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Investigator-Initiated Trial




The Investigator-Initiated Trial Program

Investigator-Initiated Trial (IIT) typically conducted by a clinician or scientist, referred to as a Sponsor-Investigator (SI), or an academic institution, is to pursue scientific discovery and innovation during the development and post-approval period of a pharmaceutical agent.

 

Santen supports this program which can provide valuable information regarding the safety, efficacy, pharmacology, and tolerability of Santen’s products.


Research Collaboration with Santen

Santen provides grants primarily in our therapeutic areas of expertise (retinal disorders, glaucoma, and corneal disorders) and are based on the scientific merit of the proposal.

 

Therapeutic areas are Retinal Disorders, Glaucoma, Corneal Disorders

 

All requestors must provide study details, such as scientific rationale, primary objectives, secondary objectives, primary endpoints, secondary endpoints, projected study design and fair market study budget. Applicants will be provided feedback when appropriate.

 

Study proposals that are accepted and approved will begin the IIT clinical research process in adherence to all industry guidelines and regulations, including FDA and OIG requirements.

 

Evaluation Process

  • Santen’s IIT team will review and evaluate all study proposals for scientific validity
  • Qualified applicants will be notified of decisions
  • Feedback to applicants will be provided, as appropriate
  • Study proposal approval will begin the IIT clinical research process in adherence to all industry guidelines and regulations, including FDA and OIG requirements

 

Submit an Application

To apply for a research grant, please go to the Submit Application page.


If you have any questions, please email us at iit@santeninc.com
or call (415) 268-9100.

 

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