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Products & Services Medical Affairs Clinical Trials

Best Practices in the Management of Investigator Initiated Trials in CNS Therapeutic Area: Resource Allocation and Investigator Networking

ID: 5694


Features:

3 Info Graphics

14 Data Graphics

150+ Metrics

7 Narratives


Pages/Slides: 26


Published: 2021


Delivery Format: Online PDF Document


 

License Options:


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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from “Best Practices in the Management of Investigator Initiated Trials in CNS Therapeutic Area: Resource Allocation and Investigator Networking”

STUDY OVERVIEW

As most CNS manufacturers rely on investigator-initiated trials (IITs) to increase the breadth of clinical programs, it is critical that they don't let costs leapfrog results.

Therefore, it is important that organizations appropriately manage resource allocation, payment milestones and investigator networking.

Best Practices, LLC undertook this benchmarking research to provide a detailed roadmap for improving IIT management at CNS companies, capturing critical metrics and insights on IIT management staffing, budget, investigator networking and payment milestones.

KEY TOPICS

  • IIT Funding and Budget
  • FTEs for IIT Management
  • Investigator Networking
  • Payment Milestones
  • IIT Generated Publications

KEY METRICS

  • Please specify the number of FTEs dedicated to IIT management at your company; Does each FTE manage the entire process from submission to study activation and study close out, or do they manage portion of the process?
  • Please specify the time spent (number of days) on IIT management
  • Does your company have a dedicated IIT funding?
  • What was your total budget for IIT management in the last fiscal year ($USD)? How many IITs were included in your total budget in the last fiscal year?
  • What are the methods of budget forecasting for your IIT program?
  • What functions provide financial support to IITs?
  • What percentage of your total IIT budget was allocated to each of the listed areas?
  • What are the allowable indirect cost rates (in %)?
  • Do you have an escalation process if IDC requests are higher than your allowable rates? Are there any limitations on the direct costs to which IDC is applied?
  • Does your company pay for fringe benefits on salary? If yes, then what is the allowable percentage on salary? If no, then how do you manage budgets with fringe benefits request?
  • If there are multiple investigators submitting similar proposals, does your organization allow introducing these investigators to each other in case they may be interested in collaborating?
  • What determines milestone payments for clinical IITs?
  • What is the payment milestone used for clinical and non-clinical IITs?
  • What percentage of IITs generated publications in the last year?
  • Does your company require publication (abstract or peer review manuscript) as a condition for final milestone payment?

SAMPLE KEY FINDINGS

  • Budget by Function: Medical Affairs typically funds IIT programs at CNS companies. Followed by Medical Affairs (94%), R&D (25%) is the leading function to provide financial support in a quarter of companies. In CNS area, Regulatory Affairs, Marketing and Publications usually do not support IITs financially.

METHODOLOGY

Best Practices, LLC engaged 17 leaders from 13 bio-pharmaceutical companies offering CNS products through a benchmarking survey. Nearly 90% of the benchmark partners serve at the director level or above.

Industries Profiled:
Biotech; Diagnostic; Pharmaceutical; Health Care; Consumer Products; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
Allergan; Blue Earth Diagnostics; EMD Serono; Gedeon Richter ; Guerbet; Ipsen; Jazz Pharmaceuticals; Lundbeck; Merck; Novartis; Sage Therapeutics; Sanofi; Solidfarma

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.