One of the most common questions we hear from clients early in the product lifecycle is: "How do I let my customers know our product is safe, and that it works?"
Many times, the answer to this question is clinical research.
Running a clinical trial is an incredibly challenging undertaking, especially for companies with limited experience in the area. Many small- to medium-sized dietary supplement companies fall into this category.
It takes leadership, good communication, transparency, and committed teams to execute a clinical trial in a timely manner and to a high degree of quality.
In addition, there are always risks that must be managed along the way. Understanding what risks may arise and timing of those risks is key in taking a proactive approach to managing a clinical trial. Being prepared for the unexpected provides a pathway to success.
What exactly is involved in getting a dietary supplement clinical trial off the ground? Once a contract is signed to begin a new clinical trial, there are several key milestones along the way. These include:
- Preparation of start-up documentation
- Regulatory and/or ethics approval
- Site initiation
- First subject first visits
- Last subject enrolled
- Last subject last visit
- Database lock
- Results review
- Final report preparation
The most important message we communicate to our clients is that the planning phase--which includes those milestones listed above--can prevent costly and time-consuming changes and delays after a trial begins. In other words, there's no substitute for effective planning when conducting a dietary supplement clinical trial.
If you are considering a clinical trial to verify your dietary supplement's safety and/or efficacy, contact us to discuss your best pathway to market. Our experienced clinical trials team will help you understand the process and requirements so that you can launch your product with trust and confidence.
Josh Baisley, B.Sc., is Director of Domestic Clinical Trials at Nutrasource. With nearly 15 years of experience in quality assurance, clinical, pre-clinical, and regulatory affairs for the natural health products sector, Josh has been directly involved in over 65 clinical trials accounting for more than 10% of all clinical research applications received by Health Canada. Connect with Josh on LinkedIn.