Investigator-Initiated Trial Management

Expedite Approval Timelines and Establish Compliant Funding Practices

Investigator-Initiated Trial Management


Accelerate and improve investigator-initiated trial management, track IIT performance metrics, and understand how to evaluate IIT submissions.

  • Track IIT performance metrics and approval timelines to gauge efficiency and learn which stages should be expedited.
  • Navigate compliance concerns regarding budgets and documentation.
  • Benchmark IIT spending and internal management costs to build the perfect budget.
  • Description
  • Additional information


This report delves into the key factors impacting IIT management success: proposal selection, resources, performance metrics, IIT team structure and compliance — and serves as a guide to superior IIT management. Its four chapters feature IIT team structure, process timelines, budget benchmarks and case studies, and team profiles to promote efficient and rigorous IIT evaluation.

Investigator-Initiated Trial Management: Expedite Approval Timelines and Establish Compliant Funding Practices

  • Publication Date: February 2015
  • Pages: 253
  • Chapters: 4
  • Metrics: 500+
  • Charts/Graphics: 213
  • Number of Surveys/Companies: 30+

Data have been split by geography:

  • US
  • ex-US
  • Global

Data are also split by company size and type:

  • Top 25 (16 companies)
  • 9 of Top 10 companies
  • Top 50 (10 companies)
  • Small (6 companies)
  • Device (3 companies)

Data are split by therapeutic area:

  • Oncology (4)
  • Cardiology (1)
  • Immunology (1)
  • Pain (1)
  • Pediatrics (1)
  • Ophthalmology (2)
  • Surgical (1)
  • Urology (1)
Report Features

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. The report also includes profiles of eight (8) IIT teams; each profile is broken down into three sections, detailing team structure; team budgets and spending; and number of IIT proposals. Timelines show number of days spent on nine (9) IIT management stages from concept submission to first patient in study. Cumulative timelines cover 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 include the number of proposals received, evaluated and approved and which channels are most prevalent for submissions.

Reasons to Buy

Evaluate investigator-initiated trial submissions and negotiate contracts more efficiently with proven strategies, such as pre-screening proposals, and expedite investigator-initiated trial evaluation with six key criteria for selecting the right IITs. Establish investigator-initiated trial management structures that facilitate fast approval and submission tracking, and benchmark investigator-initiated trial spending and internal management costs to build the perfect budget:

Target Audience

Any executives and team leads involved in investigator-initiated or -sponsored trials, research or studies. Additionally, any parties responsible for IIT resourcing will benefit from key metrics, including the percentage of investigator-initiated trial 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.

Chapter Example

As the number of investigator-initiated trial (IIT) submissions increases, existing IIT management challenges magnify. The final outcome of an IIT is out of a pharma company’s hands, so it is essential for teams to properly vet each proposal. Otherwise, companies risk putting their products — and the resulting data — into poorly designed studies with inexperienced or unqualified investigators. To avoid problems down the road, successful teams approve IIT proposals that demonstrate scientific merit and align with shifting corporate objectives. Structure plays a key role in ensuring efficient IIT management. IIT structures that facilitate communication across global and local teams align company goals with IIT strategies and approvals. Performance metrics provide another avenue for teams to boost IIT efficiency. Teams can track the number of submissions they receive, evaluate and approve. Another key metric is the time it takes an IIT team to move a submission through the stages of IIT approval and contract negotiations. Besides providing a productivity lift, performance metrics enable IIT teams to further demonstrate their value to the company.