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Consistent safety testing across global clinical trials

Reliable, fast, and globally harmonized safety testing to keep your clinical trials on track – from study set-up through to data delivery.

Reliable safety data to support every phase of your trial

Routine and safety testing underpins every clinical trial, generating the data that keeps studies progressing, regulators informed, and patients protected.

Delivering that consistently across global, multi-site trials takes more than laboratory capacity. It requires the right balance of scientific expertise, operational infrastructure, and quality oversight to manage complexity without slowing your program down.

From first-in-human studies through post-marketing programs, we support your trial with integrated routine and safety testing built on harmonized processes, accredited laboratories, and experienced teams. By aligning testing strategy, sample handling, data delivery, and regulatory requirements, you can generate reliable results that stand up to scrutiny.

Our global laboratory network enables end-to-end execution, from protocol review and kit design through to sample collection, analysis, and electronic data transfer. Designed to scale with your study, this integrated approach delivers consistent results across regions, helping you identify risk earlier, safeguard patient well-being, and act with clarity at every stage of development.

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Why partner with us for your routine and safety testing?

Expert-led project management

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  • End-to-end scientific oversight from study start-up to completion 
  • Protocol-aligned testing strategies with clear operational guidance 
  • Single, consistent point of contact for streamlined communication and accountability 
  • Proactive risk management supported by tracking tools, risk logs, and regular touchpoints

Global execution with local precision

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  • Broad international laboratory network and extended partner coverage
  • Harmonized SOPs across all sites to ensure consistent data quality
  • Reliable turnaround times for time-sensitive samples

Regulatory-ready data delivery

Scientist presenting microplate analysis on digital display
  • 21 CFR Part 11-compliant global database gives instant access to results
  • ISO 15189, CAP/CLIA, and region-appropriate accreditations
  • ICH-GCP compliance and audit traceability from protocol review through to data delivery
  • Data formats aligned to sponsor, CRO, and regulatory requirements

Delivering consistent safety testing, from protocol to data

Support your routine and safety testing with a fully integrated approach, from initial protocol review through to electronic data delivery. By connecting study setup, sample handling, testing, and reporting within harmonized workflows, your program runs consistently – no matter where your clinical sites are located.

Routine safety testing panels

Sample management and logistics

Reporting and data management

Routine safety testing panels

Routine safety testing forms the foundation of effective patient monitoring across clinical trials, providing the data needed to assess safety and maintain study continuity at every phase.

We deliver fast, dependable results through standardized testing panels, with turnaround times of 24–48 hours depending on capability and geography, ensuring you have timely data to support clinical decisions.

Our large routine safety testing menu includes:

  • Clinical chemistry (biochemistry, HbA1c) 
  • Coagulation 
  • Endocrinology
  • Hematology 
  • Pregnancy tests
  • Protein electrophoresis
  • Serology and immunology
  • Special chemistry
  • Thyroid function
  • Urinalysis
Scientists collaborating in modern laboratory workspace

Sample management and logistics

Reliable sample management is fundamental to data quality. We design and deliver customized kit solutions, coordinate transport logistics, and manage sample receipt and processing with full traceability from collection through testing.

Our sample management services include:

  • Kit design and delivery to clinical sites
  • Sample reception, processing, and laboratory information system (LIMS) tracking
  • Regional authorized labs for specimen processing and sample stabilization

Shipment coordination to analytical laboratories for specialty testing.

Female scientist handling samples

Reporting and data management

We deliver results in formats that fit your study infrastructure. The reporting format and content are agreed at study set-up, and all data is accessible through Cerba Trova, our secure, 21 CFR Part 11-compliant online portal – with real-time updates every 30 minutes.

Our reporting capabilities include:

  • Preliminary and final reports, with flagging for high, low, and critical values
  • Standard alerts including the common toxicity criteria (CTC), division of AIDS (DAIDS), and division of microbiology and infectious diseases (DMID) grading scales
  • Electronic data transfer via secure file transfer protocol (SFTP) using health level seven (HL7), Clinical Data Interchange Standards Consortium (CDISC), and custom formats depending on your data infrastructure
Scientist leading collaborative laboratory discussion

Proven impact in routine and safety testing

240+
safety testing trials supported
Duotone_Clinical-Trial
~60%
of trials combine safety and specialty testing
Frame 923 (2)
~47,300
patients screened across safety testing trials
Duotone_Patients
~41,200
patients randomized
Duotone_Female-Patient
33
market authorizations and expansions supported
Duotone_Checklist

Supporting your study with a fully integrated sample and data workflow

Generate consistent, high-quality safety data to support informed decision-making.

From protocol review through sample collection, testing, and data delivery, each stage of our workflow is designed to maintain sample integrity, minimize variability, and ensure reliable safety data across global clinical trials.

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*depending on safety testing capability and geographical location.

Global labs for routine and safety testing

Our global laboratory network delivers routine and safety testing with harmonized standard operating procedures (SOPs), shared quality frameworks, and consistent turnaround times – wherever your clinical sites are located.

Belgium

South Africa

United States

Canada

China

Taiwan

Australia

Japan

Abstract microscope imaging view of biological sample

Technologies and platforms used in routine and safety testing

For trials combining routine safety testing with specialty assays, we provide integrated laboratory solutions using validated, state-of-the-art platforms, all under a single quality framework.

High-parameter flow cytometry 

AI-driven analytics for flow cytometry 

Next-generation sequencing (NGS) 

Spatial imaging 

Digital pathology and image analysis 

Sample collection and preservation systems 

Nucleic acid extraction and preparation kits 

In situ hybridization and cytogenetics techniques 

Immunoassays 

Cellular immune response assays 

 

Related specialized services

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Logistics

Manage global sample logistics with coordinated transport, tracking, and oversight to ensure timely delivery and maintain sample integrity throughout your study.

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Kit management

Support study execution with customized kit design, assembly, and distribution, ensuring accurate collection and consistency across all clinical sites.

Close up of pipette dispensing samples inside biosafety cabinet

Bioanalysis

Support safety assessment with bioanalytical testing, including immunogenicity and pharmacokinetics, enabling reliable evaluation of biological drug exposure and immune response.

Close up of multichannel pipette dispensing into microplate

Immunoassays

Enable sensitive biomarker and safety testing with immunoassays, supporting immune monitoring, protein quantification, and clinically relevant data generation.

Close up of automated pipetting system dispensing samples into a laboratory well plate A

Flow cytometry

Enhance safety and immune monitoring with flow cytometry, enabling detailed cellular analysis to support complex clinical trial endpoints and decision-making.

Reliable safety testing, wherever your trial runs

With the right operational and scientific support, routine and safety testing can run smoothly regardless of study complexity or global reach. Connect with our experts to discuss how we can support your next trial.

More routine and safety testing insights

Prioritizing Safety in CAR-T Therapy- Patient Monitoring with Cerba Research’s Testing Portfolio
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Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

Learn how integrated testing strategies support patient monitoring and safety assessment in CAR-T clinical trials across complex treatment pathways.

Routine and safety testing FAQ