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19

Aug 2026

Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
By
At a Glance Live Biotherapeutic Products (LBPs) are transforming therapeutic development, with clinical programs expanding across gastrointestinal disorders, metabolic disorders, immunology, oncology, and rare conditions. Unlike conventional pharmaceutical Read More >>

14

Aug 2026

Postbiotics vs. Probiotics: Regulatory and Clinical Differences
Postbiotics vs. Probiotics: Regulatory and Clinical Differences
By
Abstract Probiotics and postbiotics are both increasingly used in microbiome-focused health products, but the regulatory and clinical considerations surrounding them can differ substantially. Probiotics depend on live microorganisms, making strain [&hellip Read More >>

06

Aug 2026

Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
By
At a Glance While many commercially available probiotics have a well-documented history of safe use in healthy populations, clinical trials evaluating live biotherapeutic products (LBPs) or probiotic dietary supplements are […] Read More >>

31

Jul 2026

IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
By
Abstract Live Biotherapeutic Products (LBPs) are biological products that contain live organisms, are applicable to the prevention, treatment, or cure of a human disease or condition, and are not vaccines. […] Read More >>

15

Jul 2026

Synbiotics: Regulatory Classification and Clinical Trial Considerations
Synbiotics: Regulatory Classification and Clinical Trial Considerations
By
Abstract Synbiotics represent an increasingly sophisticated approach to microbiome-focused products by combining live microorganisms with substrates designed to support beneficial microbial activity. However, regulatory classification and evidence requirem Read More >>

15

Jul 2026

Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
By
Abstract Postbiotics are emerging as a significant new category of microbiome-focused products, offering potential advantages over traditional probiotics through improved stability, simplified manufacturing, and greater formulation flexibility. However, de Read More >>

28

Apr 2026

Prebiotic vs Probiotic Claims: Regulatory Considerations
Prebiotic vs Probiotic Claims: Regulatory Considerations
By
As the gut microbiome continues to gain attention across food, natural health products (NHPs), and dietary supplements, prebiotic and probiotic claims have become a central focus for product development and […] Read More >>

28

Apr 2026

Monitoring Safety in Probiotic Clinical Studies: Key Considerations
Monitoring Safety in Probiotic Clinical Studies: Key Considerations
By
Probiotics are widely regarded as safe in healthy populations. However, as clinical research moves toward targeted, high-potency, and therapeutic outcomes, safety monitoring must evolve. Living organisms interact dynamically with the […] Read More >>

28

Apr 2026

Designing Placebo Controls for Probiotic Trials: Key Considerations
Designing Placebo Controls for Probiotic Trials: Key Considerations
By
Placebo-controlled studies remain the gold standard for demonstrating efficacy in clinical research. However, in probiotic trials, designing an appropriate placebo is far from straightforward. Unlike conventional pharmaceuticals, probiotics are living [&he Read More >>

20

Apr 2026

AI in Clinical Trials: Current Regulatory Expectations
AI in Clinical Trials: Current Regulatory Expectations
By
What sponsors need to know today AI isn’t a future consideration in clinical research—it’s already embedded in how trials are designed, executed, and monitored. From protocol optimization and patient recruitment […] Read More >>

31

Mar 2026

Maintaining Blinding Integrity in Probiotic and Live Biotherapeutic Trials
Maintaining Blinding Integrity in Probiotic and Live Biotherapeutic Trials
By
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 >>

11

Mar 2026

When Does a Probiotic Need a Clinical Trial?
When Does a Probiotic Need a Clinical Trial?
By
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 >>

11

Mar 2026

Designing a Probiotic Clinical Trial: Key Decisions Sponsors Must Get Right
Designing a Probiotic Clinical Trial: Key Decisions Sponsors Must Get Right
By
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 >>

27

Feb 2026

Sample size calculations for probiotic trials: What sponsors get wrong
Sample size calculations for probiotic trials: What sponsors get wrong
By
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 >>

26

Feb 2026

Which endpoint should you pick for your probiotic study?
Which endpoint should you pick for your probiotic study?
By
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 >>

22

May 2025

Risk-Based Monitoring vs. 100% Source Data Verification: Choosing the Right Approach for Your Clinical Trial
Risk-Based Monitoring vs. 100% Source Data Verification: Choosing the Right Approach for Your Clinical Trial
By
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 >>

11

Apr 2025

Clinical Research Feasibility Assessments (CRFA): Laying the Groundwork for Clinical Trial Success
Clinical Research Feasibility Assessments (CRFA): Laying the Groundwork for Clinical Trial Success
By
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 >>

05

Dec 2024

The Critical Role of Biostatistics in Clinical Trials: Ensuring Scientific Rigor and Validity
The Critical Role of Biostatistics in Clinical Trials: Ensuring Scientific Rigor and Validity
By
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 >>

23

Mar 2023

What Does a Clinical Trial Cost in Canada?
What Does a Clinical Trial Cost in Canada?
By
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 >>

17

Feb 2023

Health Canada Draft Guidance Document: On the Collection and Analysis of Disaggregated Data in Clinical Trials
Health Canada Draft Guidance Document: On the Collection and Analysis of Disaggregated Data in Clinical Trials
By
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 >>

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