Blinding is a cornerstone of clinical trial design, but in probiotic and live biotherapeutic product (LBP) studies, it is uniquely fragile. Unlike conventional pharmaceuticals, probiotics and LBPs are living systems. […] Read More >>
Not every probiotic product requires a clinical trial. Many probiotic strains already have a body of published evidence, and regulatory frameworks for dietary supplements and foods do not always mandate […] Read More >>
Probiotic trials rarely fail for a single reason. More often, problems emerge from a series of early design decisions that were never fully aligned: the strain chosen doesn’t match the […] Read More >>
Probiotic trials are frequently underpowered—not because sponsors ignore statistics, but because they underestimate how different probiotics are from conventional nutraceuticals. Unlike single-molecule ingredients, probiotics are living systems. Their ef Read More >>
Probiotic trials don’t fail only because a strain “doesn’t work.” Many fail because the endpoint doesn’t match the claim, the population, or the biology of a living product—and the study […] Read More >>
Selecting the right monitoring approach is a critical decision for sponsors designing a clinical trial. It impacts not only patient safety and data integrity but also regulatory compliance, cost, and […] Read More >>
Before a single participant is enrolled or a protocol is submitted for ethics approval, one critical document quietly shapes the course of a clinical trial: the Clinical Research Feasibility Assessment […] Read More >>
Clinical trials are the cornerstone of medical research, providing the evidence needed to assess the safety, efficacy, and optimal use of medical interventions. From drug, food, and natural health product […] Read More >>
The cost of clinical trials is often seen as a prohibiting factor for many companies and organizations with clinical research aspirations. A quick Google search will yield varying results based […] Read More >>
On December 17, 2022, Health Canada pre-published in Canada Gazette Part I, amendments to the Food and Drug Regulations (FDR). Health Canada is recommending new provisions for new drug submissions […] Read More >>
A CRO, or Contract Research Organization, is an outsourced service provider that manages clinical trials. CROs are designed to help make research more feasible. It should then come as no […] Read More >>
You have probably heard of the terms IND and NDA being used during drug development and applications. People tend to get confused between the two terms and wonder how they […] Read More >>
Clinical research in Canada has seen a significant uptick in interest from Sponsors and Investigators since the onset of the COVID-19 pandemic. This interest is perhaps a precipitate of increasing […] Read More >>
A clinical trial protocol is a document that is designed to outline all details of a clinical trial. It is the main document referred to throughout the trial lifecycle and […] Read More >>
In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials. This proposal hopes to help improve support the introduction of novel safe and […] Read More >>
Back in the 1960s a revolutionary breakthrough in x-ray technology lead to the invention of the dual-energy x-ray absorptiometry (DXA) machine. This new technology, introduced by Dr. Richard Cameron and […] Read More >>
Clinical trials proceed with four phases to assess the safety and efficacy of an Investigational Product (IP) [1]. The sample size should be considered with extra care for each of […] Read More >>
Recruitment is a crucial part of the Clinical Study workload. Even if no clinical trial is actively searching for subjects, recruitment is an ongoing process in order to build a […] Read More >>
Put yourself in the shoes of the consumer for a minute…okay…ready? You walk into a health food store to purchase supplements that you recently learned about that you hope might […] Read More >>
TORONTO, November 14, 2019 – dicentra, a leading consulting firm and clinical research organization (CRO) serving the natural health products (NHPs), food and dietary supplement industries, has announced that Dr. […] Read More >>
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