miRNA ANALYSIS (GLP)

  • miRNA analysis (Non - GLP)

GCP/GLP standard is a requirement of Pharmaceutical industry for samples analysis to be included in a regulatory dossier.

Both custom qPCR and pre-designed assays can be designed/optimized, qualified and validated to meet these requirements.

mirna traslational and clinical services GLP mirna traslational clinical services GLP GCP GLP standard assays qPCR laboratory genechron GCP/GLP standard requirement of Pharmaceutical industry samples analysis included regulatory dossier. Both custom qPCR pre-designed assays designed/optimized, qualified validated meet requirements. Genechron Laboratory offers qPCR services compliance with GCP/GLP (Good Clinical Practice/Good Laboratory Practice) regulations US FDA guidelines (CFR 21 Part 58, Part 210 & 211 and Part 11) well other regulatory agencies worldwide. analyses carried out laboratories have received appropriate legal authorization host clinical trials activities (according DM 19/3/98) included Italian register private laboratories (AIFA OsSC). respect, Genechron solid experience qPCR validation process with high quality CRO partners.

mirna traslational clinical services GLP mirna traslational clinical services GLP GCP GLP standard assays qPCR laboratory genechron GCP/GLP standard requirement Pharmaceutical industry samples analysis included regulatory dossier. Both custom qPCR pre-designed assays designed/optimized, qualified validated meet these requirements. Genechron Laboratory offers qPCR services compliance GCP/GLP (Good Clinical Practice/Good Laboratory Practice) regulations US FDA guidelines (CFR 21 Part 58, Part 210 & 211 Part 11) other regulatory agencies worldwide. analyses carried laboratories that have received appropriate legal authorization host clinical trials activities (according to DM 19/3/98) included Italian register private laboratories (AIFA OsSC). respect, Genechron solid experience qPCR validation process with high quality CRO partners.

mirna traslational clinical services GLP mirna traslational clinical services GLP GCP GLP standard assays qPCR laboratory genechron GCP/GLP standard requirement Pharmaceutical industry samples analysis included regulatory dossier. Both custom qPCR pre-designed assays designed/optimized, qualified validated meet requirements. Genechron Laboratory offers qPCR services compliance GCP/GLP (Good Clinical Practice/Good Laboratory Practice) regulations US FDA guidelines (CFR 21 Part 58, Part 210 & 211 and Part 11) other regulatory agencies worldwide. analyses are carried laboratories that have received appropriate legal authorization host clinical trials activities (according to DM 19/3/98) included Italian register private laboratories (AIFA OsSC). respect, Genechron solid experience qPCR validation process with high quality CRO partners.

mirna traslational clinical services GLP mirna traslational clinical services GLP GCP GLP standard assays qPCR laboratory genechron GCP/GLP standard requirement Pharmaceutical industry samples analysis included regulatory dossier. Both custom qPCR pre-designed assays designed/optimized, qualified validated meet these requirements. Genechron Laboratory offers qPCR services compliance with GCP/GLP (Good Clinical Practice/Good Laboratory Practice) regulations US FDA guidelines (CFR 21 Part 58, Part 210 & 211 and Part 11) other regulatory agencies worldwide. analyses carried laboratories received appropriate legal authorization host clinical trials activities (according to DM 19/3/98) included Italian register private laboratories (AIFA OsSC). respect, Genechron solid experience qPCR validation process with high quality CRO partners.

Characteristics of a GLP assay: High specificity based on LNA primers High linearity (R2 >0,98) Dynamic range of 7 logs High intra- and inter- assay precision (CV <0,03) A mean overall accuracy > 99,59% Characteristics of a GLP assay: High specificity based on LNA primers High linearity (R2 >0,98) Dynamic range of 7 logs High intra- and inter- assay precision (CV <0,03) A mean overall accuracy > 99,59% Characteristics of a GLP assay: High specificity based on LNA primers High linearity (R2 >0,98) Dynamic range of 7 logs High intra- and inter- assay precision (CV <0,03) A mean overall accuracy > 99,59% Characteristics of a GLP assay: High specificity based on LNA primers High linearity (R2 >0,98) Dynamic range of 7 logs High intra- and inter- assay precision (CV <0,03) A mean overall accuracy > 99,59%

 

RNA extraction

GCP/GLP standard  is a requirement of Pharmaceutical industry for samples analysis to be included in a regulatory dossier. Both custom qPCR and pre-designed assays can be designed/optimized, qualified and validated to meet these requirements. Genechron Laboratory offers qPCR services in compliance with GCP/GLP (Good Clinical Practice/Good Laboratory Practice) regulations and US FDA guidelines (CFR 21 Part 58, Part 210 & 211 and Part 11) as well as other regulatory agencies worldwide.  The analyses are carried out in laboratories that have received the appropriate legal authorization to host clinical trials activities (according to DM 19/3/98) and included in the Italian register of private laboratories (AIFA OsSC). To this respect, Genechron has a solid experience in qPCR validation process with high quality CRO partners.

qPCR
    Characteristics of a GLP assay:
  • High specificity based on LNA primers
  • High linearity (R2 >0,98)
  • Dynamic range of 7 logs
  • High intra- and inter- assay precision (CV <0,03)
  • A mean overall accuracy > 99,59%