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Vertex Investigator-Initiated Studies

The Science of Possibility
Vertex creates new possibilities in medicine to cure diseases and improve people's lives. We work with leading researchers, doctors, public health experts and other collaborators who share our vision for transforming the lives of people with serious diseases, their families and society.

Uncompromising Commitment to Patients and Fearless Pursuit of Excellence
Vertex is committed to support independent, investigator-initiated research designed to advance scientific and medical knowledge about cystic fibrosis. Results of such studies may lead to a better understanding of our therapies, improve patient care, and create new ideas for further disease-related research.

Investigator-Initiated Study
An Investigator-Initiated Study (IIS) is an unsolicited research study independently developed by an investigator for which Vertex provides funding support, drug support or both. The investigator, or the institution the investigator is affiliated with, serves as the study sponsor and therefore has the responsibility for the study design, study execution, administration of the study drug (as applicable), data handling and analysis, data publication and complying with 21 CFR Part 312 and other relevant regulations, including local laws.

Types of Research Eligible for Support
Funding and/or drug support may be available for the following categories of research:

  • Clinical studies involving ORKAMBI® (lumacaftor/ivacaftor) or KALYDECO® (ivacaftor)
  • Observational studies that support research into cystic fibrosis disease states, e.g., epidemiological and outcomes studies
  • Nonclinical studies using Vertex compounds for in vitro assays or in vivo models that include funding*

*Compound only requests for nonclinical studies should be submitted directly to compoundrequests@vrtx.com

To be eligible for support, investigators must accept full responsibility for designing, conducting and monitoring their own studies.

 

Review Process

Responsibilities

Submission Process

Last updated: Monday, September 19, 2016 - 13:31