Best Practices for Managing the Life Cycle of an Investigator-Initiated Research (IIR)

Presenters: Gurveen Saberwal, PhD

Investigator Initiated Research (IIR/IIS/IISR/IIT)

 

Investigator Initiated Research is defined as ‘unsolicited‘, independent research where the Investigator or the Institution (academic, private or governmental) serves as the ‘Sponsor’ and a pharmaceutical or medical device company provides support in the form of drug/device and/or funding. A well-designed investigator initiated study can gain insights  related to disease state and/or the clinical or scientific profile of a companies products. This may ultimately lead to improved evidence-based medicine and outcomes for patients.

 

We will discuss the process of investigator initiated research program followed across industry.  The process is initiated externally by submission of IIR application via company website followed by internal company review and decision making process. This results in the execution of IIR study contract between the company and the Institution after which the study is initiated by the Investigator.

 

Learning Objectives:

  • Describe how to Create an IIR Strategy
  • Define how to optimize submission and review process
  • Evaluate External engagement

 

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