Data Review and Analysis

Data Review and Analysis

Analysis and troubleshooting to auditing

We help ensure your sample analysis is robust, reproducible, and regulatory compliant.

We can assure quality through data analysis oversight or on-site audits. We assure quality data is made available early on to derisk later stages of the drug development process – navigating from the beginning of the drug development process through the end. From data analysis and report writing to quality control and on-site audits, our team brings industry experience and expertise in small molecules, large molecules, oligonucleotides, biomarkers, and cell and gene therapy programs.

When transitioning from method validation to production mode, the shift from a controlled environment to a real-world state sometimes brings unwelcome surprises. With our expertise and meticulous management, we can help ensure smooth sailing from method validation to production.

Services offered include,
but are not limited to:

  • Quality control and management functions
  • On-site audits
  • Scientific report writing
  • Due diligence, oversight and auditing of outsourced bioanalytical programs
  • Quick and thorough auditing of data and reports available using our proprietary software, Red Thread
  • Statistical modeling to suit your data needs. Swift statistical analyses, such as cut point and sensitivity analysis and regression parameter optimization, using our flagship software, Red Thread
  • Ensure seamless transition from method development to production

In comparing duplicate-well and single-well analysis, single-well analysis yielded equivalent results as duplicate analysis in preclinical immunogenicity assessment in less variable populations

A poster publication in partnership with PPD

Contact us today and let us know what challenges you are facing.