As a full-service Canadian contract research organization, Source has a wealth of experience supporting our clients along the research and development pathway: from the start of a product concept, to attaining a health claim on a marketed product! Our Regulatory Affairs Team has helped countless industry clients register Natural Health Products (NHPs), foods, functional foods and beverages, cosmetic products, medical devices, pet products, and over-the-counter medications in Canada, the U.S. and abroad.
A key step in any product commercialization pathway is the assessment of evidence available to support a sponsor’s desired product health claim(s).
In some instances, evidence exists to support product health claims, which makes the regulatory application process more straightforward.
With innovative health products however, it is often strategic (and/or necessary!) to generate product-specific data by conducting an individual research study, known as a clinical trial.
In today’s competitive health products market, having product-specific research provides an advantage. Our Clinical Trials Team has helped many clients to substantiate product claims, or pursue more aggressive health claims, prior to initiating regulatory pre-market review.
The Source Team can help with every aspect of the clinical trials process, including: strategic consulting; protocol design; Health Canada (or FDA) consultations; regulatory applications (Ethics and/or Health Canada) as applicable; product analytical and/or stability testing; packaging compliance; recruitment; clinical trial operations; data management; statistical analysis; and the creation of publication-ready manuscripts.
If you are looking to determine health product dosing or timing; substantiate health claims prior to registering a commercial product; or looking for a comparator study – reach out to Team Source today to discuss!
As we move into 2021 and beyond, we are pleased to continue to expand our clinical trials program both in the Winnipeg area and across Canada.