As a full service CRO, Global Clinicals Incorporated has performed human efficacy clinical trials for national brand over-the-counter drugs, dietary supplements, homeopathics and natural products. Whether your research needs are great or small, our dedicated team of professionals can be of assistance. We offer a wide range of services that include among other things:
- CLINICAL TRIALS (claim validation, efficacy, safety, tolerability)
- PRODUCT REVIEWS (claims and ingredient research)
- Bioavailability Studies
- Bioequivalence Studies
- Clinical Trial Consulting
- Complete Project Management
- Principal Investigator
- Protocol Development and Design
- Informed Consents
- IRB Submissions
- Regulatory Guidelines
- Lab Services (blood chemistries, etc.)
- Patient Database and Recruitment
- Scientific Journal Submission and Publication
- Poster Presentations
- Research For Litigation/Legal Purposes
- Clinical Trial Reviews and Audits
- Long Term Patient Follow Up / Surveys
- Other Submission Process: IND, NDA, NDI, ANDA
- Attention To Timeline!
- Quickest Study Start Up Times – we can start your project immediately!
Global Clinicals Inc. performs clinical research on a variety of products:
Dietary Supplements are products taken by mouth that contains a dietary ingredient to supplement the diet. The dietary ingredients in these products may include the following: vitamins, minerals, herbs, or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. They can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, bars, or powders. Regardless of which form, however, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.
Nutraceuticals are natural food products consumed for health purposes. They are sold in medicinal forms, as well as functional foods, and act in a way to provide the body and mind with the essential nutrients needed for proper bodily functions. Functional foods are generally defined as foods or beverages with added ingredients that improve health by reducing or preventing the risk of disease. They are non-toxic, highly specialized and support the body in healing itself and working to prevent things from going wrong. Among the 50% of North Americans who use natural supplements, many are neutraceuticals and are intended to complement traditional health care.
A food or part of a food that allegedly provides medicinal or health benefits, including the prevention and treatment of disease. A nutraceutical may be a naturally nutrient-rich or medicinally active food, such as garlic or soybeans, or it may be a specific component of a food, such as the omega-3 fish oil that can be derived from salmon and other cold-water fish.
Homeopathics are natural remedies derived from organic and inorganic sources that have been shown to have therapeutic qualities in small doses. The remedy may be diluted and rediluted several hundred times. They are chosen which at pharmacologic or toxic doses cause symptoms that mimic those that are the subject of treatment.
The practice of homeopathy dates back to the 19th century but has only gained wide acceptance in the scientific community in the past few years. The term “homeopathy” is derived from the Greek words homeo (similar) and pathos (suffering or disease). The first basic principles of homeopathy were formulated by Samuel Hahnemann in the late 1700’s. The practice of homeopathy is based on the belief that disease symptoms can be cured by small doses of substances that produce similar symptoms in healthy people.
Homeopathics have successfully addressed the following: inflammatory conditions, autoimmune diseases, ulcers, headaches, depression, ADD, fibromyalgia, chronic ear infections, menopausal symptoms, eczema, and many more.
The Federal, Drug and Cosmetic Act recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements (Sections 201 (g)(1) and 501 (b), respectively). Until recently, homeopathic drugs have been marketed on a limited scale by a few manufacturers who have been in business for many years and have predominantly served the needs of a limited number of licensed practitioners. In conjunction with this, homeopathic drug products historically have borne little or no labeling for the consumer.
Today the homeopathic drug market has grown to become a multimillion-dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products. Those products that are offered for treatment of serious disease conditions must be dispensed under the care of a licensed practitioner. Other products, offered for use in self-limiting conditions recognizable by consumers, may be marketed OTC.
Sports Nutrition is the use of functional foods and supplements by athletes and physically active individuals. Sports nutrition can provide an effective, convenient method for the athlete to boost his or her nutrient needs during training and competition. There are only people-specific diets and the first nutritional requirement for athletes and their sports fans is a well-balanced diet that contains a wide range of foods and covers daily energy expenditure. As for the composition of this diet, health professionals recommend that it should be high in carbohydrate and low in fat. Ensuring that athletes follow these guidelines is the first step in the successful nutritional support for sports participation
For general health and fitness, and to boost athletic achievement through nutrition, three basic dietary prescriptions should be followed. First, maintain a healthy body weight by adjusting food intake and exercise. Second, eat less fat and specifically less saturated fats, such as those found in animal products and tropical oils. Third, increase total carbohydrates, especially complex carbohydrates. However, over and above these general recommendations, athletes have certain critical areas of nutrition that need to be met given the extra caloric expenditure during exercise. Sports drinks, shakes, and bars help ensure they receive enough nutrients.
Herbal Medicine is the use of herbs to treat both acute and chronic conditions. Herbs and prepared herbal compounds are aHerbal Medicine is the use of herbs to treat both acute and chronic conditions. Herbs and prepared herbal compounds are available in different forms, each of which has it’s own particular characteristics. A health food store has individual herbs as well as complex herbal formulations, including raw herbs, tinctures, extracts, capsules, tablets, lozenges, and ointments. Some common medicinal herbs are: alfalfa, aloe vera, ginseng, bupleurum, burdock, calendura, carob, chamomile, dill, echinacea, fennel, fenugreek, flax, garlic, ginger, goldenseal, licorice, ma huang (ephedra), marshmallow, papaya, parsley, peppermint, red clover, rosemary, sage, skullcap, slippery elm, thyme, yarrow, and yellowdock.vailable in different forms, each of which has it’s own particular characteristics. A health food store has individual herbs as well as complex herbal formulations, including raw herbs, tinctures, extracts, capsules, tablets, lozenges, and ointments. Some common medicinal herbs are: alfalfa, aloe vera, ginseng, bupleurum, burdock, calendura, carob, chamomile, dill, echinacea, fennel, fenugreek, flax, garlic, ginger, goldenseal, licorice, ma huang (ephedra), marshmallow, papaya, parsley, peppermint, red clover, rosemary, sage, skullcap, slippery elm, thyme, yarrow, and yellowdock.
Cosmetics are articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. This includes skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants.
Cosmeceuticals is an industry word used to refer to cosmetic products that have medicinal or drug-like benefits.
A functional food is a food given an additional function (often one related to health-promotion or disease prevention) by adding new ingredients or more of existing ingredients.
The general category of functional foods includes processed food or foods fortified with health-promoting additives, like “vitamin-enriched” products. Products considered functional generally do not include products where fortification has been done to meet government regulations and the change is not recorded on the label as a significant addition (“invisible fortification”). An example of this type of fortification would be the historic addition of iodine to table salt, or Vitamin D to milk, done to resolve public health problems such as rickets. Fermented foods with live cultures are considered functional foods with probiotic benefits.
Pharmaceuticals are medicinal drugs available by prescription or over-the-counter.
Pet Supplements/Health Products are products that supplement the diets of your pets and their health for all stages of your pets life. These products include nutritional foods, vitamins, minerals, herbs and may be found in many forms such as tablets, capsules, soft gels, gel caps, or liquids. Pet health products include itch cream, powders and gels.
We love our pets and no animals are harmed in any research performed by GCI.
- Joint Health: Pain in the Act – By Global Clinicals Inc. CEO, Chris BakerJune 12, 2017 - 4:38 pm
No matter how young or old, it’s common to experience some form of pain associated with exercise. Some pain is “good”—meaning it’s a sign the body’s being taxed to stimulate muscle growth, increase strength and/or improve endurance. But some pain is bad, and the level of pain isn’t always a full indication of the severity […]
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