the White Paper Delivering The Unified

Unified
Experience
JUNE 2014
DATATRAK ONE®: DELIVERING THE COMPLETE UNIFIED EXPERIENCE TODAY
Overview
Looking back
Dramatically increasing costs of clinical
trials are under scrutiny. The need to
develop more efficient treatments has
become the focus of the clinical trials
industry. Technology has emerged as an
optimal solution amid the ongoing effort
to reduce costs. The continued evolution
of technology has driven advances in the
eClinical solutions market with sustained
growth for nearly a decade. During this
time, the product offerings of typical
eClinical vendors have gone through
several distinct phases of development.
DATATRAK issued the seminal whitepaper
titled, “The EDC Value Proposition to
the Pharmaceutical Industry” at a time
when EDC vendors were still struggling
with a hesitant Pharmaceutical industry.
This study introduced tangible case-bycase evidence for the wealth of untapped
efficiencies in eClinical technology and
issued a call to action. The ensuing period
d of rapid innovation and diversification
within the emerging eClinical ecosystem
would form the base of the platforms we
recognize today.
Beginning with a broad base of individual,
specialized functionalities, many vendors
expanded
their
portfolios
through
acquisition and subsequent integration
of the disparate systems. Increasing
demands for clinical trial efficiency are
rendering the point solutions of EDC, IRT
and CTMS obsolete, and the integrated
software suites cumbersome. In order to
maximize the potential enabled by eClinical
solutions, they must be truly unified.
It was at this time that DATATRAK began
talking about the need for an end-to-end
unified eClinical platform, and not long
thereafter we delivered the first cloudbased eClinical platform on the market.
This release also held the distinction of
being the first solution on the market that
combined EDC and IRT, but more on that
later. Leveraging the responsive nature
of Cloud computing and implementing
Software as a Service (SaaS) models
created the opportunity to transform the IT
function across the industry
.
Pharmaceutical
companies
realized
however that an unhealthy portion of the
efficiency gained through renovation of
IT systems was lost with a new problem
arising;
contracting
with
disparate
vendors. Numerous service contracts
were logistically difficult to manage, but
more importantly, the proprietary database
architectures of these incompatible
products fractured clinical data across
numerous data silos. To reclaim some of
the functionality lost by operating across
data silos, companies were forced to
We now take a moment to paint a clear
state of the industry, and to reinforce
what should be meant by a unified
solution or system. The unified solution
DATATRAK has offered, from the beginning,
is fundamentally different from some of
our competitors’ integrated products.
The DATATRAK ONE® unified solution
empowers users to efficiently design,
deliver and manage clinical trials. When we
say a ‘unified solution,’ we mean a full suite
of products built to work together from
the first line of code, in order to reduce
inefficiencies and data risk.
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integrate these products in-house, resulting in
data duplication, migration and new sources
of risk.
Dealing with
Solutions
Integrated
Investing time and resources into a bridge
integrating disparate IT systems that
handle strongly-related data is wasteful.
Pharmaceutical companies seeking to shift
the burden of integration had only a few
courses of action available:
1) Wait for widespread adoption of data
standards, easing the task of integration.
2) Contract with eClinical vendors that provide
pre-integrated products as an enterprise
offering.
3) Locate a vendor that provided multiple core
functionalities.
Adoption of Data Standards
Unfortunately, in any technology industry, the
incentive for vendors to push for standards
is low. Vendors benefit from the ability to
“lock-in” customers by storing their users’
data in proprietary formats. By eliminating
the efficiencies of a one-vendor system,
standards expose dominant vendors to
the threat of competition from innovative
products developed by smaller, more agile
companies. The upcoming reauthorization of
PDUFA V by the FDA promises to lead to the
development of clinical data standards and
detailed implementation guides by 2017.
As a more agile company, DATATRAK has
embraced open data standards and the
challenge to innovate that comes with
it. To date, we are compliant with seven
Unified
Experience
June 2014
CDISC standards and implementations,
and DATATRAK currently sits on the CDISC
Advisory Council.
Outsourced Integration
With standards not yet established,
contracting with multiple eClinical vendors
to provide pre- integrated products emerged
as the most popular choice. As the industry
began embracing the option to outsource
integration, many single-product eClinical
vendors began the process of acquiring
products to complement their existing
offerings. Among the most notable is
Oracle’s acquisition of Phase Forward,
Perceptive’s acquisition of ClinPhone and
Medidata’s acquisition of Clinical Force.
While acquisitions provided the benefit of
a one-stop shop for clinical IT, it can also
come with the issues of product integration,
as the products built or acquired were not
developed, from the beginning, to work
together; many can still have data silos that
require migration and manipulation of data.
Migration and manipulation of data does
not represent a ‘unified solution,’ even if
sold under the umbrella of a single vendor’s
brand.
DATATRAK ONE® does not require data
migrations, as, from the first line of code,
all our individual solutions have been built
to work together without the migration and
manipulation of data
The Cost of Integration
The technology “bridge” that integrates
disparate systems must be built, and if
it is built by the eClinical vendor, this will
be reflected in its pricing scheme. But
construction is just the beginning; it requires
steady maintenance to ensure functionality
remains as other changes are made. This can
silently affect the cost of any development
effort that touches integrated parts.
Enhancements and bug fixes can often
change the underlying data models or the
manner in which they are accessed. When
this happens, the bridge that integrates the
disparate systems must also be updated.
In an integrated eClinical platform, this is
often reflected in the difficulty, downtime
and associated costs of providing bug fixes,
enhancements and completing change
orders. The complications created by
maintaining this bridge between products
not internally developed from the ground
up can be worked around so the consumer
may not have to deal with the headache
themselves, but they likely pay for it.
Integrated systems can suffer a blow to
both efficiency and reliability. Often data
transformations are performed using
expensive
extract-transform-load
(ETL)
procedures, to convert data pulled from
one system into a format recognizable to
another. In an eClinical suite, data may
need to migrate between modules quite
frequently, requiring data manipulation every
step of the way. More importantly, every
time data is transformed, it is exposed to
the risk of corruption. Errors do occur, and
the more moving parts that exist, the greater
the risk. The migration and manipulation of
data can make validation operations even
more crucial, frequent and expensive in an
integrated platform.
Data migration is commonly required by
eClinical vendors that deliver integrated
solutions when performing system upgrades,
bug-fixes, or mid-study changes and Protocol
Amendments. This is a costly procedure
both in fees and system downtime, moreso if errors are found during validation. A
study conducted by IBM found that, while
migrations are routine, 83% experienced
problems, with system downtime cited as
the leading problem. The additional costs
of these migrations are dependent on each
trial; however, the impact doesn’t end there.
The FDA presented findings that 43%
of their review time is focused on data
migrations. Eliminating data migrations in
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the clinical trial process can dramatically
reduce the review process.
Product development can be greatly limited
with integrated solutions. Because the
disparate systems are not built to work
together, a change in one system requires
additional time and investment in all other
systems that are touched, driving R&D costs
and timelines up. Difficulties such as these
are the reason your current vendor may offer
Single Sign-On functionality as a separate
product rather than a feature of its platform.
This functionality is itself likely an integration
of disparate login systems and the costly
design effort to build it is the reason it isn’t
offered for free.
Not all such enhancements are as simple
as the single sign-on. Over time, these
limitations can add up to a significant gap
of product innovation that is simply not
possible on an integrated software platform.
In the rapidly changing landscape of clinical
trials, limiting a solution’s ability to respond
and adapt to change can have difficult and
unpredictable consequences for both the
vendor and the user. The problem facing
many eClinical vendors is one of a rapidly
expanding perception of what the “core
functionalities” of their platforms should
be, and the shrinking space of what is
acceptable as a solution.
DATATRAK ONE® requires no data migrations,
so enhancements are focused on delivering
an ever-better product. Bug fixes are easily
implemented with no downtime. With no
data migration or manipulation, potential
errors are not only avoided, but valuable time
is saved. Our R&D expenditures support real
product improvements unencumbered by
the complexity of data silos and resultant
migrations. Because our product is built as
one unified solution, the only option is a
single sign-on.
Unified
Experience
June 2014
Multiple Core Functionalities
Identifying a vendor that offers a full suite of products, built to work
together under a unified structure eliminates the complexity and
risk of integrated solutions and their data silos. Ideally, cloud-based
service models should reduce silos by delivering purpose-built, endto-end infrastructures as a utility. In order to realize this benefit, the
infrastructure, the basic foundation of the system, must be part of a
unified solution.
‘fixes’ in the effort. Unified systems free the developer to focus on
new features that harness higher quality data, target the needs of
clinical trials, the people that run them and the patients who participate
in them, without the complexity of addressing technology bridges.
DATATRAK’s unified platform is fundamentally different from all the
other purportedly “unified” products that have cropped up in the last
year. In many cases, these vendors are simply misusing the term.
­
Putting the Right Foot Forward
‘Unified’ software products are not coaxed into working together, but
are built for each other. They utilize the same system for managing
data so all clinical data can be sourced across a variety of eClinical
applications. This unified architecture makes data migration obsolete,
delivering higher efficiency, reducing risk and providing better quality
data, not to mention a shorter review time by the FDA.
‘DATATRAK by contrast, foresaw the need for a unified platform and
built each product with the assumption that these were simply parts
of the greater whole. Today, DATATRAK ONE® offers a full suite of
products, which can be utilized individually, in pairs, in groups or as
a whole without complication. Think about the seven products as
light switches; you can simply turn them off or on and they will work
seamlessly together because they are all part of a unified solution.
DATATRAK delivers a unified eClinical solution that obviates data
migration, mid-study change downtime, or data synchronization
across systems. In our unified platform, all data is available across all
solutions, around the globe, immediately.
Because each of these products was designed as part of a unified
whole, they are specifically crafted to take advantage of this
relationship in ways that products that have been integrated (or
advertised as “unified”) as an afterthought, cannot.
If your vendor performs data migration, you are not using a unified
platform. Unified solutions are built on the same system architecture
in which data silos are rendered nonexistent. Unified solutions feature
a common interface, meaning no matter what product users might
be applying, the tools at their disposal all have a similar approach
and process. This keeps training simple, and it reduces timelines
and related costs. Unified solutions deliver a seamless eClinical
experience.
Unified solutions are, for DATATRAK, not a feature, but part of a design
philosophy. Our efficiencies of design and levels of reliability cannot
be replicated by competitors because the choice to build a unified
system has to be made from Day 1. There was a time not so long ago
when decision-makers in the Pharmaceutical industry had to make
the hard call to revolutionize the way that we conduct clinical trials. IT
has introduced powerful change to the industry, but this process does
not stop at the point- solutions of EDC, IRT or CTMS. The industry
is confronted with the new reality that a single end-to-end system,
a unified system, is needed to keep this giant engine running at full
steam. The unified DATATRAK ONE® is the only system purpose-built
to fulfill this need. This is the unified future available Today.
Defining Unified & Benefits
Unified products are far more flexible in the application of innovation.
Simplified and open communication channels between unified
products allow developers to build upon them without risk of breaking
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