Investigator Sponsored Research Request

Submission Requirements

Applying investigators should have applicable training, knowledge, and proficiency in the relevant therapeutic area, as well as appropriately trained staff and facilities to conduct the research. Researchers should adhere to all applicable guidelines and regulations, which include: Good Clinical Practice (GCP); Good Documentation Practice (GDP); and as applicable, Good Laboratory Practice (GLP). Additional regulations may apply.

In addition, all applicants should supply:

  • • Completed Application
  • • Copies of CV and Medical License

It is also recommended that applicant submit a cover letter (limit to 500 word count), letter of intent, list of publications, or other
supplementary information which may aid Next Science in understanding the goals and purpose of the research.

  • • Additional Information may be requested, which may include: additional scientific information (i.e. protocol),
    anticipated publications, detailed budget, NPI #, research coordinator contact info, GCP Training Certificates etc.

In order for proposals to be reviewed by Next Science, at minimum, applicants must download, complete, and submit the following forms:

  • • ISR Application Proposal
  • • Investigator Proposal Acknowledgement and Disclosure

If you are amending a Next Science-approved proposal (such as modifying the protocol or requesting additional support) please download, complete, and submit the following form:

  • • ISR Modification and Request Form

 

Next Science Forms

Submit completed applications to [email protected]

Upon receipt, the proposal will be given a unique ID. Please retain this ID for your records.

ISR Timeline

Note: ISR Submissions may be made anytime. However, only FULL and COMPLETE proposals will be reviewed.

The pictorial below demonstrates the high-level process. Actual review times may vary depending on numerous factors.

envelope icon

Submission
Confirmation email will be sent to applicant upon receipt

search icon

Clinical Review
1-2 weeks following receipt

isr icon

ISR Committee Review
8 weeks following Clinical Review

Next Science strives to provide a response to applications within ten (10) weeks of receipt of a complete submission. Submission of a concept does not express, imply, or guarantee approval or support.

ISR Committee

The Next Science ISR Committee consists of representative(s) from regulatory, clinical, and microbiology.

Submissions may be made any time. However, review times may vary and expedited review is subject to Next Science’s discretion.

Yes, a proposal may still be submitted. However, all other support must be disclosed in the application form and requests for additional documents may be made.

No, the system is equipped to receive applications and/or documents in English only.

No, only complete applications will be reviewed.

At this time, Next Science is only accepting clinical research proposals.

Yes, you may withdraw your submission at any time by notification through the ISR email portal.

MPN-WEB-033 Rev A