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Investigator Sponsored Trial
Investigator Sponsored Trial Information and Submission
American Regent, Inc. is committed to supporting Investigator Sponsored Trials (IST) to address medically and scientifically sound
research for the management of Iron Deficiency Anemia, related to Injectafer® (ferric carboxymaltose injection). American Regent, Inc.
also offers opportunities for outside qualified health care professionals and scientists interested in conducting their own research
to submit a research proposal, which is subsequently reviewed by an internal multi-disciplinary committee.
An unsolicited IST proposal may be either a clinical or non-clinical study conducted without the participation of American Regent, Inc.
Evaluation of the proposal is based on the scientific merit of research, potential benefits to patients, budget based on fair market value,
and alignment to the company’s scientific areas of interest. American Regent, Inc. expects results from any externally sponsored research to
be communicated in scientific forums, including scientific poster presentations and peer-reviewed publications.
American Regent, Inc. may provide funding in the form of financial support and/or drug product for ISTs according to a written agreement,
which requires that third-party sponsors comply with applicable laws and regulations. American Regent, Inc. provides no guarantees that it
will provide support for submitted proposals.
Please click on the link below to download the INVESTIGATOR SPONSORED TRIAL (IST) REPORT template and to submit your proposed protocol
synopsis in an electronic format, following the directions provided so we may review your submission in a timely fashion.
The following minimum information must be included in the proposal:
Once American Regent, Inc. receives the completed proposal and supportive documentation, it will be reviewed by our IST committee in accordance with
our company policy. The investigator will then be contacted once the committee has completed its review.
- Principal Investigator and Institution Name
- Study type (interventional, non-interventional)
- Type of support (drug product, financial, or both)
- Detailed budget (Based on fair market value)
- Study rationale/Objective
- Study design (control, number of treatment arms, inclusion/exclusion criteria, dose administered, treatment duration, endpoints, patient population)
- Projected study milestones/timeline (study duration, final data availability, planned study start, planned enrollment per month)
- Planned sample size and statistical powering justification
If you would like to check on the status of your submission, or have any questions, please email us at: IST@americanregent.com
Investigator Sponsored Trial Form