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Scientific Expertise & High Performance = Winning Combination for Sponsors

If you’ve been involved in outsourcing projects to bioanalytical CROs for any length of time, you’ve probably sorted the CROs you work with into two groups: the ones who are really good at cranking through samples as long as you can provide them a robust method, and the ones who can solve the complex problems … read the full article » »

Categories: News, Quality Assurance and Electronic Laboratory Notebooks, Uncategorized

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A Paper-Free Fully Regulated Bioanalytical Assay Validation of Fentanyl in Human Plasma

By: Brian J. Engel; Michael R. Pugh; Barbara J. Carel; and Ronald E. Shoup   A fully validated bioanalytical method for fentanyl in EDTA human plasma spanning 5.00 – 5000 pg/mL was generated in a completely paperless laboratory. The model presented illustrates the application and interaction of multiple electronic laboratory systems to execute and document a validation … read the full article » »

Categories: Electronic Lab Notebooks (ELN), LC-MS/MS Methods

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Automated and Validated Bioanalytical LC-MS/MS Data Analysis

By: April Pisek; Jessica White; and Michael Schneider   Bioanalytical projects require numerous types of calculations to be performed on LC-MS/MS data.• Manually transferring MS/MS data into an external spreadsheet program to perform calculations requires indepthsecondary review.• A more efficient workflow is presented here in which LC-MS/MS data is acquired directly into a LIMSsystem and automatically … read the full article » »

Categories: Electronic Lab Notebooks (ELN)

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Streamlining Bioanalytical Processes with QC in Real Time

By J. Rajarao; Brian Beato; S. Weiss; April Pisek; Laurel Branstrator; Tim Grever; and Ron Shoup   All bioanalytical (BA) LC-MS/MS labs strive to provide quality data in a timely manner. One important means of assuring adequate quality is performing quality control (QC) checks on the data and laboratory procedures. Traditionally, QC is performed after … read the full article » »

Categories: Quality Assurance and Electronic Laboratory Notebooks

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