Services → GCLP RNA-seq

Clinical trial–ready transcriptomic data

GCLP-compliant short-read total RNA sequencing for transcriptome profiling and biomarker discovery, performed in a regulated laboratory environment with full traceability and quality oversight.

Ask a question

Transcriptomics in clinical trials

RNA sequencing under GCLP

Transcriptome profiling

High-accuracy Illumina short-read sequencing for profiling host transcriptomes, supporting Context of Use (CoU) in differential gene expression and pathway-based biological interpretation for clinical studies.

Method qualification and performance metrics

Fit-for-purpose qualification under GCLP, with positive controls assessing accuracy, precision, sensitivity, reproducibility, and sequencing QC. Bioinformatics pipelines are version-controlled, locked, and validated for consistent output.

Sample handling and chain of custody

Strict SOP-governed workflows ensure quality, yield, and integrity, with full traceability through LIMS integration, barcoding, and audit trails from sample receipt to reporting.

Regulatory-supportive data management

Comprehensive documentation under our Quality Management System (QMS), following ALCOA+ principles with audit trails, raw data retention, and secure, redundant archiving to ensure long-term data integrity.

GLP and GCLP compliant laboratory

We are accredited for Good Laboratory Practice (GLP) by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) for qPCR, dPCR, and molecular biology. In addition, we are Good Clinical Laboratory Practice (GCLP) compliant to ensure the safe and reliable analysis of clinical samples.

Gene expression analysis at TATAA

Samples

Tissues
Liquid biopsies
Fresh frozen
FFPE
EDTA
PAXgene tubes

Analytes

Total RNA
mRNA
miRNA
siRNA
gRNA
ASOs

When is GCLP required for transcriptomics?

GCLP compliance becomes relevant when the transcriptomic data are generated as part of regulated clinical trials. If RNA-seq is used to support secondary or exploratory endpoints, regulatory submissions, or patient monitoring, sponsors typically require analysis in a GCLP-governed environment. For discovery-phase research or purely preclinical studies, GCLP is not mandatory; however, early alignment with regulated workflows can streamline the later translation into clinical development.

When is GCLP not enough for transcriptomics?

While GCLP governs exploratory and secondary endpoint analyses in clinical trials, it is not sufficient when transcriptomic data are required as primary endpoints or as part of pivotal safety and efficacy assessments. In such cases, full GLP compliance (for nonclinical studies) or GCP compliance (for clinical trials) may be expected, depending on the regulatory framework.

For RNA-seq specifically, achieving full GLP/GCP compliance is challenging and not common, as transcriptomics is typically positioned as an exploratory or supportive assay. A practical approach is to utilize transcriptomic data to identify specific biomarkers and then transfer these into targeted qPCR or dPCR assays. At TATAA, we develop, validate, and execute such assays under GLP, providing the regulatory-grade data required for submissions and pivotal studies.