Pharmatimes article


Published on

E-clinical providers are fighting to reposition and re-assert themselves amid changing customer needs...article by Peter Mansell, interviewing Steve Kent, President of Parexel and Laurence Birch, Chairman of DATATRAK International.

Published in: Business

Pharmatimes article

  1. 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 |
  2. 2. es im aT m ar Ph © | July/August 2010 | 43
  3. 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 44 | July/August 2010 |