GenomeScan strengthens clinical trial capabilities with GCLP compliance targeted for Q1 2027

For many years, GenomeScan has been a trusted genomics partner for pharmaceutical and biotechnology companies, academic medical centres, and clinical researchers, supporting a wide range of clinical and translational research projects. As precision medicine advances and genomic biomarkers become increasingly important in clinical development, the need for high-quality, traceable and reliable genomic data has never been greater. To continue fulfilling our customers’ requirements, GenomeScan is pleased to announce that it is implementing Good Clinical Laboratory Practice (GCLP), with full compliance targeted for Q1 2027.

This builds upon the strong quality culture already embedded within our organisation, including our existing ISO/IEC 17025 accreditation. Implementation of GCLP will expand GenomeScan’s ability to support genomic analyses used in patient stratification, clinical endpoints, companion diagnostic development and other regulated applications within clinical studies.

What is GCLP?

Good Clinical Laboratory Practice provides a quality framework for laboratories generating data in support of clinical trials. It promotes consistent laboratory processes, robust documentation, data integrity and traceability from sample handling through analysis and reporting. For our clients, this means increased confidence in the reliability and reproducibility of results used in regulatory submissions and clinical decision-making.

For sponsors, working with a laboratory operating under a GCLP quality framework can provide important advantages for clinical development programs:

• Clinical Data Confidence
  A GCLP quality framework supports robust data integrity, traceability and documentation, helping sponsors generate high-quality laboratory data for use in clinical development and regulatory submissions.
• Streamlined Trial Operations
  Avoid redundant audits and validations. Our GCLP compliance ensures smoother workflows and faster timelines for your clinical trials.
• End-to-End Clinical Support
  From early-phase biomarker discovery to late-phase validation, GenomeScan will offer a fully compliant and integrated analytical pipeline tailored to your trial needs.

What’s next?

Implementation is currently underway, with GCLP compliance targeted for Q1 2027. Throughout this transition, GenomeScan remains committed to providing high-quality genomic services and supporting the evolving requirements of clinical development programs. Whether you’re planning a new trial or scaling an existing one, GenomeScan is ready to support your genomic study requirements.

“What excites me most about this step is the opportunity to support our partners further in their clinical development journey. By implementing GCLP, we are combining the genomics expertise GenomeScan has built over many years with the quality framework needed to support increasingly complex clinical studies.” says Stefanie Klaver-Flores, PhD, Head of Oncology Business Unit at GenomeScan.

Planning a clinical trial involving genomic analysis? Contact Stefanie Klaver-Flores, PhD to discuss your study requirements and GenomeScan’s developing GCLP capabilities.