Clinical Laboratory

Clinical 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. Also, in addition to the hands-on medical services provided by two consulting physicians who are not GIRB members, the GRIB 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

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…
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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…
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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 the release of…
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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 - 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 determine…
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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 release of…
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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 antibacterial personal cleansing…
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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-containing preparations that are intended…
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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 intended 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 to…
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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 antimicrobial…
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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 covers and is…
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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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EN 12791

 Surgical Hand Disinfection This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical hand disinfection reduces the release…
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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 the…
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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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Pre-Operative Skin Preparation

The FDA has a process in place for formal evaluation of the results of these studies. Of note, also, is that ASTM's Standard Method E1173,…
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Antimicrobial Efficacy Test - Cup Scrub Challenge

This antimicrobial effectiveness testing demonstrates that Test Product has persistent log10 reductions for antimicrobial effectiveness.  This is possible due to residual antimicrobial effects in post-exposure…
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Cumulative Irritation Evaluations

BioScience Laboratories Skin Technology Center performs the Human Repeat Insult Patch Test (RIPT) for cumulative skin irritation in accordance with the FDA/CDER Guidance for Industry, Skin Irritation and…
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Food Handlers Handwash

With a lack of an FDA defined method for demonstrating efficacy of food-handler handwash products, BioScience Laboratories has developed a method and submitted it to…
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Moisturization Testing

Assessing your products ability to mosturize the skin is commonly performed at BioScience Laboratories. Using various specialized bioinstrumentation including:TEWL, Corneometer, Mexameter, Visoscan & Skicon, as well…
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Healthcare Personnel Handwash

BioScience Laboratories has been closely involved in the development and refinement of the methods used to evaluate healthcare personnel handwash products.  Our understanding of the…
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Sensitization Testing

BioScience Laboratories performs sensitization testing by the Modified Draize test in accordance with the FDA/CDER Guidence for Industry, Skin Irritation and Sensitization Testing of Generic…
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General Use Handwash

For general-use handwash studies, BioScience Laboratories follows the ASTM Standard, E1174, which includes a method for testing of general-use handwash products. This corresponds well to…
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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 residing…
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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, hydrocolloids, hydrogels,…
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Agar Patch - Antimicrobial Persistence Test

The FDA does not have a process in place for formal evaluation of results of such studies and has no recognized official method for demonstrating persistence,…
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General Irritation Testing

The Skin Technology Center performs studies of the irritancy potential of topical antimicrobial products by means of multiple applications (15 or more) of a product…
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Disinfectant and Sanitizer Testing Services

Bioscience Labs performs these challenging antimicrobial efficacy studies.  Whether you need the AOAC Germicidal Spray Products as Disinfectants Test or the AOAC Use-Dilution Test (for disinfectants requiring dilution) we…
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Injection Site Protection

Injection sites are a common source of nosocomial infections. Proper pre-treatment and prophylaxis of these sites is important to reducing healthcare costs and improving patient well-being.…
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Wound Healing Properties of Product Materials

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