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Safety Testing

Next to specialty and biomarker testing, standard safety testing still remains the backbone of your clinical trial operations when monitoring patients during treatment. Cerba Research offers a wide range of traditional haematology, biochemistry, serology, and urinalysis evaluations, with the ability to also tap into other technologies depending on the therapeutic area.

Global Analyses for All Safety Samples

Integrating our clinical trial activity with large medical laboratories allows us to provide global analyses of all your safety samples. Our approach for these assays is fully automated, with high throughput and excess capacity across all our locations.

We secure standardization on a global scale and correlate all instruments through regular external proficiency tests to guarantee comparable reference ranges. By harmonizing standard operating procedures (SOPs) and using uniform methods and instruments in all our global laboratories, we ensure that all results are comparable and can be combined through one global database.

Delivering Safety Testing Results

We understand the importance of delivering safety testing results on time. They not only help support patient progress within a clinical trial but also provide sites with the data they need to make decisions. All of our labs participate in the appropriate RIQAS program, underpinning their quality.

Key routine safety instruments:  

  • Sysmex 
  • Roche Cobas® 
  • Beckman Coulter 
  • DiaSorin LIAISON® 
  • Siemens ADVIA Centaur 
  • Abbott ARCHITECT™ 

Accurately monitoring the safety of your innovative therapy is a crucial step in your clinical development. 

Processing Peripheral Blood Mononuclear Cells (PBMC) And BMMC (Bone Marrow Mononuclear Cells) For Clinical Trials

The usefulness and efficiency of PBMC (peripheral blood mononuclear cells) studies should not be overlooked. The increased use of these immune cells as a promising indicator of drug efficacy in clinical trials as well as the increased convenience of working with samples versus conducting testing makes PBMCs crucial. At Cerba Research we embrace the potential of PBMC activities to maximize impact in clinical research.

To keep up with rising clinical research demand we perform various PBMC activities like isolation from whole blood samples and DNA extraction using advanced technologies and equipment.

  • PBMC isolation on a global scale
  • Harmonized SOP/QC and instrumentation
  • Utilize Density Grade Centrifugation (DCG) with CPT® tubes
  • For use in immunology,  infectious diseasehematological malignancies , vaccine development, transplant therapy, personalized medicine, cell & gene therapies and toxicology

A close-up image of a scientist picking up a vial of blood from a test tube rack

Harmonized SOPs On A Global Scale For PBMC Isolation

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Viability ≥97%

Post collection using CPTtubes, the average viability obtained is 99,3% after 4 hours and 97,9% after 24hrs, 96,8% and 85,5% respectively post-thawing (source: internal data.)

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Recovery ≥75%

After thawing the average recovery is 75% (source: internal data.)

Premium Logistics

  • Management of sample processing labs
  • PBMC personal training program and certification
  • Custom sampling kits preparation
  • Sample tracking and tracing (e.g. guaranteeing a temperature-controlled supply chain and online-sample timelines.)
  • Premium courier transportation in accordance with ADR & IATA regulations

High Quality Standards

  • All our pre-processing labs are accredited to the relevant local laboratory accreditation standards, which include: CAP, GCP, GLP, ISO 17025/15189
  • Quality control and personnel training are monitored on-site to ensure compliance with the processing procedures required by the customer

Extensive Network

  • 45 processing labs in America, Europe, Africa, Asia, and Australia
  • Ability to onboard lab partners worldwide
  • PBMC isolation in 25+ countries

Standardized SOP

  • Our standard PBMC processing protocol includes Vacutainer® CPT Mononuclear Cell Preparation Tube
  • Customized upon request
  • Short turnaround times
  • Same-day PBMC isolation

Turnaround times may vary from one country to another, reflecting possible transportation delays or excessive workloads within the lab.

RIQAS RANDOX International Quality Assessment Scheme  

RIQAS is the largest international EQA (External Quality Assessment) scheme in the world. It is used by more than 50,000 laboratories in over 139 countries worldwide, ensuring an extensive database of results for many analytical methods, directly increasing statistical validity. Currently, there are 35 programs available. All our Cerba Research partner labs participate in the appropriate RIQAS programs. The entire RIQAS program at Cerba Research is coordinated by the scientific operations team.

RIQAS company logo. The logo is grey and reads ‘RIQAS’. At the end of the word is an image of earth in dark blue and white.

Related Solutions

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Speciality Laboratory Testing & Biomarker Solutions

Benefit from our customized biomarker service to obtain innovative, flexible solutions grounded in expert science.

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Assay Development

Work with our team of dedicated scientists for assay development that meets your research, clinical, or commercial objectives.

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Data & Quality

Gain easy access to your clinical study results via our secure, online platform.

Read more about data & quality and accreditation.

 

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