The Xellia Investigator Initiated Trial (IIT) program provides support for IITs that advance medical and scientific knowledge related to Xellia products. This program is open for all investigators who are interested in receiving support for conducting their own trial and have necessary qualifications and credentials to fulfill the clinical trial commitments. Xellia support may be provided in the form of drug product, comparator drug, financial resources or all mentioned.
Call for Proposals
Xellia Pharmaceuticals (Buffalo Grove, IL) is soliciting Investigator-Initiated Trial Proposals to evaluate the use of Vancomycin Injection ready-to-use, premix product (VANCO READY™) in the long-term or acute care settings prior to and following the introduction of Xellia’s VANCO READY™ formulation.
VANCO READY™ is currently available in the following presentations: 500 mg / 100 mL, 1 g /200 mL, 1.5 g / 300 mL and 2 g / 400 mL. Additionally, Xellia Pharmaceuticals recently received FDA approval and will soon expand this portfolio offering to include the following presentations: 750 mg / 150 mL, 1.25 g / 250 mL and 1.75 g / 350 mL.
Potential Topics for Research
Does the availability of a room temperature stable, ready-to-use formulation of VANCO READY™ result in:
- An impact to operational efficiencies in the pharmacy and throughout the care setting (e.g. compounding time, medication errors, pharmaceutical waste, labor demands)
- A change in first-dose time to antibiotic (the time between order and administration), particularly in sepsis care
Other research areas of interest may include interventions to improve vancomycin dosing or clinical monitoring.
Key Requirements for Those Submitting Proposals
- Demonstrated scientific and operational capabilities to conduct a study
- Ability to submit a scientifically well-designed and well-written study proposal
- Ability to deliver against agreed timelines
- Ability to fulfill all regulatory requirements
- Agreement to deliver a written report of the final study results and intention to publish in a scientific journal or present at a professional meeting or conference- medical writing support may be provided
- Agreement to required safety reporting to health authorities and Xellia
How to Submit a Proposal
- Submit a Concept Proposal and your CV via email to email@example.com.
- IIT Concept Proposal submission form can be downloaded here
- Concept Proposals will be reviewed by the Xellia IIT Review Committee based on scientific merit and alignment of corporate objectives
- Investigators submitting successful Concept Proposals will be invited to submit a Full Proposal for review and approval.
- IIT Full Proposal submission form can be downloaded here