Central IRB Market Dynamics and Benchmarking

Description

Clinical research has come a long way since the 1970s, when the National Research Act of 1974 was passed in response to ethical questions about research involving human subjects. Institutional Review Boards (IRBs) are charged with overseeing that human studies research is conducted in accordance with federal and state regulations and with their own policies and procedures. The goals of IRB review are to minimize risks to participants and maximize the quality of the research data. Nonetheless, growth in public and private spending, as well as evolving scientific opportunities have created new challenges for IRBs.

Central IRBs provide an essential and required step in clinical research and as clinical research continues to grow and utilization of central IRBs becomes more popular, ISR aims to help readers stay current on happenings within the Central IRB environment. We surveyed 111 respondents regarding their insights on topics such as Central IRB selection, outsourcing trends, use, and perceptions of Central IRBs. Furthermore, recent users of 18 Central IRBs rated how well performance compared against their expectations on 21 attributes across four categories (Organization Factors, Capabilities, Submission and Review, and Study Management).

 

Biotech, Pharmaceutical companies, and CROs

  • 200+ Central IRB encounters with 18 Central IRBs
  • Learn which Central IRBs are being most utilized by your peers
  • Learn what attributes are considered the most important when selecting a Central IRB based on recent users
  • Allow readers to narrow down which Central IRB might best fit their needs, enabling readers to make a more
    informed decision when selecting Central IRB services

Central IRBs

  • Benchmark your performance against your competition
  • Forecast what to expect in terms of outsourcing Central IRB services and the use of preferred providers
  • Understand your company’s and the competition’s position in the marketplace in terms of awareness,
    familiarity and use
  • Central IRB Selection
  • Central IRB Perceptions and Interactions
  • Central IRB Performance
  • Central IRB Service Quality Profiles
  • Study Data
  • Central IRB Drilldowns
  • Demographics

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

For additional questions about any of ISR’s reports or custom research services, please contact us at info@ISRreports.com.

Central IRB Selection

Primary Section Takeaways
Preferred Providers
Most Important Selection Criteria
Roles Involved in Selection
Outsourcing Practices
Percentage of Studies Using a Central IRB
Single Central IRB vs. Multiple Central IRBs
Central IRB vs. In-House IRB Use
Central IRB Service Model Use
Central IRB Service Model Use by Company Size

Central IRB Perceptions and Interactions

Primary Section Takeaways
Central IRB Familiarity
Central IRB Leaders – Unprompted
Central IRB Leaders – Prompted
Central IRB Use

Central IRB Performance

Primary Section Takeaways
A Note on Performance Calculations
Performance Across Central IRBs
Performance Across Central IRBs
Figure 1 – Central IRB Performance: Organization Factors
Figure 2 – Central IRB Performance: Capabilities
Figure 3 – Central IRB Performance: Submission and Review
Figure 4 – Central IRB Performance: Study Management

Central IRB Service Quality Profiles

Study Data

Central IRB Leaders, Unprompted
Central IRB Leaders, Prompted
Central IRB Familiarity
Central IRB Use
Influence on Central IRB Selection
Central IRB Uniformity Within Organization
Organization Central IRB Trends
Use of Multiple Central IRBs
Central IRB vs. In-House IRB Use
Central IRB Hiring
Central IRB Service Model Use
Use of Preferred Providers
Number of Preferred Providers
Difficulty Using Non-Preferred Provider
Frequency of Using Preferred Providers
Primary Information Sources About Central IRBs
Roles Involved in Central IRB Selection
Central IRB Contracts
Central IRB Pricing
Central IRB Selection Attributes
Lessons Learned Using a Central IRB
Verbatim Responses: Lessons Learned Using a Central IRB
Familiarity with 21st Century Cure Act
21st Century Cure Act Impact on Clinical Trial Studies
Verbatim Responses: 21st Century Cure Act Impact on Clinical Trial Studies
Industry and Technology Trends Impacting Central IRB Interaction
Verbatim Responses: Industry and Technology Trends Impacting Central IRB interaction

Central IRB Drilldowns

Advarra
Asentral Inc.
Aspire Independent Review Board (part of WCG Clinical)
Biomedical Research Alliance of New York
Copernicus Group IRB (part of WCG Clinical)
Ethical and Independent Review Services
Harrison IRB
Heartland IRB
Hummingbird IRB
IntegReview IRB
IRB Company
MidLands Independent Review Board (part of WCG Clinical)
New England Independent Review Board (part of WCG Clinical)
Pearl IRB
Quorum Review
Salus IRB
Sterling Institutional Review Board
Western Institutional Review Board Inc. (part of WCG Clinical)

Demographics

Company Type and Size
Office Location
Job Tile
Primary Responsibility
Central IRB Interaction
Company Ethical Review Process
Recency of Central IRB Use

Additional information

License

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