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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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©




     www.pharmatimes.com/subscribe | July/August 2010 | 43
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



    44 | July/August 2010 | www.pharmatimes.com/subscribe

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Pharmatimes article

  • 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
  • 2. es im aT m ar Ph © www.pharmatimes.com/subscribe | July/August 2010 | 43
  • 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 44 | July/August 2010 | www.pharmatimes.com/subscribe