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Clinical Trials

BioScience Laboratories has over eighteen years of experience performing clinical studies testing a wide variety of products. Receive a copy of our latest white paper: How May the Requirement to Meet the Lower Bound of the 95% Confidence Interval Affect the Sample Size for a Study?

Antimicrobial Persistence Evaluations

  • Agar Patch
  • Cup-Scrub Retrieval Past-Exposure
  • Extended-Use Claims

Consumer Product Evaluations

  • Cade and Modified Cade Handwashes
  • Non-Water-Aided Hand Sanitizers
  • General-Use Antimicrobials Soaps
  • Food-Handler Handwashes

Generic Pharmaceuticals

Healthcare Evaluations

Skin Technology

Virology

Sequestering Facilities

Sequestering Facilities are available for:

  • Proof-of-Concept Studies
  • Phase I-Phase III Studies
  • Bioavailability Studies
  • Bioequivalence Studies
  • Pharmacokinetics
  • Dosing Studies

Gallatin Institutional Review Board

To protect the well-being and health of the subject volunteers, BioScience Laboratories, contracts the services of the Gallatin Institutional Review Board (GIRB), which comprises seven members – two physicians, three nurses, one member of the clergy, and a member from the general public.  The GIRB operates in accordance with guidelines specified in 21 CFR Parts 50 and 56 and is registered with the OHRP and the FDA.  Prior to recruitment of subjects, the GIRB reviews and approves study protocols for safety and ethical propriety.  The GIRB also ensures that unexpected and/or untoward physical reaction of any kind experienced by a subject during the course of a clinical study, termed and Adverse Event (AE), is addressed, treated, and resolved appropriately and in a timely way.

View the Human-Use Antieptic Drugs Draft Guidance Document released by Health Canada.

Presentations given by the Clinical Laboratory staff:

Investigation of a Surgical Hand Antiseptic Containing 70% Ethanol and a Ployquaternium Polymer Synergist: Antimicrobial Efficacy Skin Tolerance and End User Acceptance
David R. Macings, Ph.D., Marcia Snyder, BA, Carrie A Kolly, BS, Robert R McCormack, BA, and Barry T Reece, MS,MBA; GOJO Industries, Inc., Akron, OH; BioScience Laboratories, Bozeman, MT; RCTS, Inc., Irving, TX

Contact our experts with your questions about Clinical Trials

 

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