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Clinical Development Outsourcing Models
 

Clinical Development Outsourcing Models

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ISR’s report explores how often various outsourcing models are used, sponsor satisfaction with models, the driving forces behind using each type of model, as well as which situations would be likely ...

ISR’s report explores how often various outsourcing models are used, sponsor satisfaction with models, the driving forces behind using each type of model, as well as which situations would be likely to cause a sponsor to deviate from their standard outsourcing design.

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    Clinical Development Outsourcing Models Clinical Development Outsourcing Models Document Transcript

    • EW PR EV I Sole Source InSourcing Preferred Provider Compound or Program Based Functional Service Provider Fee-forservice Clinical Development Outsourcing Models Info@ISRreports.com ©2013 Industry Standard Research www.ISRreports.com
    • act with confidence Report Overview ISR’s report explores how often various outsourcing models are used, sponsor satisfaction with models, the driving forces behind using each type of model, as well as which situations would be likely to cause a sponsor to deviate from their standard outsourcing design. Methodologies: ISR conducted 100 quantitative surveys with respondents who: • • • Currently work at a pharma or biotech company with annual R&D expenditure of at least $100M …Have responsibility for outsourcing clinical trials …and are knowledgeable about their company’s clinical development outsourcing model 74 Charts and Graphs 71 Q4, 2013 Pages Publication Date Report Structure: 1. Executive Summary 2. Clinical Development Outsourcing Dynamics • • • • • • Distribution of outsourcing budget by activity Drivers of outsourcing model selection Current volume and anticipated growth/decline by outsourcing model Preferred service provider type by phase of development Outsourcing difficulties Roles and responsibilities that influence service provider selection 3. Satisfaction, Selection, and Use of Outsourcing Models • Analysis of each outsourcing model evaluated including the current and future anticipated volume of studies, satisfaction with that model, and reasons to use that model 4. Future Predictions • Likelihood to deviate from current model in specific scenarios • Likelihood to change service providers based on trends 5. Study Data Outsourcing Models Evaluated: • Fee-for-service • Preferred Provider • Functional Service Provider • In-Sourcing • Compound or Program Based • Sole Source Learn how you can use this report. www.ISRreports.com ©2013 | Preview of: Clinical Development Outsourcing Models 2
    • act with confidence What you will learn in this report: • • • Benefits for each major outsourcing model Percentage of outsourcing volume each model currently represents and how this will shift by 2015 Sponsor satisfaction, reasons for selection, and details for how each model is used How you can use this report: • For Study Sponsors: Identify which outsourcing models other organizations are utilizing, their level of satisfaction, and their reasons for choosing that model. • For Service Providers: Define your marketing and operational strategy by understand your customers’ current and future outsourcing needs and why they choose certain outsourcing models. Valuable for: • • • • Outsourcing Project Management Clinical Operations Clinical Service Providers Up next: Full table of contents and sample pages www.ISRreports.com ©2013 | Preview of: Clinical Development Outsourcing Models 3
    • act with confidence Table of Contents Full table of contents and additional sample pages available in the full preview, free on our website: http://www.isrreports.com/product/clinical-development-outsourcing-models/ www.ISRreports.com ©2013 | Preview of: Clinical Development Outsourcing Models 4
    • act with confidence Sample Page: Report Introduction Introduction act with confidence Introduction One way to think about the Russian clinical trial and pharmaceutical environment is When it comes to outsourcing clinical development activities, there is a myriad to think of that can be employed, traded from using only one provider for of models the country as a publicallyrangingpharmaceutical company� If you were all leafing through a prospectus or an vendor for each individual need. a comoutsourcing needs to selecting ainvestor presentation, you would find Certainly, pany with strong macro fundamentals, historic each sponsor organization must decide for growth, inconsistent(or set of models) itself what model performance, and some regulatory uncertainty� In short, Russia has many of the same characterbest suits mid-stage pharmaceutical company� And, if you take a portfolio theory istics as a its clinical development needs. approach to investing, you would likely want to invest some portion only one or ISR has found that most companies do not limit themselves toof your assets two in Russia� Why? outsourcing models. The average sponsor in this survey uses four different outsourcing models and will mix and match which model is to be used based ↑ Macroeconomics: Russia is the world’s 10th largest economy on the need. Sponsors, however, may have different reasons for using the same ↑ International recognition: Joined the World Trade Organization (WTO) in 2012 model. One sponsor may choose to use preferred provider model to achieve reduced costs while another might ~$240B trade model to achievefuel reserves ↑ Positive balance sheet: Russia has employ the surplus from fossil a deeper relationship with each provider. ↑ Focus: Putin announced $3�9B plan aimed at having 90% of medicines to be This locally produced by 2020 often various outsourcing models are used, sponsor research explores how satisfaction with models, theMedicines Insurance System (Aug 2012) is to be in ↑ Reimbursement structure: driving forces behind using each type of model, as well place by 2020 that will include a tiered rate of reimbursement, depending on their as which situations would be likely to cause a sponsor to deviate from standard outsourcing design. improve access to medications the nature of the illness, and ↑ Growth: Russian pharmaceutical market has been growing 17% annually since 2005 ↑ Untapped potential: Many patients are treatment naïve, offering opportunities for clinical trial patient recruitment ↓ Uncertainty: Regulatory environment and customs practices are unstable and unpredictable ↓ Difficult: In 2012 the World Bank ranked Russia 122nd on their list of economies by ease of doing business, 21 spots below China ↓ Skills: Finding highly qualified healthcare professionals can be difficult ↓ Protection: IP protection is concerning www.ISRreports.com ©2013 | Russia: Clinical Development Country Profile 7 www.ISRreports.com ©2013 | Preview of: Clinical Development Outsourcing Models 5
    • act with confidence Sample Page Executive Summary: Clinical Development Outsourcing Dynamics act with confidence Preferred Service Provider Type by Phase Respondents prefer to useuse small, niche CROs forPhase I trials; mid-size, fullRespondents prefer to small, niche CROs for their their Phase I trials. service CROs for Phase II trials;pressures global CROs for their Phase III and Phase IV Company policies or other and large, may not always permit respondents trials. Company policies orof CRO but the may not always permit respondents to use to use their first choice other pressures chart below shows the type of their first choice of Provider Type by Phase use if the choice CROs that respondents Preferred Service CRO but the chart below CROs that respondents would prefer to shows the type of were completely would prefer prefer toifuse small, niche CROs for their Phasetotrials; mid-size, fullRespondents up to them.to use the choice were completely up I them. service CROs for Phase II trials; and large, global CROs for their Phase III and Phase IV trials. Company policies or other pressures may not always permit respondents to use their choice were completely up below shows type of service providers would “If thefirst choice of CRO but the chart to you, whatthe type of CROs that respondents you would prefer to use if the choice were completely up to them. choose to help your organization conduct clinical trials?” (Base = 100) “If the choice were completely up to you, what type of service providers would you choose to help your organization conduct clinical trials?” (Base = 100) 100% 1% 1% 6% 12% 90% 9% 3% 1% 18% 3% 6% 11% % of Respondents 80% 70% 60% 49% 50% 32% 48% Data available in full report 40% 78% 30% 23% 20% 10% 48% 36% 15% 0% Phase I Phase II Staffing companies Phase III Phase IV © Industry Standard Research Specialty service providers (Bios, DM, Patient recruitment, Labs) Small, niche CROs Mid-size, full-service CROs Large, global CROs www.isrreports.com   © 2013|   S ponsor   U se   o f   C linical   D evelopment   O utsourcing   M odels10     www.ISRreports.com ©2013 | Clinical Development Outsourcing Models 10 www.ISRreports.com ©2013 | Preview of: Clinical Development Outsourcing Models 6
    • act with confidence Sample Page Full table of contents and additional sample pages available in the full preview, free on our website: http://www.isrreports.com/product/clinical-development-outsourcing-models/ www.ISRreports.com ©2013 | Preview of: Clinical Development Outsourcing Models 7
    • act with confidence Ordering Information For pricing and ordering information, visit our website: http://www.isrreports.com/product/clinical-development-outsourcing-models/ About Industry Standard Research Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services industries.  With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise.    For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports. www.ISRreports.com ©2013 | Preview of: Clinical Development Outsourcing Models 8
    • The ISR Difference act with confidence Custom-quality syndicated market research www.ISRreports.com ISR's Reports vs. The Common Syndicated Report How confident are you? Research methods Mostly primary research; always appropriate for the topic vs. vs. One size fits all; usually publically available data Data Collection ISR's proprietary data collection tools and channels support fast, high quality data collection vs. Struggle to recruit the right targets and enough of them Respondents Sophisticated screening ensures genuine decision-makers vs. Undisclosed methodologies and respondent demographics Sample Sizes Robust sample sizes that instill confidence vs. Often insufficient industry representation that leaves you defending results Analysts Decades of experience means more insights that are immediately usable vs. vs. Junior analysts capable of reporting numbers www.ISRreports.com ©2013 | Preview of: Preview of: Clinical Pharma Industry’s HEOR Functions www.ISRreports.com ©2013 | Benchmarking the Development Outsourcing Models 9