Investigator-Initiated Research

Advancing Knowledge through Investigator-Initiated Research

The Opportunity

Xentria is committed to supporting Investigator-Initiated research (IIR) activities that are intended to address an unmet scientific or medical need and are aligned with Xentria's research activities. The significance of this research, alongside Xentria-funded studies, is crucial for advancing the comprehension of therapies and uncovering novel avenues for exploration.

Examples of eligible IIR that Xentria may support include but are not limited to: opportunities for academic and community-based physicians conducting preclinical and clinical studies, translational research, observational studies, and other research such as disease states, diagnostics, and health economics and outcomes. IIR proposals are unsolicited and aligned with Xentria's research strategy.

The Investigator and their organization assume responsibility for the management and conduct of the research, through the direction of the study. The Investigator must possess the necessary infrastructure and expertise to effectively carry out the proposed investigation. Xentria embraces scientifically robust research proposals that either resonate with our objectives or ignite fresh perspectives on disease-related studies. All submissions must be unsolicited, and Investigators retain full independence over study design, conduct, and reporting.

Every request will undergo thorough critical evaluation, with decisions rooted in scientific merit, practicality, and alignment with our ongoing research priorities.

How to apply

Fill out and submit the form below. Our internal committee will review each submission, and Investigators can expect to receive notification if the IIR is being considered as a research activity.

Concept Summary Form

Fields marked with an asterisk (*) are required.

Requester Information
Research Proposal Information
Study Design * (choose all that apply)

Describe the study rationale and include supporting evidence to justify hypotheses. This may come from scientific gaps that exist in published literature, current unmet medical needs or emerging treatment patterns, previous or pilot data you may have generated or some combination of these.

Type of Support * (multiple choice – can choose more than one)
Product Request Category *
Additional Product Supply Requested *

Completed budget should include:

  • Direct research costs (including overhead costs) such as participant-related costs, research-related personnel costs, diagnostic fees and services, and data management.
  • Indirect research costs (not including overhead costs) such as publication costs (e.g., preparation of manuscript, travel, etc.), IRB review fees, equipment/supply expenses, and animal-related costs (if appropriate).
Terms

I understand that completing this form expresses my interest in working with Xentria and does not guarantee support for this Externally Sponsored Research.

Guidelines

  • Study will be performed in accordance with all applicable local and international laws and regulations (e.g., GxP guidelines, etc.)
  • Institution is solely responsible for ensuring the appropriate storage and accountability of any Xentria product delivered to the Institution, and to any sub-sites (if applicable).

Unsolicited requests for Investigator-Initiated Research may arise subsequent to scientific discussions or meetings with Xentria. Xentria will engage in science-based dialogues to address Investigator-expressed interests, aiming to elucidate the scientific relevance of Xentria's specific therapies or development programs. It is imperative that these interactions uphold the Investigator's autonomy in making decisions regarding patient care and must not exert any undue influence.

Safety Reporting Requirements

The Investigator is accountable for promptly and accurately monitoring and reporting safety data. Adherence necessitates reporting safety data to Xentria and pertinent regulatory bodies, as applicable. These requirements will vary depending on the nature of the research.

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