The e-clinical sector is evolving rapidly, with companies like Oracle and Phase Forward leading the charge in integrating technologies for clinical trials. As the industry is projected to grow by 10% annually until 2013, the emphasis is shifting towards comprehensive solutions that streamline processes and improve data interoperability. This convergence of services highlights an industry trend towards end-to-end integrated solutions to enhance efficiency in drug development and clinical trial management.

1. CLINICAL
E-clinical providers are fighting to reposition and
re-assert themselves amid changing customer needs
and a dizzying pace of technological change.
Peter Mansell reports
Tilting in a new
es
direction
im
T
he eClinical sector has “the industry’s most comprehensive pure technology companies in clinical
expanded far beyond its roots in suite of software applications for development is limited.
electronic data capture to offer clinical development”. Now, bolstered Chief executive officer of
technology platforms across by its acquisition spree, the company’s PharmaVigilant Jim DiSanti’s view of
the spectrum of clinical trial design,
execution, monitoring and analysis.
In fact, the industry has managed
to weather what has been described
as “frankly the worst period of
pharmaceutical development in probably
aT
integrated capabilities stretch all the way
from Phase I trials through regulatory
filing to post-approval monitoring.
Yet if this promise of ‘end-to-end’
services beyond the scope of clinical or
even post-marketing trials throws down
integration is that “there are people who
are doing it and people who are talking
about it”. When he set up PharmaVigilant
in 2005, the vision was “not just to build
another EDC company but to build what
we felt was a truly integrated technology
two generations” partly because the new a gauntlet to Oracle’s competitors, they company”. The contrast is “an amalgam
technologies, such as remote monitoring, remain sanguine. of different systems that people integrate
m
project management and global site – which is really no different from what
enrolment, are starting to infuse clinical The value of integration? pharma has been buying for decades”.
operations. This convergence between These “cobbled together” systems will
So while technology sectors technologies and services is what eventually stumble in the market,
generally experienced “some decline” would be expected in any efficient, he believes.
ar
during the recession, the impact “was data-intensive business, says Kent, who Phase Forward had “a fairly robust
not significant in the eClinical space, defines the current landscape as “moving footprint of integrated solutions to begin
and purchase of these solutions has from a series of best-in-class solutions in with” and has used acquisitions to “pull
continued”, says Steve Kent, president each of the verticals to a market where in the pieces they did not have”, DiSanti
of Parexel subsidiary Perceptive these solutions converge and integrate”. notes. Oracle, on the other hand, had
Informatics. Indeed, the overall market This trend “is clearly underway in the already “bought in a lot of disparate
Ph
for eClinical solutions is projected to clinical trials technology market, and systems” and Phase Forward “is just
grow at 10% a year through to 2013. is a driving force behind the rapid another piece of that”.
But what did look like a potential consolidation we have seen over the past It is certainly more difficult to
game-changer, and a harbinger of two years”, but he stresses the company’s integrate disparate technologies,
further consolidation for eClinical belief that the market opportunity for “since the underlying architectures are ›
players, was software giant Oracle’s
recent acquisition of Phase Forward, the
US-based provider of data management What is eClinical?
solutions for clinical trials and drug Originally, eClinical was used to refer to any technology application in use within a
©
safety. One striking element of that clinical trial. The usage of the term eClinical has evolved to a more specific context
deal was the speed and determination focused more on business process than on individual technologies.
with which Oracle – traditionally an “IT Increasingly, the term is being adopted to convey the concept of integrated
technologies utilised in clinical trials – technology products working together as
installation company” – has muscled solutions, sharing data, eliminating duplication of activities, and streamlining the
into the eClinical space. use of multiple technologies for end users. Therefore, an example of an ‘eClinical
Oracle only set up its health sciences solution’ is the combination of EDC and interactive voice response systems where
global business unit in June 2008. By common data are shared in a way that eliminates the need for users to enter
the same data or perform the same action in both applications. The shift in the
March 2009, when it bought safety defi nition of eClinical has been a natural part of the industry’s evolution to seek
solutions provider Relys International, better ways to utilise multiple technologies together within a clinical trial.
the company already claimed to have (Source: Wikipedia)
42 | July/August 2010 | www.pharmatimes.com/subscribe

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3. CLINICAL
Case study Online:
Oracle gathers pace in healthcare www.pharm
atimes.
The ultimate ambition in realising sure the Phase com/clinical
The acquisition of Phase Forward gives news
a fully integrated environment is to III data that for free elerts
Oracle a lot more to play with, notably
and news
a SaaS (Software as a Service)-based streamline workflow and support real- brought your
searches
integrated clinical research suite that time data interchange to help companies drug to market
incorporates electronic data capture,
make better, faster decisions that mean is [supplemented
interactive response technology, data
and statistical analysis platforms, trials are run more efficiently. In a with] lots more
safety services and electronic patient- recent survey of biopharmaceutical data related to an open-market sell,
es
reported outcomes. professionals by Perceptive Informatics that you’re constantly evaluating what’s
With the Health Sciences Global most respondents (71%) said they happening – particularly the safety
Business Unit it set up in June 2008
have integrated, or are in the process aspects,” Bird explains.
already encompassing clinical
trial design and management, of integrating, a number of systems And in the wider healthcare context,
healthcare data, clinical and to improve processes and overall Birch notes that “right now there’s a
healthcare analytics, and healthcare
im
trial data accuracy. A smaller group disconnect between the clinical trial
interoperability solutions, the
of respondents (21%) claimed to see process and dealing with real patients
acquisition was also couched in a
broader healthcare context. the value of integrating their systems, who have other healthcare needs. Is
Phase Forward and Oracle products but had not yet done so. Only 8% had there a way for us to take the benefits of
would both accelerate delivery of developed established integration eClinical data management and move
innovative therapies and help control standards they expected technology from the testing stage to the clinical
healthcare costs by giving customers
vendors to adhere to. stage?”he asks.
“greater insight into patient outcomes
during drug development and during Though consolidation “is a natural
‹
the provision of healthcare services”,
Oracle declared.
different”, Kent acknowledges. “Even
if technology pieces are acquired, the
effort to make them interoperable and
aT
From tactical to functional
What is now emerging in eClinical,
Kent believes, is “a genuinely convergent
solution” whereby the individual
functionality of the old application
silos becomes less important and the
event in any industry that mirrors ours”
the true value of these strategies remains
uncertain. But what is clear is a bottom-
up approach is no longer an option
in the fast-paced world of eClinical.
“The systems in the market today from
aligned to a common endpoint takes integration between the different the larger established vendors are
time and diverts development effort components and the attendant workflow sophisticated applications with many
m
away from other enhancements to the becomes far more critical in how useful thousand years of software engineering
product line”. the system is to the user. in them,” Kent comments, making it
The “rhetoric” coming out of Oracle- This also suggests the sector may unlikely that any company starting
Phase Forward is of “pulling together the be tilting in the same direction as the from scratch will be able to develop new
data within a clinical trial and making CRO market by graduating from tactical innovative functionality that will enable
ar
it into one-stop shopping”. To date, outsourcing to functional and strategic it to catch the leaders.
though, Oracle has really taken a vertical relationships along the lines of the With the pharmaceutical market
approach to the clinical trial process, Lilly-Covance tie-up. witnessing a unique set of challenges in
Datatrak’s Laurence Birch, chairman Certainly Birch believes a more R&D and clinical, there would appear to
and chief executive strategic emphasis will come to be no better time for eClinical providers
officer contends. eClinical. Its role, he says, is to adapt to to show how they can assist in pharma’s
Ph
the marketplace: “We’re a back- pursuit of the ultimate in clinical trial
office operation… the people who efficiency. PT
are developing the drugs and
the medical specialists who are Peter Mansell is an independent
developing the testing, they’re at healthcare writer
the forefront… First find out how
the sponsor companies want to
manage their trials.” On the web
Kent regards • Parexel back on the growth train
©
strategic relationships in in third quarter
the eClinical space as a • Oracle takes Phase Forward for
US$685 million
natural outgrowth of what is happening
• Oracle-Relsys combination
with CROs; essentially this means closer
will offer “end-to-end” safety
integration between service provision solutions
and technology, allowing firms to • Datatrak Q4 operating losses rise
generate more benefit to sponsors. but backlog improves again
Part of bringing greater benefit • EDC now used in nearly 60% of
means extending forward into the post- clinical trials
approval market. “You want to make www.pharmatimes.com/worldnews
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