Streamline and Reinforce Investigator Initiated Trials
Life science companies approve and fund investigator initiated trials to meet a number of clinical objectives while building strong relationships with key opinion leaders. The ultimate goal is publication in a medical journal to advance a drug’s — and the company’s — profile and credibility. Supported by dedicated resources, effective IIT teams reach that point by navigating process delays while maintaining regulatory compliance and investigator follow-through at every stage.
Improve IIT management from start to finish using industry benchmarks and best practices. Discover how leading companies streamline processes to make the most of what IITs offer.
Use internal controls to drive compliance
Establish SOPs that boost efficiency and guarantee accurate documentation of investigator payments.
Explore real-world models of IIT management to find out what works and what doesn’t. Know who should be involved, and when, during the four critical IIT stages, and use milestone payments to your advantage.
Accelerate IIT proposal submission and approval
Simplify IIT applications to minimize errors, and use digital systems to weed out unusable proposals.
Align committee review with proposal volume to keep opportunities moving forward. Use timeline benchmarks and trends analysis to set realistic deadlines for proposal submission and approval.
Win critical resources
Delve into the key drivers of IIT budgets and spending with detailed benchmarks and trends analysis. Gain insights into leading companies’ budgeting protocols and learn executives’ best practices for securing funding.
Refine corporate strategy
Examine how life sciences companies use IITs to accomplish broader brand and company goals. Identify the top challenges facing IIT teams and learn new strategies for overcoming them.
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- Executive Summary
- Study Methodology
- Study Definitions
- Managing Investigator Initiated Trials: Key Findings and Recommendations
- Investigator Initiated Trial Management Structures and Functional Involvement
- IIT Submission Review and Systems
- IIT Submission Channels
- IIT Review and Approval
- IIT Spending and Budgets
- Setting Corporate IIT Strategy
- IIT Management, Oversight and Compliance
- CHARTS AND GRAPHICS
- Executive Summary
- Figure E.1: Success Rating - Using IITs to Achieve Key Corporate Goals
- Figure E.2: Percentage of Companies with a Dedicated Group for IIT Management
- Figure E.3: Projected IIT Spending for 2012
- Investigator Initiated Trial Management Structures and Functional Involvement
- Figure 1.1: Percentage of Companies with a Dedicated IIT Management Group
- Figure 1.2: Corporate IIT Management Structure
- Figure 1.3: Corporate IIT Management Structure by Company Size
- Figure 1.4: Number of Separate IIT Groups for Companies Using a Decentralized Approach
- Figure 1.5: Functional Head of IIT Management
- Figure 1.6: Does Functional Head of IIT Management Hold Final Approval Over IIT Submissions?
- Figure 1.7: Company A’s IIT Management Team Structure
- Figure 1.8: Company B’s Regional Filtering of IIT Proposals
- Figure 1.9: Company B’s US IIT Filtering Process
- Figure 1.10: Company B’s US IIT Filtering Process (Continued)
- Figure 1.11: Percentage of Companies with Formal Protocols in Place for Each Stage of IIT Management
- Figure 1.12: Percentage of Companies’ Departments Involved with IIT Management: Proposal Collection and
- Screening
- Figure 1.13: Percentage of Companies’ Departments Involved with IIT Management: Proposal Evaluation and
- Approval
- Figure 1.14: Percentage of Companies’ Departments Involved with IIT Management: Study Oversight
- Figure 1.15: Percentage of Companies’ Departments Involved with IIT Management: Study Conclusion/Use of
- Data Findings
- Figure 1.16: Number of FTEs Dedicated to IIT Management in the US
- Figure 1.17: Number of FTEs Dedicated to IIT Management Companywide
- IIT Submission Review and Systems
- Figure 2.1: Channels Through Which IIT Submissions Are Received, by Percentage
- IIT Submission Channels
- Figure 2.2: Percentage of Companies with Complete Electronic Submission Systems in Place
- Figure 2.3: Percentage of IIT Submissions Received During Each Quarter
- IIT Review and Approval
- Figure 2.4: Frequency of IIT Review Committee Meetings
- Figure 2.5: Total Days for IIT Submission Review, Approval and Investigator Notification
- Figure 2.6: Average Days Spent for Each Stage of IIT Submission Review: Top 25 Companies
- Figure 2.7: Average Days Spent for Each Stage of IIT Submission Review: Top 50 Companies
- Figure 2.8: Average Days Spent for Each Stage of IIT Submission Review: Top 100 Companies
- Figure 2.9: Actual IIT Submissions Received, Evaluated and Approved in 2009
- Figure 2.10: Actual IIT Submissions Received, Evaluated and Approved in 2010
- Figure 2.11: Actual IIT Submissions Received, Evaluated and Approved in 2011
- Figure 2.12: Percentage of IIT Submissions Evaluated by Year
- Figure 2.13: Percentage of IIT Submissions Approved by Year
- IIT Spending and Budgets
- Figure 3.1: Percentage of Companies with Dedicated Funding for IIT
- Figure 3.2: Percentage of Budget Dedicated to IIT at the Beginning of Each Year
- Figure 3.3: Percentage of Budget Dedicated to IIT by Function
- Figure 3.4: Investigator Initiated Trial Spending: 2009
- Figure 3.5: Investigator Initiated Trial Spending: 2010
- Figure 3.6: Investigator Initiated Trial Spending: 2011
- Figure 3.7: Percentage Change in Investigator Initiated Trial Spending: 2009-2010
- Figure 3.8: Percentage Change in Investigator Initiated Trial Spending: 2010-2011
- Figure 3.9: Percentage Change in Investigator Initiated Trial Spending: 2009-2011
- Figure 3.10: Projected IIT Spending for 2012
- Figure 3.11: Projected Change in Investigator Initiated Trial Spending: 2011-2012
- Figure 3.12: Projected Investigator Initiated Trial Spending: 2012
- Setting Corporate IIT Strategy
- Figure 4.1: Successful Effects of Quality IIT Management Programs
- Figure 4.2: Percentage of Approved IIT that Become Medical Publications
- Figure 4.3: Percentage of Approved IITs That Gather Comparative Effectiveness Data
- Figure 4.4: Percentage of Approved IITs in Each Stage of Clinical Development
- Figure 4.5: Size of IIT Program as a percentage of All Ongoing Clinical Trials by Year
- IIT Management, Oversight and Compliance
- Figure 4.6: Percentage of Companies Citing Areas in Need of Improvement
- Figure 4.7: Top Challenge to IIT Review and Approval Process
- Figure 4.8: Top Challenge to IIT Management and Study Tracking / Oversight
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