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Phase 1 Clinical Trials

For over Twenty-two years we have conducted investigative studies for both standard and customized in-vitro and clinical studies proving product safety and efficacy on a wide range of products spanning the public consumer industry, healthcare industry, pharmaceutical, food-handling industry, and the cosmetics market. ASTM, AATCC, AOAC, CLSI, and EN standard methods are performed on a regular basis in our labs to support EPA, FDA, TGA and HC registrations and label claims. Our GLP/GCP-compliant Microbiology, Virology, and Clinical Laboratories are audited by various regulatory bodies, individual auditors, and continue to meet the highest quality & standards in the industry. We are very astute in statistical design and evaluate all studies with statistical analysis. We utilized an expansive 15,000 subject database of healthy volunteers to fill and complete our studies. 

Our Sponsors receive quality safety data in a reasonable amount of time, with a reasonable fee. From start to finish, Phase 1 Repeat Insult Patch Test, Cumulative Irritation Patch Test, Phototoxicity and Photoallergy Evaluations can all be conducted in as short as a twelve week timeframe. This includes Protocol Development, IRB review, subject recruitment, study management, CRF drafting and printing, document archiving, data management, statistical analysis and ICH final reports.

Phase 1 Clinical Trials  

  • Repeat Insult Patch Test (RIPT) - A Randomized, Controlled Study to Evaluate the Sensitizing Potential of the Investigational Product Using the Repeat Insult Patch Test Design

  • Cumulative Irritation Patch Test - 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of the Investigational Product Using the Cumulative Irritant Patch Test Design

  • Bioavailability and Bioequivalence Studies

  • Phototoxicity - 4-Day, Randomized, Controlled Study to Evaluate the Photoirritation Potential of the Investigational Product, Using the Phototoxicity Patch Test Design

  • Photoallergy - Randomized, Controlled Study to Evaluate the Photoallergic Potential of the Investigational Product, Using the Photoallergic Patch Test Design

 

The Pharmaceutical and Biotechnology industry demand outsourcing that delivers value, which is why we are constantly scanning the competitive environment to assist our customers in gaining a strategic competitive advantage. Our experience has refined our processes and set our practice apart, providing unsurpassed value-added services. 

 

Contact Bioscience Laboratories, Inc.    For more information about Phase I Clinical Trials or any of our other testing capabilities, feel free to contact us at any time 

         Phase 1 Clinical Trials