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Safety Testing

Next to specialty and biomarker testing, standard safety analyses still remain the backbone of your clinical trials 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. 

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.  

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 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 disease, hematological malignancies, vaccine development, transplant therapy, personalized medicine, and toxicology.

Harmonized SOPs on a global scale for PBMCs isolation, cryopreservation and storage, ensuring high viability and recovery.

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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 and 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.)

PBMC Capability & Expertise

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 and IATA regulations 

High Quality Standards

  • All our pre-processing labs are accredited to the relevant local laboratory accreditation standards, which include: CAP, GCP, GLP, ISO17025/15189.  
  • Quality control and personnel training is 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 on-board lab partners worldwide

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. 

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