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.
Applicant is responsible for appropriately reporting adverse events, serious adverse events, product complaints, and any other relevant occurrences that take place during the study in accordance with all local regulations and ICH GCP.
Next Science and applicant will comply at all times with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), including its implementing regulations.
Next Science Forms
In order for proposals to be reviewed by Next Science, at minimum, applicants must download, complete, and submit the following forms:
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:
Submit completed applications to [email protected]. Upon receipt, the proposal will be given a unique ID. Please retain this ID for your records.
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.
Confirmation email will be sent upon receipt
1-2 weeks following receipt
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.