CellCarta delivers end-to-end clinical trial support with the quality, speed, and global reach your late phase clinical trial demands.
As a trusted late phase CRO, we support pharma and biotech teams with comprehensive clinical trial support to generate data that drives decisions, meets regulatory requirements, and advances programs on schedule.
In a late phase clinical trial, where regulatory scrutiny and data volume intensify, our scientists bring deep expertise across flow cytometry, immunoassays, histopathology, genomics, and mass spectrometry that operate to the rigorous quality standards your program demands.
With laboratories in North America, Europe, China, and Australia, CellCarta offers the global reach and local responsiveness required for large-scale clinical trial services across multiple regions and sites.
Inconsistent lab standards, fragmented sample logistics, and regulatory variation across regions can compromise biomarker data, delay timelines, and risk submissions.
CellCarta serves as your central lab services partner throughout the full late phase clinical trial lifecycle. Our global network of integrated laboratories operates under one harmonized quality system, ensuring consistent data wherever your samples are processed.
As an experienced late phase CRO, our teams design biomarker strategies aligned with regulatory requirements from the outset and reduce the risk of protocol amendments or data gaps.
Our clinical trial support follows a structured approach designed to protect data quality at every stage from study design to final data delivery.
Study design
Biomarker strategy and protocol planning for your endpoints.
Protocol alignment
Global regulatory alignment built in from the start.
Sample logistics
Sample kitting, shipping, and processing across all sites.
Assay execution
Validated assays run in accredited central labs globally.
Data delivery
Clean, audit-ready data packages delivered on schedule.
Regulatory support
Expert guidance on submissions across FDA, EMA, and NMPA.
Our clinical trials services are underpinned by rigorous accreditation and data security standards, giving sponsors confidence in every data point from first patient to final submission.
CellCarta laboratories are accredited by the College of American Pathologists (CAP) and hold CLIA certificates of accreditation across our global facilities. These accreditations ensure that our central lab services meet the highest standards for late phase clinical trial data.
Our data systems are 21 CFR Part 11-compliant and are covered by ISO 27001 Information Security Management accreditation across all major locations, protecting your clinical data at every stage.
End-to-end sample logistics spanning custom kitting, cold-chain shipping, PBMC processing, and biorepository storage, managed through our ISO 13485-certified logistics facilities.
Case Study
CellCarta presents a High-Resolution Mass Spectrometry (HRMS) workflow to measure M-protein levels from as little as 10 µL of sample. This is a non-invasive, sensitive, and precise quantification method that can be employed for oncology research and beyond.
News
CellCarta and Sonic Healthcare USA have formed a strategic partnership to advance CDx commercialization. Biopharma sponsors gain a proven path from assay development and FDA/IVDR regulatory approval through centralized testing to commercial lab network delivery without sacrificing assay continuity or quality.
A central lab is a single, accredited laboratory partner that performs all clinical assays for a trial, replacing site-by-site testing to ensure consistency, quality, and traceability. In late phase trials, central lab support matters because data volume, regulatory scrutiny, and multi-region enrolment make reproducibility and audit-readiness non-negotiable. Harmonized standard operating procedures, common reagents and controls, and integrated data systems remove variability that could compromise submission.
CellCarta operates CAP-accredited, CLIA-certified central labs in Belgium, USA, Canada, and China.
Samples in global late phase trials are managed through integrated logistics covering site kit design and distribution, validated cold-chain and ambient shipping, PBMC isolation and cryopreservation, biorepository storage with full chain-of-custody, and harmonized processing standard operating procedures across regions.
Logistics quality systems aligned with ISO 13485 underpin reliable performance at scale. Logistics failures are a leading cause of late phase data loss and timeline slippage. CellCarta operates ISO 13485-certified logistics facilities, supporting global trial networks.
Data integrity in late phase trials depends on validated data systems aligned with 21 CFR Part 11, harmonized standard operating procedures across regional labs, information security management aligned with ISO 27001, and a documented audit trail spanning sample chain-of-custody through final data delivery.
Cross-site bridging studies, standardized reagents and controls, and routine quality monitoring confirm reproducibility. CellCarta's late phase infrastructure includes 21 CFR Part 11-compliant data systems, ISO 27001-compliant information security across major locations, and harmonized quality systems across 8 global facilities.
A late phase clinical trial laboratory should hold accreditations recognized by major regulators, typically CAP and CLIA for clinical assay reporting in the US, and equivalents such as ISO 15189 internationally. Data systems should be aligned with 21 CFR Part 11. Information security should follow ISO 27001 standards. Logistics facilities should be ISO 13485-certified. Multi-site harmonization and demonstrated cross-lab reproducibility are equally important.
CellCarta's global facilities are CAP-accredited and CLIA-certified across Belgium, USA, Canada, and China, with ISO 27001 and ISO 13485 coverage.
Biomarker and CDx strategies tighten significantly moving into late phase. Exploratory biomarkers must be qualified or formally validated for their intended use, fit-for-purpose assays must be locked to support primary or key secondary endpoints, and companion diagnostic candidates must complete analytical and clinical validation in time for regulatory submission.
Multi-region harmonization, regulatory alignment, and bridging across earlier-phase assay versions become critical. CellCarta supports the full lifecycle, including CDx strategy, assay development, and regulatory-grade validation.
