Clinical Testing Laboratory - Bioscience Labs
1765 South 19th Ave Bozeman, MT    
877-858-2754

Clinical Testing Laboratory

Clinical Testing Laboratory

Our start-to-finish solution for clinical trials begins with understanding our client’s end goals for the study and aiding them in the study design. Throughout the project we remain in on-going contact with our sponsors to ensure that the project is managed with the best interest of the client in mind.

At the end of each study, our clinical study team develops a final report package that includes the test protocol, study data, applicable statistical analysis and a summary report. Each final report package is reviewed by our Quality Assurance department and senior scientific staff prior to sending it to the client.

All testing is conducted on healthy human subjects and takes place in one of two clinical trials laboratory locations. In all cases, prior to recruitment of subjects, clinical studies require the approval of the Gallatin Institutional Review Board (GIRB), a group of individuals not employed by BSLI, but with whom BSLI contracts to review study protocols withe the specific objective of ensuring subject safety. In addition to the hands-on medical services provided by two consulting physicians who are not GIRB members, the GIRB ensures that unexpected and/or untoward physical reactions of any kind experienced by subjects during the course of a clinical study, termed Adverse Events (AEs), are addressed, treated, and resolved appropriately.

Methods

Services

Methods


ASTM

These are among the most commonly used ASTM methods, please note that these are not our only capabilities. After discussing your needs with our experts, we are able to purchas...

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ASTM - E2870

Standard Test Method for Evaluating Relative Effectiveness of Antimicrobial handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling This test method cov...

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ASTM - E2752

Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products This guide is designed to demonstrate the effectiveness of an antibacteria...

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ASTM - E2011

Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand This test method is designed to evaluate...

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ASTM - E1838

Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults This test method is designed to...

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ASTM - E1882

Standard Test Method for Evaluation of Antimicrobial Formulations by the Agar patch Technique This procedure can be used to evaluate formulations containing ingredients intend...

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ASTM - E1173

Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations These procedures should be used to test topical antimicrobial-contai...

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ASTM - E1174

Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations The procedure may be used to test the effectiveness of antimicrobial ha...

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ASTM - E2613

Standard Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using Fingerpads of Adults This test method is designed to assess...

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ASTM - E1115

Standard Test Method for Evaluation of Surgical Hand Scrub Formulations The procedure in this test method should be used to evaluate the activity of the test formulation in re...

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ASTM - E2755

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults This test method is designed to...

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ASTM - E2276

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the FIngerpads of Adults This test method is designed...

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ASTM - E1327

Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions The procedure should be used to test the degerming effectiveness of ...

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ASTM - E2784

Standard Test Method for Evaluation of the Effectiveness of Handwash Formulations Using the Paper Towel (Palmar) Method of Hand Contamination This procedure has been designed ...

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ASTM - E2946

Standard test method for: Determining the Bacteria-Reducing Effectiveness and Food-Handler Handwash Formulations Using Hands of Adults During testing, subjects will contaminat...

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EN

European Standard (EN) are documents that globally recognized that define best practices and requirements for test-methods. This is a list of BSLI’s most commonly practiced EN...

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EN 12791

Surgical Hand Disinfection This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical hand disinfection re...

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EN 1499

Hygienic Handwash This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handwash (water-aided) reduces...

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EN 1500

Hygienic Handrub This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub (leave-ons) reduces the...

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Services


Claim Substantiation

What does your product do better? We can provide you with scientific data to differentiate your product in today’s competitive market. Working as a team, our scientific staff ...

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Moisturization Testing

Assessing your product's ability to moisturize the skin is commonly performed at BioScience Laboratories. Using various specialized bioinstrumentation, including: TEWL, Corneo...

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Plaque Glycolysis and Regrowth Model (PGRM)

The Plaque Glycolysis and Regrowth Model (PGRM), a predictive ex vivo model, evaluates the clinical effectiveness of antimicrobial (anti-plaque and anti-gingivitis) agents on ...

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Subjective Product Claim Support

50 Subject Panels for Subjective Product Claim Support BioScience Labs can help generate data to support product claims for in-home use over time. Consumer preference claims c...

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Clinical Antimicrobial Testing

Efficacy studies are used to validate your products intended purpose, substantiate claims and/or to gain an edge on your competition. Because labeling is regulated by the FDA,...

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Agar Patch - Antimicrobial Persistence Test

Persistence, the continuance of bactericidal or bacteristatic activity for some period of time after product use, may be a very desirable attribute for topical antimicrobial p...

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Cup Scrub for Persistence

This antimicrobial effectiveness testing may be used to evaluate if a test product has persistent log10 reductions post-application. This post-application evaluation may be co...

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Food Handlers Handwash

BioScience Laboratories uses the approved ASTM E2946-13 method as well as other methods to conduct these studies. Subjects contaminate hands with E. coli incorporated into a m...

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Healthcare Personnel Handwash & Handrub

BioScience Laboratories has been closely involved in the development and refinement of the Healthcare personnel handwash & Healthcare personnel handrub testing methods use...

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Injection Site Protection

Injection sites are a common source of nosocomial infections. Proper pre-treatment and prophylaxis of these sites are important to reducing healthcare costs and improving pati...

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Pre-Operative Skin Preparation

The FDA has a process in place for formal evaluation of the results of these studies. Also of note is that ASTM's Standard Method E1173, which provides a nearly identical meth...

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Surgical Scrub

Surgical scrub formulations are designed to remove both the transient microorganism population as well as a large proportion of the normal endogenous microorganism population ...

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Clinical Safety Testing

The Skin Technology Center offers a broad spectrum of clinical and in vitro safety testing services. In clinical safety testing, BSLI evaluates in-use safety of products by me...

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Cumulative Irritation Evaluations

BioScience Laboratories Skin Technology Center performs clinical evaluations for cumulative skin irritation in accordance with the FDA/CDER Guidance for Industry, Skin Irritat...

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Sensitization Testing

BioScience Laboratories performs sensitization testing by the Modified Draize test in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and Sensitization Tes...

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Custom Product Testing

BioScience Laboratories can help you formulate how best to achieve your results based on our expertise and quantitative analysis decision-making, considering cost-benefit and ...

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Maximal Usage Trial

BACKGROUND: Since the 1970s, FDA approval of a new drug requires an evaluation of the in vivo bioavailability of the drug, as part of the drug’s safety assessment. Bioavailabi...

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In-Vitro Efficacy Testing

BioScience Laboratories has twenty three years of experience in conducting clinical & in-vitro studies on antimicrobial products used in food service, healthcare, and jani...

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Wound Care

BioScience Laboratories, Inc. has worked with wound dressings for more than 20 years. We offer a way to sell your products for more bottom-line profit to you. We evaluate seve...

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Hydration Property Testing for Wound Dressings

Studies using human subjects (intact skin) to determine the effectiveness of dressings in maintaining or augmenting skin hydration over time (e.g., alginates, foams, hydrocoll...

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Wound Healing Evaluations

Evaluations of the rate of cell proliferation, measured as a function of cellular protein expression (e.g., growth factors) in a 3-D model of wound reepithelialization....

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