clinical development outsourcing models
DESCRIPTION
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.TRANSCRIPT
Fee-for-service
Preferred Provider
Sole Source
In-Sourcing
Functional Service Provider
Compound or
Program Based
Clinical Development Outsourcing Models
©2013 Industry Standard Research www.ISRreports.com
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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
Outsourcing Models Evaluated:• Fee-for-service • Preferred Provider • Functional Service Provider
• In-Sourcing• Compound or Program Based • Sole Source
Q4, 2013 Publication Date
71Pages
74Charts and Graphs
Learn how you can use this report.
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
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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
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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-mod-els/
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Introduction
www.ISRreports.com ©2013 | Russia: Clinical Development Country Profile 7
Introduction
One way to think about the Russian clinical trial and pharmaceutical environment is to think of the country as a publically traded pharmaceutical company� If you were leafing through a prospectus or an investor presentation, you would find a com-pany with strong macro fundamentals, historic growth, inconsistent performance, and some regulatory uncertainty� In short, Russia has many of the same character-istics as a mid-stage pharmaceutical company� And, if you take a portfolio theory approach to investing, you would likely want to invest some portion of your assets in Russia� Why?
↑ Macroeconomics: Russia is the world’s 10th largest economy
↑ International recognition: Joined the World Trade Organization (WTO) in 2012
↑ Positive balance sheet: Russia has ~$240B trade surplus from fossil fuel reserves
↑ Focus: Putin announced $3�9B plan aimed at having 90% of medicines to be locally produced by 2020
↑ Reimbursement structure: Medicines Insurance System (Aug 2012) is to be in place by 2020 that will include a tiered rate of reimbursement, depending on the nature of the illness, and improve access to medications
↑ 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
Sample Page: Report Introduction
When it comes to outsourcing clinical development activities, there is a myriad of models that can be employed, ranging from using only one provider for all outsourcing needs to selecting a vendor for each individual need. Certainly, each sponsor organization must decide for itself what model (or set of models) best suits its clinical development needs.
ISR has found that most companies do not limit themselves to only one or two 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 on the need. Sponsors, however, may have different reasons for using the same model. One sponsor may choose to use preferred provider model to achieve reduced costs while another might employ the model to achieve a deeper relationship with each provider.
This research 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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Sample Page
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Executive Summary: Clinical Development Outsourcing Dynamics
www.ISRreports.com ©2013 | Clinical Development Outsourcing Models 10
Preferred Service Provider Type by PhaseRespondents prefer to use small, niche CROs for their Phase I trials; mid-size, full-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 fi rst choice of CRO but the chart below shows the type of CROs that respondents would prefer to use if the choice were completely up to them.
“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)
www.isrreports.com ©2013| Sponsor Use of Clinical Development Outsourcing Models10
Preferred Service Provider Type by Phase
Respondents prefer to use small, niche CROs for their Phase I trials; mid-size, full-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 first choice of CRO but the chart below shows the type of CROs that respondents would prefer to use if the choice were completely up to them. “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)
15%
36%
78%
48% 23%
48%
18%
32% 49%
9%
1%
11%
12% 6%
3%
6%
1% 1% 3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Phase I Phase II Phase III Phase IV
% o
f R
esp
on
de
nts
Staffing companies
Specialty service providers (Bios, DM, Patient recruitment, Labs)
Small, niche CROs
Mid-size, full-service CROs
Large, global CROs
© Industry Standard Research
Respondents prefer to use small, niche CROs for their Phase I trials. Company policies or other pressures may not always permit respondents to use their first choice of CRO but the chart below shows the type of CROs that respondents would prefer to use if the choice were completely up to them.
Data available in full report
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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-mod-els/
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Ordering Information
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 un-matched 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 [email protected], or follow us on twitter @ISRreports.
About Industry Standard Research
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