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Products & Services Medical Affairs Clinical Trials

Best Practices in the Management of Investigator Initiated Trials in CNS Therapeutic Area: Structure, Activities and Oversight

ID: 5693


Features:

7 Info Graphics

15 Data Graphics

160+ Metrics

10 Narratives


Pages/Slides: 31


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: Structure, Activities and Oversight”

STUDY OVERVIEW

The rising number of investigator initiated trial (IIT) submissions for CNS drug candidates has made IIT management a critical operational area for CNS manufacturers. Optimizing key operational aspects of IIT management – like the structure, leadership, roles, functional involvement, and review committee – can further improve its effectiveness within CNS companies.

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 team structure, leadership and functional involvement.

KEY TOPICS

  • Key Findings and Insights
  • Activities and Responsibilities
  • Governance and SOPs with IITs
  • IIT Committee

KEY METRICS

  • Do you have a dedicated IIT management department within your organization?
  • What type of IIT studies does your organization support?
  • What is the involvement of various functions during - proposal collection and initial screening of the IIT process; IIT oversight; IIT conclusion and use of data findings; IIT publication?
  • What is the level of position of the IIT operational team lead?
  • Do you have written SOPs for IIT processes?
  • Do you have an IIT committee that oversees the selection process? What functions are represented on the IIT committee?
  • How frequently does the IIT review committee meet?
  • What role do MSLs play in IIT management?
  • At which stage, does your IIT committee allow the conversion of an IIT to a collaborative study?
  • Approximately what percentage of your total number of approved IIT submissions belong to each study type?

SAMPLE KEY FINDINGS

  • Oversight:
    • Written SOPs are the norm: 94% of companies have documented SOPs for IIT processes. SOPs guide and govern the process, provide road map, and define roles and responsibilities.

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.