Please note that the form must be filled out completely and submitted in a single session. Partially completed forms cannot be saved for completion at a later time.
Clinical and preclinical ISR submissions are currently being accepted for all IMPs; however, please check below for specific submission details for certain IMPs. Nektar support may be available in the form of funding and/or drug supply.
To submit a study proposal through our online system, please review the following checklist for information you will need to provide for your submission. Please note that the form must be filled out completely and submitted in a single session. Partially completed forms cannot be saved for completion at a later time.
- Primary investigator information: first name, last name, email address, phone number
- Institution Information: institution name, address, city, state, postal code, country
- Study Information: study type, subtype, phase, short title, therapeutic area, disease area, planned start date, number of sites and site names, participating countries, planned trial duration, planned number of patients enrolled, local Nektar contact name (if applicable), requested resource, projected costs, primary compounds, primary indication, funding from other sources, government review
- Study details: study rationale, primary objective, primary endpoint, hypothesis, study assessments, secondary objective, data and statistical plan, preclinical/clinical data supporting study, correlative studies (i.e. translational/biomarker), target patient population, specify dose, schedule, duration, and any pre-medications, etc., estimated contract review time, IRB/IAC meeting frequency, sample size calculation and justification, secondary endpoint, planned publication information, if any.
- Unexpected Serious Adverse Reaction (SUSAR) Contacts: SUSAR contact name, SUSAR contact email, SUSAR contact country
- Related documents: Curriculum Vitae (CV), study design schematic (if available), key exclusion/inclusion criteria, references/relevant Literature, supporting documents (if applicable)
Confidential, Proprietary or Confidential Information Excluded
Please do not submit any information to Nektar that is considered confidential, proprietary or private. Submission of a concept does not imply or guarantee endorsement by Nektar. Ultimately, any support provided by Nektar is contingent on an executed research agreement.