Why Choose Guires's FRL as Your Food Product Development (FPD) Consultant and Partner?

There are several options in almost every product area in today’s market, and the difficulty is in coming up with unique items that stand out and connect with customers. Guires Food Research Lab (FRL) takes a holistic approach to creating food and beverage products. We define, demographically target, and build effective goods through a sequential process for category selection and comprehension. The client can visit the lab to learn the process. We offer unlimited rounds of revisions to ensure customer satisfaction. The final product prototype, along with the documentation process, including the video (through email), will be shipped to the client, and in case the client is not satisfied with the video, a food technology consultant will visit the place for the product demo at the client’s costs.

What are the different forms that you deliver the Food Product Formulations?

The food industry is witnessing a new form of consumption. Keeping that in mind, we can formulate the products in the form of ready-to-eat, ready-to-drink, ready-to-mix, ready-to-serve, and ready-to-cook food products. We use ingredients that offer an added value to the development and improve its indulgence and sustainability in terms of its functional ingredients, plant-based food dyes, and natural preservatives with a clean label.

What are the sectors Food Research Lab cover?

We cover a wide range of sectors such as soups, sauces and dips, chips, tortillas, dry beverage powder, plant-based products, masalas, puddings, instant mixes and many more.

How is sensory testing been carried out?

Our sensory examination leads to the precise formulation and recipe recommendations. We develop data-driven design models based on sensory research and customer insights. The fact-based design methodology used by Guires reduces risk and gives our clients market confidence while cutting development time in half. With our dedicated sensory lab facility, our team takes satisfaction in creating and optimizing successful products in the marketplace, generating a favourable return on investment, and developing brand advocates.

Nutraceutical Clinical Trials

Guiding Your Path in Nutraceutical Clinical Trials

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Nutraceutical Clinical Trials

Navigating the Dynamic Realm of Nutraceutical Clinical Trials with Guires FRL CRO

Guires FRL CRO: Create clinically proven product claims to support your skincare, cosmetic, or personal care brand, and show that your products work and are safe to use.

The ever-expanding landscape of natural products and dietary supplements underscores the pivotal role of clinical trials in substantiating safety and efficacy. At Guires FRL, we stand as your unwavering partners, supporting you every step of the way on your nutraceutical clinical trial journey. Our seasoned team of scientific experts is poised to understand your distinctive regulatory requirements and offer tailored solutions that align with regulatory guidelines.

Harnessing the Potential of Nutraceuticals and health supplements

The recent surge in herbal supplements and nutraceuticals is propelled by their natural origins and associated health benefits. Notably, the global market for these products reached a valuation of USD 10.18 billion and USD 289.8 billion in 2021. As per the United States Food and Drug Administration (US FDA), both herbal supplements and nutraceuticals fall under the category of dietary supplements. This encompassing term includes a variety of ingredients such as vitamins, minerals, herbs, amino acids, and enzymes, often packaged in the form of concentrates, metabolites, extracts, or combinations.

In contrast to pharmaceutical drugs, dietary supplements intended to impact the structure and function of the human body do not require premarket approval by the FDA, as per the Dietary Health Supplement and Health Education Act of 1994 (DSHEA). However, manufacturers of dietary supplements must adhere to Good Manufacturing Practice (GMP) guidelines, ensure accurate labeling, and guarantee safety and absence of contaminants. Similarly, the European Union (EU) regulations for supplements revolve around health benefits rather than therapeutic claims. Nonetheless, if a dietary supplement is intended for use as a drug to diagnose, cure, prevent, or treat a disease, clinical investigations in humans require an IND (Investigational New Drug) application.

Despite not being subjected to FDA approval, conducting clinical trials for herbal supplements and nutraceuticals can substantiate health claims, enhance market differentiation, and validate their use as medicinal products. Clinical studies offer manufacturers a competitive edge amidst burgeoning competition. Given the complexity of dietary supplements and potential safety concerns, clinical trials are indispensable for ensuring consumer safety. Regarded as the ‘gold standard’ in clinical research, these trials provide crucial insights into the safety and efficacy of products in human subjects.

Clinical trials for dietary supplements differ from those for pharmaceutical drugs in various aspects, including subject types, sample sizes, endpoints, identification of surrogate markers, and the informed consent process. Most dietary supplement trials involve healthy participants and require larger sample sizes to demonstrate intended effects, often of a milder magnitude compared to drugs. Unlike drugs, dietary supplements frequently comprise mixtures of constituents. Selecting appropriate biomarkers for pharmacokinetic studies in humans poses challenges and may necessitate advanced analytical techniques. Preclinical animal studies can guide human clinical trials, aiding in determining optimal dosages, administration frequencies, and suitable biomarkers for quantification.

At Guires FRL, we possess comprehensive expertise in orchestrating clinical trials for nutraceuticals, from Phase I to Phase IV, including Bioequivalence, pharmacokinetics, pharmacodynamic studies, statistical analysis and data management adhering to ICH and GCP guidelines. Guires FRL offers high quality clinical trial services to domestic and international pharmaceutical and biopharmaceutical companies. We provide clinical trials in all phases as shown below.

Phase 1: During this initial phase of clinical trials, the drug undergoes testing on a group of healthy volunteers. The primary objectives are to assess the safety, tolerance, and overall impact of the drug on human subjects. This phase is meticulously conducted with round-the-clock medical supervision to ensure the well-being and safety of the volunteers.

Phase 2: In the second phase, the drug is administered to patients to evaluate its efficacy and safety in treating specific medical conditions. Additionally, this phase aids in determining the appropriate dosage, the method of administration, and the desired treatment outcomes.

Phase 3: Phase 3 trials are conducted on a larger scale, involving diverse subjects from various demographic and socioeconomic backgrounds. The primary focus is on comparing the drug's effectiveness to existing standard treatments in the market. These trials also explore the drug's impact on different variations of the targeted disease. Upon successful completion of Phase 3, regulatory agencies may grant approval for the drug's market introduction.

Phase 4: This phase delves deeper into assessing various aspects of the drug. Researchers evaluate additional effects, closely monitor any side effects, therapeutic indications, or adverse reactions that may occur. Often referred to as pharmacovigilance or post-marketing surveillance, Phase 4 research ensures the ongoing safety and efficacy of the drug. Clinical research remains an ongoing process throughout the drug's lifecycle, with periodic monitoring to identify and address any unexpected issues or concerns once the drug is available in the market.

Development and design of study protocols

Participant selection and recruitment

Extrapolation of preclinical data to human subjects, encompassing dosages, sampling frequencies for pharmacokinetic profiles, and biomarkers

Identification of pertinent endpoints

Identification and qualification of trial sites

Management of herbal supplements and nutraceutical products, encompassing handling, storage, transportation, and availability

Site management and study monitoring, spanning study startup, interim visits, and close-out visits.

Adherence to Good Clinical Practice (GCP) and other relevant regulatory guidelines

Procurement of ethics committee approval

Provision of writing services, encompassing Investigator's Brochure, informed consent forms, and case report forms

Reporting of safety and adverse events

Implementation of a robust quality management system and standardized operating procedures (SOPs)

Database locking and data archival

Interpretation and analysis of statistical data, creation of statistical analysis reports

Need Assistance with Your Nutraceutical Clinical Trials? We are eager to extend our expertise to aid you in conducting nutraceutical clinical trials. Reach out to our experienced team today!

Connect with us through the inquiry form, and our dedicated team of clinical research professionals will promptly get in touch with you.