Investigator-Initiated Trials

As part of our commitment to delivering innovative therapies to patients worldwide, Novartis believes in the need to support ethical independent clinical research conducted by qualified third-party investigators.

The value of the scientific research produced by these investigators is key to complementing Novartis-sponsored research by helping to ensure we better understand the benefit/risk profile of our therapies, as well as enabling us to explore new opportunities addressing unmet medical needs.

The proposed clinical research must offer meaningful scientific and/or clinical objectives supported by valid study designs in which the privacy rights, safety and welfare of patients is of paramount importance.

Novartis defines IITs as “studies with scientific and medical merit developed and sponsored by an independent investigator or academic sponsor. An IIT may be a clinical or non-clinical study conducted without the participation of Novartis, for which the IIT sponsor requests Novartis to provide either funding, drug product or both.”

Novartis global investigator-initiated trial guidelines (PDF 0.3 MB) 

IIT Investigator Awareness Brochure (PDF 3.4 MB)

How do I submit an IIT request?

IIT requests are submitted via the Novartis Grants, External Studies and Managed Access System or GEMS portal.

The GEMS portal is being made available on a phased basis so you may not yet have access to it.

GEMS is currently available to investigators in the following countries:

  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom
  • United States of America

If your country appears on this list, please submit your concept by clicking here.

We will update this list regularly but please confirm with your local Novartis contact that your country site has gone live before submitting an IIT request.

Guidance on using the GEMS portal is available here : Novartis GEMS portal external user guide (PDF 0.1 MB)

For IIT related questions, please contact the medical team in your Novartis local country office.

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