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Risk-Based Monitoring Market Assessment (2015)

  • ID: 3775107
  • September 2015
  • Region: Global
  • 100 Pages
  • Industry Standard Research (ISR)
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The 2015 edition of Risk-based Monitoring Market Assessment captures a view of those in the market who have or who plan to adopt RBM in addition to or as an alternative to the traditional 100% Source Data Verification (SDV) monitoring model. Within this report, the reader will learn if and how the benefits of RBM have out-weighted its risks, how RBM has changed staffing models, the experience of firms that have adopted RBM, and the expectations of firms planning to adopt the approach.

What You Will Learn:

- The benefits of adopting RBM compared to the risks

- How RBM changes staffing models and operating procedures

- The overall experience of firms that have adopted RBM

- Which phases and therapeutic areas are currently or planning to use

RBM in Clinical Trials:

- The expectations of firms planning to adopt the approach

- Which companies are recognized as leaders in RBM adoption and use

- Main barriers that prevent companies from adopting risk-based monitoring

How You Can Use This Report:

- Plan for RBM adoption based on lessons learned from firms that have already adopted RBM

- Make strategic decisions based on study site and drug supply chain impact

- Plan for potential cost impact with RBM adoption

- Compare in-house vs. outsourced tools for RBM trials

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1. Introduction

2. Methodology

3. Respondent Qualifications

4. RBM Adoption Experience
- Familiarity
- Perceptions
- - Risk
- - Benefits
- - Utilization

5. RBM Implementation Experience
- Organizational Changes
- Operating Procedures
- Direct Data Capture and Visualization
- RBM Experiences and Expectations
- - Growth
- - Quantifying Cost Impact
- - Study Site and Drug Supply Chain
- - Impact
- - Resource Planning and Deployment
- - Outsourced Activities
- Lessons Learned
- - Training and Development

6. Study Data
- Profile
- - Type of Company
- - Roles and Responsibility
- - Trial Involvement
- - Involvement in RBM
- - Job Title
- - Development Responsibility
- - Office Location
- - Age
- - Tenure in Industry
- Awareness, Interest, Trial
- - Familiarity with RBM: Pre-Definition
- - Familiarity with Remote or Centralized Monitoring
- - Familiarity with RBM: Post Definition Sole Decision
- - RBM Risk from Operations Standpoint
- - RBM Risk from Regulatory Standpoint
- - Interest in RBM
- - Reasons for Using RBM
- - Reasons for Lack of Interest in RBM
- - RBM Usage Change in Past 12 Months
- - Specific RBM Task Force or Group
- - Leading Firms in RBM
- - Familiarity with Firms’ RBM Capabilities
- - Use of Vendors for RBM
- - Data Access Capabilities
- - Importance Organization Saving
- - Money with RBM
- - Outsourcing Clinical Development Activities
- - Clinical Monitoring In-house vs. Service Provider Employees
- - RBM Current Utilization
- - RBM Anticipated Utilization
- - Roles in Overall Trial Success
- - New Positions Created
- - Awareness and Use of TransCelerate
- - RBM Methodology
- - Moving Away from Traditional Data
- - Collection Methods
- - Pursuit of Non-Traditional Clinical
- - Trial Data Capture Methods
- - Integration of Technology/Data
- - Visualization Tools
- Involved In RBM Trials
- - Number of RBM Trials by Phase
- - Number of RBM Trials by Therapeutic Area
- - RBM Outsourcing
- - In-House or Outsource RBM Resourcing
- - Quantify Change in Expenses using RBM
- - Change in Expense with RBM versus Traditional Monitoring
- - Change in Monitoring Costs/Efforts with RBM
- - Source of RBM Data Analysis/Visualization Tools
- - Impact of RBM on Clinical Sites
- - Impact of RBM on Clinical Drug
- - Supply Chain
- - Use of Preferred Providers and Strategic Partners for Clinical
- - Development
- - Utilization of Preferred Providers and Strategic Partners
- - Service Provider/CRO Usage
- - Scenarios
- - Drivers When Selecting a RBM
- - Service Provider
- - RBM Improvements
- - RBM Momentum within
- - Organization
- - Reasons for RBM Gaining
- - Momentum
- - Reasons for RBM Losing
- - Momentum
- - RBM Benefits - Mean Ranking
- - Ranking RBM Benefits - Categorical
- - Reasons Not to Adopt RBM
- - Roles Involved in RBM
- - One Lesson Learned to Improve
- - RBM
- - Improving RBM Operations/
- - Execution
- - Technical/Data Improvement for
- - RBM
- - Employee Training to Use RBM
- Planning RBM Trials
- - Reasons for Not Adopting RBM
- - RBM Outsourcing
- - In-House or Outsource RBM
- - Resource Model
- - Quantify Changes in Expenses or Time with RBM
- - Change in Expense with RBM versus Traditional Monitoring
- - Source of RBM Data Analysis/Visualization Tools
- - Impact of RBM on Clinical Sites
- - Impact of RBM on Clinical Drug Supply Chain
- - Use of Preferred Providers or Strategic Partners for Clinical Development
- - Utilization of Preferred Providers and Strategic Partners
- - Service Provider/CRO Usage Scenarios
- - Drivers When Selecting a RBM Service Provider
- - RBM Improvements
- - RBM Momentum within Organization
- - Reasons for RBM Gaining Momentum
- - Reasons for RBM Losing Momentum
- - RBM Benefits - Mean Ranking
- - RBM Benefits - Categorical Ranking
- - Reasons Not to Adopt RBM
- - Roles Involved in RBM
- - One Lesson Learned to Improve RBM
- - Employee Training to Use RBM

7. About

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