State of Global Clinical Research trials


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This document details out a study conducted on the state if clinical trials. Read on to understand the emerging regions involved in clinical trials, challenges of outsourcing trials and more

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State of Global Clinical Research trials

  1. 1. The State of Global Clinical Research Trials© 2011 Wipro Ltd - Confidential
  2. 2. Agenda 1 Overview 2 A Wipro and UBM TechWeb Research Survey 3 Survey Findings 4 Key Takeaway2 © 2009 Wipro Ltd - Confidential 2011 © 2010 Wipro Ltd - Confidential
  3. 3. Overview3 © 2011 Wipro Ltd - Confidential
  4. 4. An Overview The pharmaceuticals, life sciences, and biotech sector • Intense competition and growing opportunities in the pharmaceuticals, life sciences, and biotech sector • Emerging markets are being seen as potential research and development sites as much as potential sales targets • Rising incomes in emerging economies increasing demand from reputed multinationals and manufacturers • Drug market in China,Valued at USD 33 billion in 2007 is expected to be valued at USD 126 billion by 2015 • Global sales of life sciences products outside of the U.S. expected to increase steadily in next few years, biologics drugs sales are booming Clinical Trials • Drug companies wishing to enter biologics market likely to face conducting clinical trials to gain regulatory approval • Clinical trials are a significant component of cost of developing new medicines and drugs. Thus the sector needs to tap ways to lower R&D costs and to reach new markets for patient trial supply and as a market • Clinical trials in emerging markets offers a potential solution for these objectives yet there are significant challenges – • Forging partnerships, supply chain support for the partnership, data gathering and analysis requirements for compliance with regulatory mandates of mature markets.4 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  5. 5. Survey5 © 2011 Wipro Ltd - Confidential
  6. 6. A Wipro and UBM TechWeb Research Survey Methodology In May and June 2011, UBM TechWeb conducted a study on the state of clinical trials, on behalf of Wipro. The survey included 116 biopharmaceuticals professionals who have begun or plan to begin conducting clinical trials in emerging markets. Percent distribution respondents by sector 38 22 19 16 5 Life Science Pharmaceuticals Biotech Biopharmaceuticals Biologics6 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  7. 7. Survey Findings7 © 2011 Wipro Ltd - Confidential
  8. 8. Emerging regions involved in trials Emerging Regions that will be involved in the trial (% of respondents) Route to enable global clinical trial infrastructure 11 Asia • 15% relying on a functional service provider hub-and- 46 spoke model, where CROs on-site are managed by hub 34 Eastern teams from major city sites. Europe South • 26% respondents say they are either acquiring local America infrastructure, building it up using their own resources, Southeast or using a third-party contract research organization 36 37 Asia (CRO) to deliver services for site monitoring, data Other management and other clinical activities. • 46% respondents target Asian market for • 41% are harnessing CROs as service providers in one clinical trials capacity or another • 59% respondents already conducting clinical trials in emerging markets • 7% are opting for systems integrators’ cloud-based • More than 50% respondents say they are services Somewhat-Heavily influenced by subject availability in nascent markets • 55% respondents say 60% trials still • These respondents also feel that outsourcing is an conducted mature markets increasingly attractive option8 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  9. 9. Challenges of Outsourcing Trials • Supplies for trials need to be maintained by first-patient-in date, failure can cause delays or disqualification of result Supply • Customs clearance to deliver materials, assuring appropriate packaging and labeling for outgoing specimens, securing depot facilities in-country for just-in- Logistics time delivery. 57% respondents say these challenges are significant. • Social or economic challenges, difficult-to-negotiate bureaucratic infrastructures that increase security or other handling demands. Others9 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  10. 10. Acceptance of data from emerging markets Concern regarding acceptance of data from NEGATIVES clinical trials conducted in emerging markets by U.S. /EU regulatory agencies • 86 % respondents say that they are somewhat or very concerned about how regulatory agencies in the U.S. and Western Europe react to data from emerging market trials 14 Somewhat • Questions over reliability and whether results could Concerned be extrapolated to North American audiences with different genetic backgrounds and lifestyles are being asked about clinical trials conducted outside the Very U.S.A Concerned POSITIVES 29 57 • 55% respondents feel timing of data availability was as good in emerging markets as in mature markets, 13% Not At All said it was better Concerned • Almost 50% respondents are satisfied with capabilities of emerging markets for trials, more that 30% even think that capabilities are highly advanced.10 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  11. 11. Cloud and Social Media Issues Faced in both emerging and mature markets can be addressed with an integrated suite of applications for clinical development Accessing clinical operations support and consulting services from third parties can be beneficial Cloud can facilitate business process integration, standardized electronic data management and data capture processes spanning multiple geographies % of respondents embracing cloud for hosting clinical trial data No plans 10 Embraced public cloud from third-party provider 12 Embraced both private and public cloud 20 Embraced private cloud in own datacenters 29 Future Plans 2911 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  12. 12. Cloud and Social Media • Respondents feel need to drive better understanding of data accumulated during testing phases for both home conducted as well as trials in emerging markets. • Social Media is playing a big role in gathering analytics to improve clinical trial processes. Organizations also using social media as a means to recruit patients for trials. Respondents (%) using/planning to use SM/online Challenges communities for real-time information or monitoring drug effectiveness • 67% of respondents who use/plan to use SM say that establishing an analytics approach and data capture methodology presents a challenge. 29 Yes 38 • 64% say they are concerned with how to integrate self-reported or observational data with controlled trial data. Maybe • 40 % expect that accounting for missing data (such as No when a patient drops out of a social-media enhanced 33 virtual trial) could be an issue.12 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  13. 13. Takeaways13 © 2011 Wipro Ltd - Confidential
  14. 14. Key Takeaways Pharma, life sciences, and biotech companies need to…. Take a proactive approach to navigate the changing nature of drug discovery on all its levels Reconstruct supply management to reduce weaknesses in database design and close gaps around clinical trial data integration Become more agile in analyzing data returns, to avoid safety concerns, Explore how new technologies, such as the cloud, may help them solve not just application issues across the globe but specifically speed implementations in remote regions14 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  15. 15. To read the complete report please visit the link below © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  16. 16. About Wipro Council of Industry Research Wipro set up the Council for Industry Research, comprised of domain and technology experts from the organization, to address the needs of customers. It specifically surveys innovative strategies that will help customers gain competitive advantage in the market. The Council, in collaboration with leading academic institutions and industry bodies, studies market trends to help equip organizations with insights to facilitate their IT and business strategies. For more information on the Research Council visit or mail wipro.insights@wipro.com16 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  17. 17. About Wipro Technologies Wipro Technologies, the global IT business of Wipro Limited (NYSE:WIT) is a leading Information Technology, Consulting and Outsourcing company, that delivers solutions to enable its clients do business better. Wipro Technologies delivers winning business outcomes through its deep industry experience and a 360 degree view of “Business through Technology” – helping clients create successful and adaptive businesses. A company recognised globally for its comprehensive portfolio of services, a practitioner’s approach to delivering innovation and an organization wide commitment to sustainability, Wipro Technologies has over120,000 employees and clients across 54 countries. For more information, please visit www.wipro.com17 © 2011 Wipro Ltd - Confidential © 2010 Wipro Ltd - Confidential
  18. 18. Thank you© Wipro Limited, 2011. All rights reserved.For more information visit www.wipro.comNo part of this document may be reproduced in whole or in part without the written permission of the authors.Wipro is not liable for any business outcome based on the views presented in this document. For specificimplementation clients should take advise from their client engagement manager. © 2011 Wipro Ltd - Confidential
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