4 min read

Self Report Outcomes: Why the best trial results come from listening

 

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2 min read

Study Outcomes: Why Less is More

Outcome measures are among the most critical decisions in clinical trial design. After all, this is what determines whether or not your product was "successful." In the case of drugs, established disease etiology dictate what constitutes a successful...

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3 min read

Natural Health Product Claim Requirements

In the United States, herbal supplements, essential oil supplements, and nutraceuticals fall under the FDA umbrella classification of dietary supplements. Dietary supplements, according to the FDA, are products which are meant to be taken internally to...

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2 min read

Drug Development: Step by Step

Natural products created from plant-based ingredients are often capable of powerful medicinal effects in the human body. Turning these formulations into an FDA-authorized drug is actually much easier and faster (and far less expensive) than many...

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3 min read

Investigational New Drug (IND) Application

If your study involves a test drug and a medical outcome (i.e. something to prevent, diagnose, or treat disease), the FDA requires an Investigational New Drug (IND) application before your product can be studied in a clinical trial. This application...

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2 min read

5 Ways to Reduce the Cost of a Clinical Trial

Clinical trials have a reputation for being massive expenditures, with budgets easily running to the millions. While this may be the case for certain pharmaceuticals, botanically based products can be studied in human trials for a fraction of that cost. 

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4 min read

What does it take to turn a botanical into an FDA-Approved drug?

The FDA has a unique, streamlined process for medicinally active plant-based products to gain market authorization. That this process is much faster and can be completed in a fraction of the cost of traditional pharmaceuticals, but many biotech start-ups...

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