems.
• Understand challenges and successes to date in
This keynote address analyzes the potential evolution of these
systems and offers insight into ways to ensure the CTMS enables deployment of the caBIG® Clinical Trials Suite and the
decisions critical to supporting future clinical trials. NCI Enterprise Services
• Discuss how CTMS can enable the next set of clinical • Learn the next steps with the caBIG® initiative and
operational efficiencies the NCI’s plans for restructuring of the NCI Clinical
IT Enterprise
• Transform CTMS for the future
David Loose, Contractor, NCI Center for Biomedical Informatics and
Simon Brooks, Product Champion, Integrated Clinical Research Suite,
Oracle Health Sciences Information Technology (CBIIT)
Bill Dyer, Contractor, NCI Center for Biomedical Informatics and
Karen Travers, Director, Product Strategy, Oracle Health Sciences
Information Technology (CBIIT)
FDA Address Academic Medical Center Address
2:15 Understand Potential Regulatory Issues and 4:15 A Site-Based Approach to CTMS
Inspection Expectations Clinical sites utilize CTMS systems to record data for clinical
CTMS systems can offer operational efficiencies for the trials specific to the study site, not aggregated multi-site study data
organization. However, understanding how the data needs to as in most sponsor-led trials. In that way, a disconnect exists in
be handled to comply with the FDA as well as what to expect how the information is entered and reported between the clinical
during an inspection is critical. This applies to any CTMS site and sponsor. This leads to challenges when sharing data in
system. This address discusses the regulatory challenges and study collaborations with sponsors because it requires sites to
expectations during an FDA inspection. Attendees are then manage their portfolio of research projects independent of the
invited to participate in a Q&A session with the FDA. sponsor. Over the last three years, Duke University has deployed
• Potential FDA regulatory issues when using CTMS a site-based CTMS in conducting trials. The CTMS is being
systems and its impact on FDA used for over 3,000 different clinical trials and tracking the study
* regulated clinical research activities visits of more than 60,000 study participants. The trials that
* marketing applications use CTMS range from small single-site research studies to large
* inspections multi-site trials. This site-based approach to CTMS provides the
site with tools to improve coordination of patient visits, capacity
• Hear case examples from the FDA
planning, billing integration, resource utilization, financial and
• Examine developing trends in clinical systems regulatory compliance as well as managerial reporting. This
* merging eClinical systems address discusses the site-based approach to CTMS and the
(i.e. EDC/CTMS/CDMS/IVRS) interrelationship with sponsors.
* use of EHRs • Hear an overview of Duke’s site-based approach
* home healthcare in clinical research to CTMS
* clinical data standards • Explore the disconnect between sites and sponsors
• Participate in an open discussion with FDA with data from CTMS
Jonathan S. Helfgott, Consumer Safety Officer, CDRH’s Division of • Analyze the capabilities of the CTMS and future
Bioresearch Monitoring, Food and Drug Administration plans for enhancements
Anthony Leiro, Manager, Business Architecture, Information Technology,
3:00 Networking and Refreshment Break Duke Clinical Research Institute (DCRI)

4. Considerations for CTMS Selection and Adoption CTMS System Implementation Strategies
5:00 Leverage Interoperability of the CTMS as the 9:00 Leveraging Implementation Experience from
eClinical Backbone for All Key Stakeholders Different Business Units for Smoother Transition
Managing programs and studies with configurable sanofi-aventis (SA) has been using a CTMS since the mid-
off-the-shelf software is a challenge. Those involved in 1990’s. However, Sanofi Pasteur (SP), its vaccine division, has
running a trial include the sponsor, contract research
only been using a CTMS since 2000. The SA implementation
organizations, ethics committees, local and central laboratories
and the investigative sites and patients themselves. All of had its challenges. In learning from them, SP has taken a
these users have their own needs — their own specific tasks to more cautious roll-out approach and has changed a few of
be recorded in, or guided by, ‘their’ software….ePRO, EDC, the processes involved with the implementation. To date,
IVR, etc. So, can we even conceive one “master system” to the implementation has gone much smoother and has started
coordinate milestones and data? This presentation shows with the capabilities of tracking milestones, written monitor
how a CTMS can be considered a ‘backbone’ for the entire visits and developing clinical reporting. Future plans include
eClinical framework. Interoperability of a CTMS is interfacing with clinical eDoc and EDC as well as integrating
discussed including: with finance. This case study compares and contracts the
• User workflow CTMS roll-outs of SA and SP, highlighting specific changes
• Dashboards in process that SP adopted as lessons learned. Also to be
• Intuitive use of a CTMS discussed are future plans for the CTMS.
• Notifications to various users
• Examine the CTMS implementations
• Tying data together of both SA and SP
John Humphreys, CTMS Product Director, Perceptive Informatics
• Analyze the changes made to ensure a smoother
5:45 Close of Day One CASE implementation for SP
STUDy • Hear future plans for SP CTMS
Daniel O’Connell, Manager of Monitoring Systems, Clinical Study Unit,
5:45-6:45 Networking, North America, sanofi-aventis
Wine & Cheese Reception William Dubost, Manager of Monitoring Systems, Sanofi Pasteur
Join colleagues and friends in a relaxed setting. Parambir Singh, Vice President, BioPharm Systems, Inc.
Photo by: Photolink / Getty Images
P
9:45 Customization of CTMS in an Outsourced Model
Day Two — Friday, March 25, 2011 A This panel discussion offers a look at Millennium’s customization
N of CTMS to support their study management needs, including the
7:30 Continental Breakfast development of data migration and data integration components.
E
As Millennium’s sourcing model changed during the
8:00 Chairperson’s Review of Day One L implementation of the tool, analysis of the impact on the system
Karen Travers, Director, Product Strategy, Oracle Health Sciences
requirements and business processes are also explored.
8:15 Analysis of the Decision Whether to Co-Develop a Moderator: Heather Wolff, Associate Director, Data Operations,
CTMS with an eCRO or to Buy an Existing Application Millennium: The Takeda Oncology Company
Ferring is a mid-sized pharmaceutical company specializing Panelists: David Roberts, Associate Director, Informatics,
in treating diseases mainly through peptide/protein pathways Millennium: The Takeda Oncology Company
and initiates about fifteen new phase I-III studies annually. Joe Coady, Lead Clinical Systems Developer,
Ferring’s fourteen-year collaboration with Target Health has Millennium: The Takeda Oncology Company
resulted in four NDA/MAA and other country approvals. Kevin Lloyd, Director, Clinical Business Operations,
In 2008, Target Health had co-developed a CTMS with an Millennium: The Takeda Oncology Company
international CRO. The advantages of that collaboration
are that there was a deep understanding of clinical research 10:30 Networking and Refreshment Break
operations as well the needs of pharmaceutical companies,
clinical research sites and regulators. Having outgrown its 11:00 Data Migration through M&A for Global System
homemade CTMS, Ferring evaluated several CTMS vendors
who would provide and/or build a suitable replacement.
Implementation and Deployment
This option was attractive because these systems require In 2009 Schering-Plough (SP) and Merck merged to diversify
a lot of resources, both to implement and maintain; and its product portfolio and result in a stronger market position.
Ferring was not in the software development business. Before the merger, SP and Merck utilized different CTMS
The system had to be user-friendly, flexible and easier to systems. A decision had to be made on which system to use
interface with their EDC system. This case study analyzes and then data had to be migrated to the chosen system.
that decision process, covers progress to date and offers insight This case study covers this process, highlighting key decision
into challenges and future plans. points with regards to data migration and roll-out approach as
• Maintain flexibility of the system well as discusses challenges faced throughout the process.
• Develop a growth plan as the company matures • Understand the resource requirements of the data
• Understand the risks involved with co-developing migration and user training
a system with a CRO versus an established
CASE • Analyze the process of Merck’s roll-out decision
STUDy CTMS vendor CASE
Jules Mitchel, President, Target Health STUDy • Learn future plans for CTMS capabilities
Silvana Cappi, MSc., MBA Executive Director, Biometrics, Mark Hill, Executive Director, Clinical Trial Operations, Merck & Co., Inc.
Ferring International PharmaScience Centre Chris Heider, Director, IT, Merck & Co., Inc.

5. “Very important forum to see what the industry is doing.”
— 2010 Attendee, Rob Stackhouse, Associate Business Systems Director, R&D Architecture, Shire Pharmaceuticals
Effectively Manage CTMS Post-Implementation cost of ownership (TCO) of the system be reduced without
compromising data quality, while increasing productivity?
11:45 Analyze the Management of Shared CTMS Data This case study discusses the wider initiative within GSK
between Sponsor and CRO regarding its clinical systems and steps taken towards
As a function of the outsourcing relationship, sponsors simplification of the CTMS.
off-load components of the clinical development process • Overview of the history of GSK’s CTMS
to CROs such as patient recruitment and site management, • Hear goals of the corporate-wide initiative
regulatory/submission management, etc. Inevitably, as a
part of this relationship, decisions regarding where and • Learn the results to date on lowering TCO
CASE through simplification
how the data is to be managed must be made. When the
STUDy
data is collected and managed using CRO systems, often Anthony Cavallo, Director, Operational Data Acquisition Support Services,
the sponsor needs the data to maintain in-house clinical ISS, CCSE, GlaxoSmithKline
development which is not outsourced. This data component
can be defined within a broader services contract or in some 3:15 Close of Conference
cases a contract is developed to specifically outline these
requirements. This case study outlines the export of data to
the sponsor to enable a distributed operational partnership.
Best practices for managing this process are discussed. In RecognItIon of ouR SponSoRS:
• Analyze various types of data export
• Design the data model CBI Research, Inc’s corporate sponsors represent select
• Ensure data transport protection companies that share a common mission: business advancement
• Examine the benefits and pitfalls of this process through thought leadership, strategic interaction and innovation.
CASE The companies represented below are proud contributors on this
STUDy • Discuss where the industry is headed
program and have carefully selected messaging, branding or
Steven W. Leypoldt, Associate Director, Business Analysis, IT, Quintiles
positioning statements to encourage the evaluation and investigation
12:30 Luncheon of quality products and/or services available. We applaud these
companies, as well as others that wish to join the conference,
1:45 Customizing a CTMS to Adapt to Changing Needs as important members of this event’s delegation.
In 2006, DSP Clinical Research worked with a vendor to
create a custom CTMS to meet their needs. Over the past About Our Presenting Sponsor:
four years, the CTMS had to be adapted on a continual basis
to meet the evolving needs of the organization. Payment
structure to sponsors changed from hourly to fixed-rate. DSP
implemented internal management processes to retain control
of the CTMS to better customize CTMS features. A strategy
was developed to ensure excellent customer service from Oracle is a leading strategic software solutions provider
the vendor. Although the system works efficiently, there to the health sciences industry. Oracle Health Sciences
have been challenges along the way and to date it still has its helps pharmaceutical, biotechnology, medical device and
limitations. This case study discusses the process from the healthcare organizations become the most successful in the
initial implementation through its adaptations. Challenges, world by offering the most innovative products and services
solutions and current limitations are also presented.
that deliver the most compelling customer and shareholder
• Examine the initial collaboration between DSP and value. Addressing industry requirements, Oracle provides
its CTMS vendor
comprehensive solutions including clinical trial management
• Analyze the adaptations made to the system and analysis, electronic data capture, adverse event reporting
CASE
STUDy • Discuss benefits, challenges and current limitations and pharmacovigilance and healthcare interoperability.
Brenda Reese, Vice President of Business Operations, Oracle partners with health sciences industry leaders to
DSP Clinical Research prevent and cure disease and enhance quality of life and
accelerate insights for better health.
2:30 Customization versus Simplification —
Getting Back to Basics to Lower TCO
Over the years, GSK has customized many facets of their Additional Sponsors:
CTMS system based on the needs of different therapeutic
areas, business areas, etc. Although customizations prove
to be useful, they are both expensive to support and can
present challenges in upgrading to newer versions. GSK
decided to simplify its CTMS, or get back to basics.
Can the same processes be supported using core system If you are interested in sponsorship or exhibit opportunities,
functionality? What level of customization is necessary please call Alexa Moore at 339-298-2107 or email alexa.moore@cbinet.com
versus configuration of the base product? Can the total
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6. R e g i s t e r b y J a n u a r y 2 1 , 2 0 1 1 a n d R e c e i v e $ 3 0 0 O f f o f Yo u r R e g i s t r a t i o n F e e !
• Utilize CTMS as the sole “master system”
CBi’s 4th annual forum on to coordinate milestones and data
• Examine implementation changes resulting from
Clinical Trial Management experience with one business unit to another
• Understand the benefits of a site-based approach
Systems (CTMS)
to CTMS
• Benchmark against other industry professionals
with peer-to-peer networking
Adoption, Integration and Management Solutions PlUS! Choose from Two Pre-Conference
to Maximize the Value of Investments Workshops — Thursday, March 24, 2011
A. Increase ROI B. Build Organizational
through an Bridges for Cross-Functional
March 24-25, 2011 • crowne Plaza Effective CTMS Collaboration and
philaDelphia, pa Training Program Decision-Making
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