Sapient Launches GCLP-Compliant Workflows to Expand Support for Clinical Biomarker Testing

September 22, 2026 – San Diego, CA – Sapient, a leader in multi-omics data generation for biomarker discovery and clinical insight delivery, has launched designated workflows that comply with the World Health Organization’s Good Clinical Laboratory Practice (GCLP) guidance, enabling the company to expand its services for clients requiring assays to support active clinical trials – including for primary and secondary endpoints.

GCLP is an international quality standard and framework for laboratories that analyze human-derived samples from clinical trials, requiring enhanced controls for traceability, assay precision, documentation, and data integrity to produce reliable, accurate, and auditable results. Sapient has validated the instrumentation, quality management system (QMS), and laboratory information system (LIMS) used in its GCLP-compliant workflows to these standards, enabling delivery of audit-ready data for GCLP-designated studies in line with the expectations of global regulatory authorities. This documented quality framework is backed by deep QA and regulatory expertise within the Sapient team, comprising quality, operational, and scientific leaders who bring decades of combined experience supporting regulated studies for pharma and biotech sponsors.

“GCLP governs the quality of assay data used to inform the most consequential decisions clinical trial sponsors are making about dose escalation, safety, and efficacy,” said Jessica Weant, Director of Operations at Sapient. “Our clients can trust that we follow stringent practices for studies requiring GCLP compliance, to ensure the right procedure is followed, the right method is implemented, and the right records are documented, every time – equipping them with reliable, decision-grade data to act upon. It also now gives us the ability to develop targeted assays to measure primary and secondary endpoints, meaning clients can partner with Sapient for everything from exploratory analyses to late-stage trials.”

“It was important for us to expand our validated laboratory infrastructure so that clients can translate targets and biomarkers that we’ve helped them discover into targeted, regulated assays without having to move labs,” said Jonathan Usuka, PhD, MBA, Chief Executive Officer at Sapient. “Establishing GCLP-compliant workflows also reflects our commitment to quality and the rigor with which we conduct every analysis. Many of the validated systems and processes used for our GCLP-designated analyses are shared by our research-use-only workflows, so customers benefit from robust quality frameworks no matter the phase we are partnering in.”

Sapient leverages its Thermo Stellar mass spectrometry platform for regulated assay work and can develop targeted assays under GCLP for any protein in its 12,000+ protein menu or through custom assay development.

###

About Sapient

Sapient is a leader in multi-omics data generation and insight delivery, providing bespoke services for proteomics, metabolomics, and lipidomics that enable biopharma sponsors to go beyond the genome to accelerate precision drug development.

Utilizing cutting-edge, high-throughput mass spectrometry and biocomputational frameworks, Sapient enables comprehensive biomarker-phenotype mapping across thousands of biosamples for discovery of robust protein, metabolite, and lipid biomarkers, drug targets, and clinical signatures of drug response, including for GCLP-designated studies. The company’s DynamiQ™ Insights Engine – a longitudinal molecular-clinical database collected from tens of thousands of human samples – enables rapid drug target identification, biomarker discovery and validation, and translational and clinical insights across all stages of drug development. For more information, visit sapient.bio.

Media Contact:
Carla Nieser
Head of Marketing, Sapient
carla.nieser@sapient.bio
858.290.7010