How does the overall process work?
- Contact us via email or phone and let us know of your potential interest in working with us.
- Schedule a conference call to discuss your research idea (if desired, a non-disclosure agreement may be signed prior to this call). During this initial call, it is helpful to receive input from the company scientific officer about the research design and target population to be studied. The marketing direction can often times provide relevant information that allows us to understand the target market/end user. With our knowledge of the FDA requirements regarding claims substantiation, it is important that the company provide specific information regarding the claims that they would like to make regarding the ingredient/finished product.
- Agree on general cost range and timeline for entire research project.
- We draft an informal research project outline or scope of work (complete with a budget estimate) and submit this to the company for review.
- The company modifies the project outline as needed. We can discuss the changes via telephone and email. The company representatives may decide to visit the University around this time to view facilities, discuss the project in more detail and to meet the investigators.
- Once the project design is agreed upon, we submit the required paperwork to our contract officer. The contract officer will draft a contract, including the finalized scope of work and budget, and will send this to the company via email.
- Company will review and make any needed changes and submit the contract back to our contract officer for potential modification.
- The contract will be modified as needed and resubmitted to the company for approval.
- The company officer will sign and return to our contract officer. The University representative in our research office will sign the contract and the final version will be submitted to the company.
- If needed, the application for IRB or IACUC will be submitted. In some cases, these applications are submitted prior to the contract being executed.
- Once IRB or IACUC approval is obtained, the study will begin.
- Study updates are provided to the company approximately each quarter (or more or less frequently depending on the nature of testing and timeline of protocol). This is discussed up front so that both parties have the same expectations.
- When the study is completed, a final report is submitted to the company. This is typically provided in manuscript-ready format. The company will have a specified amount of time to review and assist with any edits that may be needed (usually a maximum of 45 days).
- Once agreed upon, the manuscript will typically be submitted for review to a scientific journal. In some cases, an abstract of the work may also be presented at a national or international scientific meeting. All presentations or publications are discussed with the sponsoring company prior to submission.
- The company will be acknowledged in all presentations and publications associated with the work.