Activities

Staff

A technical team of dedicated and experienced Chemical Engineers and Laboratory Technicians, and an array of advanced equipment are ready to respond to your Bioanalysis needs and specifications. The MEDISCIS Bioanalysis Department can also help you develop and validate your assay technique.


Core Competencies

- Development and validation of bio-analytical methods
- Validation and dosing according to FDA guidelines
- Assays from “in-vitro” and clinical biological samples
- Pre-clinical and clinical studies


Method Validation

- Selectivity and matrix effect
- Linearity
- Within- and between- assay precision and accuracy
- Extraction recovery
- Dilution
- Short and long term stability in the matrix
- Freeze-thaw cycles stability in the matrix
- Stability of extracts
- Stability of solutions
- Compliance with FDA acceptance criteria: Calibration curves and QC


Click here for more information on Quality Control and Assurance


Click here for more information on Sample Protection / Data Archiving


MEDISCIS GROUP - Clinical Research Organization - FRANCE