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Products & Services Medical Affairs Clinical Trials

Best Practices in the Management of Investigator Initiated Trials in CNS Therapeutic Area: Approvals, Communication and Future Prospects

ID: 5695


Features:

7 Info Graphics

9 Data Graphics

70+ Metrics

3 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: Approvals, Communication and Future Prospects”

STUDY OVERVIEW

As the number of investigator initiated trial (IIT) submissions continues to rise for CNS drug candidates, it is important that CNS manufacturers properly vet each proposal and approve the ones that demonstrate scientific merit and align with corporate objectives.

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 submission review systems, communication, performance metrics and future prospects.

The study also identifies the top challenges and future improvements to IIT management process for CNS treatments.

KEY TOPICS

  • IIT Submission Review and Systems
  • Future Improvements
  • Challenges
  • Important Criteria for IIT Evaluation
  • Key Reasons for Rejecting IIT Proposals

KEY METRICS

  • What are the most important criteria when evaluating an IIT proposal?
  • What are the reasons for automatically rejecting an IIT proposal?
  • Do you use any tool to facilitate submission review (e.g., scorecard)? If yes, what are the components of these tools?
  • How do you review concept proposals on a rolling basis or within a submission window?
  • Please rate the effectiveness of metrics used to measure IIT performance
  • What is the preferred channel for receiving IIT updates at your company? How frequently are IIT updates received?
  • Looking forward over the next 24-36 months, what do you expect will be the trend regarding the IIT funding?
  • Does your organization invite investigators onsite to present on their study findings after their study is complete, or does your organization have an ‘IST Day’? If yes, then what are the parameters used to invite the investigators?

SAMPLE KEY FINDINGS

  • Submission Review:
    • Most IIT submissions occur in an online setting: More than 40% of companies use tools like online portals, trackers and database tools to facilitate submission review.

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.