Investigator and trial criteria

Terms and conditions

Rationale
The trial must address a medical or scientific question affecting the use of an Ikaria therapy and not duplicate other planned or conducted research unless justified on a scientific or medical basis.

Sponsor
For clinical trials, the applicant (investigator, cooperative group, institution, and/or network) must be qualified and capable of conducting the proposed study in compliance with FDA and GCP standards. The sponsor must comply with all the applicable legal and regulatory requirements and must not be the subject of any legal or regulatory restrictions or sanctions.

Medical appropriateness of proposed research
The proposed research must be likely to produce results that could beneficially impact medical therapy for the condition being investigated. Please note that Ikaria research focuses on the advancement of therapies for critical care conditions.

Scientific validity
The proposed study procedures must fulfill the stated objectives of the study.

Ethical considerations
Any study undertaken must be designed to meet ethical guidelines concerning human subjects in research.

Financial support
Funding requests must reasonably reflect the cost involved and should not be used to defray normal operating expenses of the sponsor-investigator or institution that are not directly related to the supported research. An executed agreement must be in place prior to Ikaria's support of any study. All support for ISTs is awarded at the sole discretion of Ikaria based on the criteria above.

To speak with Ikaria about conducting an IST, click here.