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» Products & Services » » Medical Affairs » Clinical Trials

Building a Competitive IIT Program: Scope, Budget, and Program

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ID: 5857

Features:

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Pages/Slides: 32

Published: 2025

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from “Building a Competitive IIT Program: Scope, Budget, and Program”

STUDY OVERVIEW

Effective Investigator-Initiated Trial (IIT) management hinges on strategic funding allocation, disciplined budgeting, and efficient program oversight. Without a well-structured approach, organizations risk financial inefficiencies and missed opportunities to maximize scientific impact.

To address these challenges, Best Practices, LLC conducted a benchmarking study examining how leading biopharma companies structure and finance their IIT programs. The research delves into funding distribution models, budget optimization strategies, and cost-efficiency best practices tailored for diverse geographic and organizational needs. These insights will enable Medical Affairs teams to refine IIT investment strategies, ensuring financial sustainability while upholding scientific integrity and innovation.

The study categorizes insights by geography (US, EU, Global) and company size (Large vs. Mid/Small Pharma), enabling organizations to assess their scope and performance relative to industry standards.

KEY TOPICS

  • Defining the Scope of IIT Support and Funding Models
  • Budget Allocation Strategies for IIT Programs
  • Financial Efficiency and Cost Management in IIT Execution
  • Regional and Company Size Trends in IIT Program Execution

KEY METRICS

  • Types of IITs supported: Overall and by region
  • IIT program scope: Approved products, active studies, and annual initiations
  • IIT study duration: Initiation to close-out, with regional comparisons
  • IIT budget insights: Reported totals, per product, and per study (large vs. mid-small pharma)
  • IIT study spend: US vs. ex-US averages, minimums, and maximums
  • IIT proposal cost breakdown: Personnel, study-related, and other expenses
  • Geographic cost distribution in IIT proposals
  • IIT management FTEs and their roles
  • Time required for IIT contract processing
  • Top strategies for improving IIT review efficiency
  • Concept proposal review models: Rolling vs. submission window

SAMPLE KEY FINDINGS

  • Study Mix: Across the total benchmark class, 57% of approved studies are Interventional, 21% are Retrospective, and 9% are Preclinical on average.

METHODOLOGY

Best Practices, LLC engaged 22 Medical Affairs and IIT leaders from 21 biopharma organizations in this research through a benchmark survey. The study categorizes insights by geography (US, EU, Global) and company size (Large vs. Mid/Small Pharma), enabling organizations to assess their scope and performance relative to industry standards. To further enrich benchmarking, the research includes proprietary data on IIT program staffing, phase intervals, streamlining strategies, and submission review approaches.

Industries Profiled:
Biopharmaceutical; Pharmaceutical; Medical Device; Manufacturing; Biotech; Consumer Products; Diagnostic; Health Care; Laboratories


Companies Profiled:
Alnylam Pharmaceuticals; Arrowhead Pharmaceuticals; AstraZeneca; Baxter International; Bayer; Biotest AG; Eli Lilly and Company; Eisai; Incyte; Intellia Therapeutics; Ionis Pharmaceuticals; Jazz Pharmaceuticals; PDS Biotechnology; Pierre Fabre; Regeneron; Rigel Pharmaceuticals; Santen; Sobi; Stemline Therapeutics; Summit Therapeutics; Veloxis Pharmaceuticals

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.

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