Transparency
Market Research’s October 2014 report on the clinical trial management system
(CTMS) market indicates that the global CTMS space alone, worth just $844
million in 2013, is on track to grow at a 14% CAGR through 2019, when it will
hit around $1.85 billion. CTMS software platforms are used to manage, store and
analyze the huge volumes of clinical data associated with a given drug/device
and to circumspectly execute the requisite planning, preparation, and reporting
to carry out a clinical trial. Another report by Transparency Market Research,
also out in 2014, focused on the broader e-clinical solution software market,
which encompasses licensed enterprise, web-based and cloud-based deployments
spanning the CTMS, as well as clinical data management, electronic clinical
outcome assessment, randomization, trial supply management and safety solution
markets. That report indicates a similarly robust outlook for the industry,
with a projected CAGR of 13.8% through 2020, as the market swells from around $3
billion last year, to over $6.5 billion.
Growing
pressure on the pharmaceutical industry to shave time off the clinical trial
process and simultaneously increase drug productivity, as well as the rapid
emergence of e-clinical solution users like healthcare providers and contract
research organizations (CROs), have created serious tailwinds for the
e-clinical solutions software market. Moreover, the growing cost to take a drug
from conception through to FDA/EMA (or other relevant agency) marketing approval,
has steadily increased over the years and major e-clinical solutions sector
player Oracle (NYSE:ORCL) has documented the associated decline of U.S. and
Europe in terms of their percentage share of the global clinical trials market.
Japan,
China and India have all seen notable increases over the same interval, due in
large part to improved regulatory and patent expiration laws in Asia, as well
as lower overall clinical trial costs compared to the U.S. and Europe. Hence
the massive demand, particularly in western markets, for comprehensive
e-clinical solutions that can help cut time and money off the clinical trial
process, as well as the associated rise of CROs, to whom developers can
outsource their R&D work. The CRO market size alone was around $23.6 billion
in 2014 according to Industry Standard Research Reports, where growth has been
driven mostly by increasing R&D budgets ($245.7 billion in total) among
biotech, specialty, and generics companies, in addition to the demand for
cost-effective clinical trial outsourcing among new drug/device developers.
These
market conditions have created a huge boon for companies like DATATRAK (OTCQX:
DTRK), which serves the global clinical trials industry with their
comprehensive, unified e-clinical solutions platform and related services. The
company’s DATATRAK ONE® unified platform provides a single data source
architecture that powers all of DTRK’s e-clinical solutions, brilliantly
eliminating the often cumbersome and time consuming process of data
integration. Built for the cloud, this architecture, complete with a superbly
intuitive and easy-to-use interface, even allows for rapid mid-study changes to
be made on the fly, while also maintaining rock-solid uptime.
Because
the DATATRAK ONE architecture is a component-based platform of independent
solutions which are designed to integrate seamlessly in any configuration, no
matter what the specific deployment looks like, developers have full-spectrum
control over all aspects of a given clinical study, with real-time access to
all their clinical data. The DATATRAK ONE Unified Experience™ approach confers
numerous benefits in addition to industry-leading system reliability, intuitive
design and a unified data source, like improved site compliance, higher
granularity in the data sets, reduced trial complexity, and accelerated,
cheaper trialing, with a dramatic improvement in overall trial safety being a
natural bonus. Moreover, the DATATRAK Clinical Consulting Services (DCCS) team
brings the kind of trial type and phase spanning expertise needed for
developers to run a truly successful trial. With the DCCS team becoming an
actual extension of the development team and utilizing the same
customer-centric approach that has already made DTRK a preferred provider with
partners all over the globe, DTRK provides the software and the services
developers need to compete and thrive in today’s highly competitive clinical
trial market.
The
DATATRAK ONE architecture does it all: planning and management using the UX
CTMS™ component; design and deployment in one tool with the UX Trial Design™
component; data capture and delivery with the UX EDC & Medical Coding™
component; randomized patients and automated supply with the UX Randomization
& Trial Supply Management™ component; patient-driven data collection with
the UX Patient Data Capture™ component; individual case safety report
management with the UX Safety™ component; and robust user training, as well as
certificate tracking with the UX Training™ component. This unified architecture
also offers unprecedented capacity to be fully configured to the individual
user’s specifications and is accessible via single sign-on, delivering a vastly
improved user experience and the company genuinely considers its users to be
partners as well, providing a wealth of expansion programs that can help forge
an even closer bond under the DATATRAK CONNECT® banner.
The
company has a CRO-focused partner program, which supports CROs via a
collaborative effort that translates into further time and cost savings benefits,
complete with co-marketing opportunities and access to the DATATRAK sandbox, as
well as demo and bid defense support. The company also offers a technology
partner program focused on granting tech providers an interoperable channel via
access to the DATATRAK Exchange API (application programming interface), which
enhances overall usability and understanding for tech providers of the
architecture and its solutions, while simultaneously introducing them to
potential clients who are already keen on the significant benefits of the
platform. DATATRAK also does a highly unique reseller agreement program with
strategic partners in adjacent industries where their architecture has yet to
achieve a sizeable presence, like with China/Japan-focused NTT Data. This is a
particularly lucrative vector for DTRK given the outlook for the Asian
e-clinical solutions market and shows how spry the company can be when it comes
to penetrating new markets.
The
recent expansion in February of multi-year global enterprise agreements with
three top CRO enterprise partners, who have opted to extend their relationship
with DTRK and increase their global licensing capacity, is abundant proof of
how the advanced DATATRAK platform is actively reshaping industry expectations.
Cumbersome complexities like data integration, once considered unavoidable by
most developers, vanish within the DATATRAK ONE architecture and innovations
once thought impossible, like cross-study real-time data reporting, are already
fully integrated features of the platform. In addition to the recently added
cross-study manager, which provides tailored information support to each
individual researcher, granting extremely flexible reporting across 100 plus
fields, DTRK has added an automated information delivery scheduler, as well as
collaboration-facilitating file versioning, to their full suite of
enterprise-wide online data management tools.
Whether
clinical trialing is outsourced work being done at a CRO, or in-house
pharma/biotech or device development, DATATRAK prides itself on removing the
most difficult to contend with complexities and delivering truly revolutionary
advantages to the development process. This is particularly apparent with the
platform’s ability to do aforementioned mid-study changes in the field of
biopharma development, where the complex work never needs to come to a halt in
order to integrate new changes, an advantage which translates directly into
improved development cycle times and cost efficiencies. The advantages of the
DATATRAK architecture are also readily apparent in the device development
field, where the dynamic regulatory landscape presents unique challenges that
can be ably surmounted by DTRK’s fusion of proven technologies and industry
expertise, whether the specific goal is clinical trial data collection for
pre-market authorization approval, or keeping tabs on product usage once the
device has gone live.
Fully
aligned services to support their unified technology platform rounds out the
equation at DATATRAK. With an experienced arsenal of development teams, project
managers and trial designers at their disposal, as well as a complete solution
center and technology services under the DCCS umbrella, DTRK is a one-stop-shop
for clinical trial industry developers looking to up their game. The company
provides thorough training programs that are recognized throughout the industry
as being top notch, thanks in large part to the company’s extremely
knowledgeable learning solution specialists and the wide variety of hands-on
training that is available to meet any client’s needs.
Diving
deeper into the company’s services, we see that DATATRAK’s solution center is a
highly personalized single source contact which goes above and beyond the
traditional definitions of a help desk, providing customized, proactive help
that dovetails exceptionally well with the company’s learning center, which is
comprised of a knowledgebase covering every area of the e-clinical world.
DATATRAK’s experienced team of clinical data managers also help support the company’s
clients with full-service assistance, ranging from initial study builds through
to database closeout, and the company has a wealth of experience in trial
design as well, enabling clients to take the guess work out of preparing and
executing across the vast landscape of therapeutic areas and trial Phases.
Get
a closer look at DATATRAK by visiting www.Datatrak.com
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MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
