This document provides guidance on planning and implementing a clinical trial management system (CTMS). It discusses signs that a CTMS is needed, benefits of a CTMS, preparing to explore CTMS options by analyzing needs and identifying key stakeholders. It also covers developing requirements, selecting a system, choosing an implementation partner, and post-implementation support. The goal is to select and implement a CTMS in a strategic manner to reduce costs, increase efficiency and productivity for clinical trial management.

1. IMPLEMENTING CLINICAL TRIAL MANAGEMENT SY
QUICK GUIDE TO PLANNING
YOUR CLINICAL TRIAL
MANAGEMENT SYSTEM
IMPLEMENTATION

2. ABOUT THE AUTHORParam Singh has been working in the life sciences industry his
entire career. As the director of clinical trial management solutions
at Perficient, Singh leads a highly skilled team of implementation
specialists and continues to build lasting relationships with clients. He
has a knack for resource and project management, which allows clients
to achieve success. Prior to joining Perficient (via BioPharm Systems),
Param guided the clinical trial management group at Accenture.
INTRODUCTIONClinical trials account for the majority of the cost in new drug development – a cost that is
constantly increasing. Not only are clinical trials expensive, but they are lengthy, complex
and highly scrutinized. Technology solutions play a significant role in helping life sciences
organizations oversee these critical tasks.
A clinical trial management system (CTMS) is a single centralized software system for
the management of all clinical trials. It eliminates disparate spreadsheets and databases
across trials, provides access to clinical trial information in real-time, and enforces
consistency of administrative, operational and financial aspects of trials across
an organization. The CTMS can be used by multiple business units or clinical
research divisions within a company, making it beneficial for sponsors,
contract research organizations (CROs) and academic medical centers.
This system can be implemented organization-wide using a big bang
approach or rolled out using a phased approach.
When an organization takes a strategic approach
to selecting an appropriate CTMS and
implementing it properly, the result is an
organization that reduces trial-related
costs, increases trial management
consistency and efficiency,
streamlines clinical trial
management and increases
clinical research productivity.
Perficient’s dedicated life
sciences practice specializes
in a full range of CTMS
services from consultation
through implementation.
CLINICAL TRIALS COST ARE
CONSTANTLY INCREASING

3. PLANNING YOUR CLINICAL TRIAL MANAGEMENT SYSTEM IMPLEMENTATION 3
SIGNS THAT A
CTMS IS NEEDED
Key indicators of the need for a CTMS include rapid
organizational growth or an increased clinical trial
pipeline as a result of a recent or planned merger,
increased number, size or complexity of trials, or the
introduction of, or increased participation in, global trials.
These situations typically result in a corresponding need to improve the efficiency and
turnaround times of clinical trials and to provide access to real-time trial information. If
a strategic plan is not put in place to address outdated trial management techniques, it
becomes increasingly difficult to quickly and accurately provide trial information.
The continued use of a homegrown management system or disparate methods of
study tracking can result in the inability to compare and contrast similar trials, lack of
standardization for information that is tracked, conflicting information for the same contacts
or organizations, and the inability to track metrics across trials.
BENEFITS OF
A CTMS
A CTMS enables you to enforce organizational
standard operating procedures and work
practices and eliminate individual approaches to
trial management. It also lets you utilize a single
database with access controlled by security roles and settings, and to use referential data
that results in less time spent on data entry and consolidation.
Internal and external integrations have become increasingly critical to today’s clinical trial
industry. Organizations want to be able to integrate trial management systems with other
applications such as internal customer master systems, document management systems,
electronic data capture, interactive voice response, clinical data management, safety and
pharmacovigilance, financial systems and more.
To justify and maximize IT expenditures, organizations want easy access to dashboard
reports that compile information from multiple sources. They want to reduce the amount of
double or triple data entries by having multiple systems talk to one another and share key
information such as contacts, accounts, addresses, subject visit information, adverse event
details and more.

4. PREPARING
TO EXPLORE
CTMS OPTIONS
A good bit of internal analysis and preparation must be performed to
build a business case for a CTMS. A company must first understand
its current trial management processes and identify various pain
points and perceived gaps. As you perform this analysis, take time to
really consider what role the new CTMS will play in the organization and which groups of
individuals and functional areas will be affected by the implementation.
You also should identify key business and IT resources for the CTMS project core team. At
a minimum, the core group should consist of a strong project manager, a business lead, a
technical lead and a validation/QA lead. Recognize that these individuals will be involved
in all aspects of the project preparation, implementation and roll-out. A key success factor
for the project will be the quality and quantity of communication that is provided within the
project team and to the end user community.
Before approaching potential CTMS vendors, you should create a system requirements
specification document, detailing and prioritizing system requirements by department and
functional area. Any potential constraints (e.g., virtual private network access, firewall
issues, etc.) and additional functions (e.g., migration services, integrations, etc.) also
should be identified and documented. Upper management will need a clear picture of
the key benefits of a CTMS, an estimated budget and timeline, and an idea of how the
expenditure will increase efficiency and reduce costs overall.
DEVELOPING A CTMS
SELECTION CHECKLIST
Your project team must become familiar with basic CTMS functionality and terminology
through various channels, such as internet searches and webinars. Identify potential
vendors and then research the functionality provided by their CTMS. At this point, you
should also consider the benefits of a CTMS accelerator versus an off-the-shelf product
(reduces implementation costs and timeframes). Read into industry recommendations, visit
conferences, and comb vendor websites and product data sheets, paying close attention to
the following characteristics:

5. PERFORMANCE
A CTMS should demonstrate consistent performance and response times under repeated
tests of various real-world scenarios. This is true for day-to-day performance, querying and
reporting. Users don’t have time to wait for the system to respond to various commands.
The software manufacture should incorporate tools and techniques to minimize any
anticipated performance issues.
SCALABILITY
When a company starts performing an increased number of clinical trials, the CTMS needs
to be expandable, (scalable), in order to handle the increased amount of data tracking. It
also must handle larger numbers of concurrent users. It is important to know any potential
costs associated with scaling up a CTMS, such as adding additional servers, more user
licenses, etc.
KEY CONSIDERATIONS DURING CTMS SELECTION
A robust CTMS is one that can support most, if not all, trial management tasks from
feasibility and study startup to subject tracking and provider payments. It also is one
that has been coded properly. The system should not completely go down if one issue is
experienced during day-to-day production use.
When looking at various systems, you will need to find out what types of customizations, if
any, are both possible and necessary. While the flexibility provided by a highly customizable
system may be tempting, try to exhibit restraint for the initial implementation. Keep in mind
that each customization is going to increase the cost of your implementation and extend the
project timeline.
Determine what, if any, data will be migrated from current systems or spreadsheets.
Depending on the data source, the data to be migrated will need to meet specific format
criteria, which can be a time-consuming exercise
especially if data will be migrated from multiple
sources. In addition, it is always good practice
to clean the data prior to migrating it to a new
system.
In today’s IT environment, most CTMS solutions
can be integrated with multiple systems. Several
organizations have found that it is best to first
implement the base CTMS and then perform
one or more integrations as separate phases.
This method provides the basic functionality of
a CTMS to the end users more quickly. It is also
recommended that you analyze the integration
method proposed by each vendor. Some
methods are more practical than others in that
they can be re-used with other applications or
vendors.
PLANNING YOUR CLINICAL TRIAL MANAGEMENT SYSTEM IMPLEMENTATION 5

6. THE CTMS CAN BE USED BY MULTIPLE BUSINESS
UNITS OR CLINICAL RESEARCH DIVISIONS WITHIN A
COMPANY, MAKING IT BENEFICIAL FOR SPONSORS,
CONTRACT RESEARCH ORGANIZATIONS (CROs) AND
ACADEMIC MEDICAL CENTERS.
CHOOSING AN
IMPLEMENTATION
PARTNER
A software vendor may have the expertise to also be the implementation partner, but be
sure to explore other options as well. A company that specializes in CTMS implementations
will often be more cost-effective and provide a wider range of implementation services that
include integration and migration. In addition, a reputable implementation partner will be
able to guide you through the computer system validation process if it is required by your
organization. Keep in mind that your implementation experience will only be as good as the
implementation partner that you select!
CONSIDER POST-IMPLEMENTATION
SUPPORT
Each CTMS vendor and implementation vendor should have
affordable and flexible options for post-implementation support.
This type of support is typically used when an internal support
system is not able to resolve a user or system issue. The
external support options should include live phone support,
email, remote access capabilities and knowledge base
availability. The goal of an external support system
should beto resolve system issues quickly and effectively.

7. CTMS EXPERTISE,
AT YOUR DISPOSAL
Perficient has a dedicated team that specializes
in Oracle’s Siebel CTMS. We provide a wide
range of services, including cloud or on-premises
implementations, upgrades and integrations. Due
to our deep expertise, we developed ASCEND,
a pre-configured and enhanced version of Siebel CTMS. Ascend accelerates the
implementation timeline and saves costs, since the system contains many frequently
requested configurations right out of the box. Our services and solution accelerator have
been leveraged by pharmaceutical, biotechnology and medical device companies, in
addition to CROs and academic institutions.
TO LEARN MORE ABOUT PERFICIENT’S LIFE SCIENCES PRACTICE, VISIT
HTTP://WWW.PERFICIENT.COM/INDUSTRIES/LIFE-SCIENCES
PLANNING YOUR CLINICAL TRIAL MANAGEMENT SYSTEM IMPLEMENTATION 7

8. STAY INFORMED
Keep current with the
technology trends, issues
and experts by following
our life sciences blog.
blogs.perficient.com/
lifesciences/
UPCOMING AND ON-DEMAND WEBINARS
Perficient experts frequently host technology webinars to discuss
the latest enterprise technology trends and share best practice
recommendations. All webinars are complimentary.
perficient.com/Webinars
CONNECT WITH PERFICIENT LIFE SCIENCES:
PERFICIENT.COM LINKEDIN.COM/COMPANY/PERFICIENT @PERFICIENT_LS
Visit us at: www.perficient.com or email us at: LifeSciencesInfo@perficient.com
ABOUT PERFICIENT
Perficient is a leading information technology consulting firm serving clients throughout North
America. We deliver business-driven technology solutions that enable our clients to reach new
markets and increase revenues, strengthen customer relationships, reduce operating costs, increase
productivity and empower their employees. Perficient is world-class talent, delivering world-class
technology, on time and on budget.
Perficient’s life sciences team has extensive experience in the implementation and integration of
the most widely used and highly sought-after clinical and pharmacovigilance software applications.
We also specialize in the implementation of the leading digital signature solution for the life sciences
industry, which can be implemented as a stand-alone application or integrated with various clinical
trial software applications.
DELIVERING BUSINESSVALUETO OUR CLIENTS
Our services and industry tools enable sponsors and research organizations to get their systems up
and running quickly. The results are faster time to value, low and predictable costs, and a better fit for
each client’s business.