The first step is to contact us to set up a conference call. This complimentary 60-90 minute call enables our team to learn more about your project and your team's end goals. We recommend having your chief scientific officer, a key representative from your marketing team, and other important officers on this call. This enables us to learn about your target population, the marketing direction for this product, your product's end user, and the claims you would like to make regarding the finished product. A non-disclosure agreement is typically signed prior to the call.
The call concludes with a proposal for the scientific foundation required to meet your team's goals. Our expertise in clinical research, the FDA drug authorization process, and FTC claim substantiation allows us to present you with the most efficient and cost effective way to achieve your marketing goals. We will then discuss your budget and timeline for the entire project to ensure our team creates solutions that meet your needs.
Agreements & Contracts
Once a strategy is in place, our team will draft a scope of work and submit this, along with a research contract, to the company for review. The proposal can then be discussed and any requested changes can be evaluated via phone or email. If desired, a member (or members) of our research team can visit the company's headquarters to discuss the project in person.
Contract negotiations may involve billing, the size and scope of the project, deliverables, timing of project updates, and similar topics. Ethical standards, such as raw data ownership, endpoint measurements, statistical analysis, and dissemination of findings, are non-negotiable. After project negotiations are complete, a final contract will be executed.
Legal and Ethical Authorization
Immediately after executing a research contract, our team begins developing the research methodology and obtaining the legal and ethical authorizations to begin the research. This includes IRB (institutional review board) ethics approval, registration of clinical trials, and working with the FDA for IND applications. If applicable, the research protocol will be registered or submitted for publication.
Research studies will not begin until IRB approval is received. Once the necessary authorizations are all in place, the study itself begins.
The Research Process & Dissemination of Findings
While the study is underway, updates are delivered to the company according to the Deliverables portion of the research agreement. Both parties agree to update length and frequency during contract phase, ensuring that your company and our research team have the same communication expectations. Additionally, any significant updates or changes to the research process that may occur will result in immediate communication with the company as well as updates for the FDA, IRB, and any other relevant oversight agencies.
Upon completion, our team compiles a final research report for the company. This is a review-ready document that is typically longer than a published research article. The team also delivers a brief, 2-3 page overview of the findings in layperson's terms. This document is available for company-wide distribution. Where requested, our team also delivers a live stream overview of the findings via web conferencing and is available to visit your site to train your sales and marketing team to properly communicate the study's findings.
If your project results in noteworthy findings, our team may also disseminate these findings in the scientific literature, industry events, national or international scientific conferences, and other events. The company is recognized in all of the work's presentations and/or publications.
Meet Dr Hawkins
Dr. Hawkins brings 20 years of expertise in the integrative health field to her role as Executive Director of the Franklin School of Integrative Health Sciences and the leader of our clinical research team.
She holds a Bachelor’s Degree in Environmental Health from Union Institute and University, a Master’s Degree in Health Education & Promotion from the University of Alabama, a post-graduate certificate in epidemiology from the London School of Hygiene and Tropical Medicine, a PhD in Health Research from Middle Tennessee State University, and is completing the post-doctoral Global Scholars Research Training Program at Harvard Medical School. She also holds certifications in numerous natural health fields including aromatherapy, aromatic medicine, herbalism, childbirth education, and labor support.