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TranSenda
White Paper
Business
Process Management and the
Clinical
Trial Process
CONTENTS
Introduction
.......................................................................................2
BPM
Basics .........................................................................................3
BPM
and Clinical Trials........................................................................4
Summary............................................................................................5
Summary
This
white paper explores many of the issues faced by both small
and large life sciences companies when attempting to apply
technology to the clinical trial process. It introduces
the concept of business process management (BPM) and how
this technology differs from traditional software applications.
Additionally, it provides examples of BPM applications in
the clinical trial process and explains how life sciences
companies of any size can take advantage of the benefits
provided by this
technology.
Introduction
The
drug approval process requires a substantial investment
regardless of your organization’s size. The importance
of drug safety and efficacy validation is the same whether
you have the financial resources of a major pharmaceutical
company or those of a biotechnology startup. This paper
addresses how a BPM-based clinical trial technology empowers
the smaller life sciences company with the ability to grow
and integrate clinical trial processes throughout the company’s
lifecycle when and where needed. Additionally, it discusses
how this technology can help established organizations integrate
their clinical trial processes throughout their enterprise,
extending system functionality and optimizing workflow.
Due to limited technology and IT staff resources, many small
companies in early phase trials rely on the expertise and
resources provided by outsourced providers (CROs). These
services, while expensive, are still preferable to the time-consuming
and often distracting process of building an internal clinical
trial process and data tracking infrastructure. Many organizations
at this stage prefer to dedicate their limited resources
to drug discovery and development, not IT systems support
and training. As these companies grow and their participants
move to later-stage trials they are more likely to be in
a position to hire a larger IT staff and acquire systems
capable of supporting certain clinical functions. Unfortunately,
due to a lack of sufficient or flexible entry level clinical
trial support applications, organizations are often forced
to do one of the following:
1. Purchase enterprise systems designed (and priced) for
companies withbroader needs and greater support resources.
2. Purchase less expensive, shrink-wrapped applications
that often fail to provide any measurable benefit due to
lack of features or configurability
3. Develop custom solutions. This approach not only taxes
existing resources, but can also result in systems with
limited functionality and expandability and, unless properly
documented, can be crippling if those who wrote the application
leave the company. As a sponsor’s needs continue to
grow so too do their clinical and operational system requirements.
At this point sponsors are faced with the often impossible
challenge of integrating the various systems they’ve
purchased along the way. Because nearly all existing clinical
support applications were developed using proprietary, hard-coded
methods, integrating them often requires the services of
third-party integrators who employ custom, and expensive,
approaches to “glue” applications together.
What sponsors are left with is a multi-vendor patchwork
of systems and custom code that costs a fortune, drains
untold amounts of IT and cross-functional resources, and
is nearly impossible to modify. Is it any wonder sponsors
are reluctant to implement software solutions?
So what’s the solution?
The industry is crying out for solutions that can
mirror their own life cycle and development processes. Systems
that can start small, addressing the needs of sponsors at
a particular time and that are easily extended. Systems
that are flexible and quickly modified, not just in look
and feel, but in their core logic and functionality. And
systems that quickly and natively integrate with other clinical
and cross-functional applications such as those employed
by Manufacturing, Accounting, QA, and Sales & Marketing.
Sound too good to be true? Until recently it was. Many in
the Life Sciences industry are still unfamiliar with a new
application paradigm that is rapidly being adopted by other
industries to solve their process challenges. This paradigm
is commonly referred to as Business Process Management (BPM).
BPM
Basics
“BPM
is the general term for the services and tools that support
explicit process management (such as process analysis, definition,
execution, monitoring and administration).” 1 To understand
BPM, we must first understand what a “business process”
is. For the purposes of this discussion, a business process
is defined as the “process by which information (data)
is transformed as it moves between systems and individuals
to provide a desired result for the business.” For
example, ordering and fulfilling a book at an on-line bookstore
involves the interaction of numerous systems and people,
but can be considered an end-to-end business process. Consider
that standard software applications are made up of hundreds
of modules, linked together by the software vendor to provide
a specific set of functions. Further, consider that these
“silo” applications are dispersed throughout
an enterprise, all dependent upon multiple software vendors.
Modification to the “wiring” of these functions
has to be done by the software vendor, requiring development
time and an expensive upgrade on the part of the customer.
Imagine if it were possible for a business analyst, or “process
designer” without programming expertise to link these
software modules together using a graphical tool to implement
a business process. No software code needs to be written
to achieve this increased functionality. Business processes
could be quickly added or modified as dictated by business
needs, as opposed to being tied to a vendor’s upgrade
schedule or a lengthy internal development cycle. This is
what TranSenda’s BPM technology provides – the
ability to build out processes as the business evolves.
To achieve their inherent flexibility, BPM solutions are
often based upon servicesoriented architecture and open
standards, such as XML. Some offer preconfigured components.
“These tools are also targeted at increasing the efficiency
of a specific application by enabling systems to work together
better.”2 TranSenda is the only BPM vendor to offer
preconfigured libraries of “process modules”
for health care and life sciences. Furthermore, by enabling
its users to “plug-and-play” these modules in
various combinations and then customize them with their
own proprietary business rules and processes, TranSenda
provides its customers with an unprecedented level of
control and ownership.
1
A BPM Taxonomy, Creating Clarity in a Confusing Market,
page 1, Gartner Group, May 29, 2003
2A BPM Taxonomy, Creating Clarity in a Confusing Market,
page 4, Gartner Group, May 29, 2003
BPM and Clinical Trials
So what does this have to do with clinical trials?
Clinical trials are business processes that involve the
coordination of data throughout the organization. Of course,
there are special requirements in terms of auditing, security,
and data integrity that also ust be taken into account.
But, a BPM-based clinical trial solution that incorporates
these special requirements will provide a platform from
which clinical trial processes may be added as the organization
grows, and as requirements are understood. This contrasts
with having to commit to a system that may not meet future
needs, especially in terms of integration with the rest
of the organization. Let’s consider an example. A
small biotechnology company currently uses a paperbased
clinical trial process and they are approaching the increased
data throughput of Phase III of their trial. They want to
begin by automating their selection and registration process,
and controlling their paper-based processes. Using BPM-based
clinical trial software, the registration and selection
rules can be implemented and updated with a graphical editor,
much like building a high-level flowchart. Business processes
to route scanned documents for review and approval can also
be implemented in the same fashion. As the company’s
needs grow, an EDC business process can be added. For those
who have already invested in a clinical trial system, BPM-based
platforms provide a means to interconnect with other enterprise
systems. For example, a situation may occur where a biopharma
embarks upon trials for other indications, requiring coordination
of clinical trial processes with commercial manufacturing
and drug delivery applications. This requires the coordination
and movement of data between the clinical trial system,
a logistics system, and an ERP system, which can all be
defined as business processes. The leading EDC vendors have
built impressive applications and many offer what they call
integrated suites. However, by nature of their hard-coded,
applicationcentric design, the reality is that these applications
are unable to be seamlessly integrated across the suite,
let alone the company’s entire organization. In the
situation cited above, the company will likely have to wait
for their vendor to upgrade its offering or resort to a
custom development project. Application or datacentric systems
are simply not designed to be agile, whereas rules-based
BPM solutions are. This situation begs for BPM, especially
if that platform is designed specifically
for clinical trials.
Summary
A
process-centric clinical trial system with BPM provides
the optimum infrastructure to manage and control critical
business processes, and integrate with enterprise systems.
Applications and business logic can be built out as needed
by the organization. TranSenda is one of only a select few
that has taken a BPM platform and adapted it for use in
the Life Sciences market. Over the last two years, we’ve
collaborated with many of the industry’s largest players
to create application libraries as well as process and interface
templates that bridge the gap between marketsavvy traditional
clinical support applications and powerful, but market-agnostic
pure play BPM vendors. The result is an industry-focused
solution with flexibility and expandability that outperforms
anything currently available in the market. |
