An overview of the Investigator-Initiated Trial Management Expedite Approval Timelines and Establish Compliant Funding Practices report.

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Investigator-Initiated Trial Management
Expedite Approval Timelines and
Establish Complaint Funding Practices
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2. ABSTRACT
Evaluate and Approve IIT Proposals Faster and Better While Staying Compliant.
As the number of investigator-initiated trial (IIT) submissions increase, existing IIT management
challenges magnify. An IIT’s final outcome is out of the drug manufacturer’s hands, so it is
essential for teams to properly vet each proposal. Otherwise, companies risk putting their
products — and the resulting data — in poorly designed studies with inexperienced or unqualified
investigators. Successful teams will efficiently approve IIT proposals that demonstrate scientific
merit and align with shifting corporate objectives. Finally, IITs promote KOL engagement, but
proper documentation and FMV payments are a primary concern for teams navigating current
compliance codes.
This report serves as a solution for IIT teams that struggle with these challenges. It is a detailed
roadmap for improving IIT management at key steps, from proposal submission to follow-up with
clinical investigators. Detailed benchmarks, diagrams and profiles show IIT management team
structure, both stage-by-stage and cumulative timelines, as well as performance metrics for IIT
teams across company sizes and regions. Top executives’ insights go beyond identifying problem
areas to spotlight efficient processes and best practices for rigorous IIT evaluation.
As companies strive to accelerate IIT management processes, transparency must also be
top of mind. A surefire way to boost efficiency while decreasing many compliance issues is to
implement technology that allows investigators to submit proposals online. Internet portals have
built-in systems that document submissions and approvals and act as a gateway for investigator
communication and updates. IIT teams can also turn to third-party vendors for fair market value
(FMV) assessments to safeguard against overpaying investigators.

3. ABSTRACT
Compliance is critical for IIT funding. This report contains extensive benchmarks and case
studies to help build budgets that will adequately support investigator-initiated research. But it also
provides strategies for how teams negotiate contracts and ensure FMV-compliant itemized trial
budgets.
Industry executives working in investigator-initiated trials, investigator-sponsored trials,
investigator-initiated research, and medical affairs will get the following benefits from this report:
• Timelines for approving and beginning an IIT across 10 individual companies of various sizes
and IIT teams with US, ex-US and global responsibility. IIT volume benchmarks, including the
number of proposals received, evaluated and approved and which channels are most prevalent
for submissions.
• Ratings and insights detailing 6 key criteria for assessing IIT outcomes — and red flags to
watch for.
• Infographics and data detailing IIT management structures across company size and region.
• Metrics showing communication follow-up with investigators, including frequency of updates
and medical science liaison (MSL) support.
• Actual budget line items for IIT pass-through costs, direct costs and indirect costs.
• Full budget case studies for 12 real-world IITs; each profile includes data on total company
funding, available budget line items, therapeutic area, patient enrollment and trial duration.

4. ABSTRACT
Key Questions That This Study Answers:
• Which performance metrics should companies measure to track IIT efficiency and program
value?
• What are some best practices for companies to facilitate clinical trial agreement (CTA)
negotiations?
• What IIT management structures and protocols can teams implement to accelerate the
submission, evaluation and approval stages?
• What key criteria should teams consider when evaluating IITs? What red flags should they
watch for?
• Once the IIT is approved, what are the best strategies for following up with investigators and
ensuring that trials are progressing on schedule?
• What practices should teams employ to make sure that investigators’ itemized budgets are
FMV-compliant? How do companies skillfully manage budget revisions?
• Which metrics are useful for setting annual IIT budgets?

5. REASONS TO BUY
Evaluate IIT submissions and negotiate contracts more efficiently: Delays reduce — or can even
eliminate — IIT value, postpone or negate company research goals, expend resources and
frustrate investigators.
• Learn proven strategies, such as pre-screening proposals, for expediting IIT evaluation, and
consult six key criteria for selecting the right IITs. Performance metrics, including the number
of proposals received, evaluated and approved, are also vital in accurately assessing IIT
management efficiency.
• Examine timelines showing the number of days spent on nine IIT stages. Teams must track the
time they are spending to know which stages can be shortened. These data will allow for more
detailed planning — saving time and money down the road.
• Teams surveyed for this report also identify negotiating contracts as a top challenge.
Benchmarking data indicate that establishing clear and consistent responsibilities, such as
using legal teams to help with contracts, can significantly accelerate the process.
Establish IIT management structures that facilitate fast approval and submission tracking:
Structure plays a key role in ensuring efficient IIT management.
• Involving local and global-level personnel during IIT approval processes, for example, helps to
avoid duplication of efforts.
• Examine case study examples comparing different approaches to IIT team structures, as well
as the IIT management support coming from other internal groups.
• As teams strive to accelerate IIT decision making, having efficient IIT proposal reviews is
crucial. Creating standard operating procedures (SOPs) is one key step. Another important
aspect involves IIT review committees. Data in the report explore IIT committee structures and
which functions retain voting privileges during proposal evaluation.

6. REASONS TO BUY
Benchmark IIT spending and internal management costs to build the perfect budget: Examine
benchmarks, best practices and case studies to build a solid IIT budget.
• Key metrics include the percentage of IIT budget dedicated at the beginning of each year,
sources of IIT funding, percentage of budget spent on external spending and IIT internal
management, average funding per IIT and IIT funding compared to the number of approvals.
• Along with providing overall team budgets, surveyed IIT managers were asked to elaborate on
one recently completed study.
• Because life science companies can offer support for IITs in a variety of ways, this report
examines which line items are company-funded and which items are left to the investigators.
Benchmarks include budget line items for specific pass-through costs, direct costs and indirect
costs. The report includes 12 full-budget profiles of recently completed trials.

7. ABOUT THE PUBLISHER
Pharmaceutical research intelligence firm Cutting Edge Information, was founded in 2002 by
Jason Richardson (Chief Executive Officer) and Adam Bianchi (Chief Operating Officer). The
company is located in Durham, North Carolina, and offers customized consulting and a growing
library of targeted and insightful pharmaceutical research reports.
Cutting Edge Information delivers an innovative new approach to distributing comprehensive
pharmaceutical and biotechnology benchmarking data. CEI offers objective, comprehensive
primary and secondary research on critical industry issues as well as customized consulting
services.
Learn more about this report
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