At Cerba Research, we’ve harnessed over 35 years of unparalleled expertise in handling logistical clinical trials. Our robust logistics infrastructure is the cornerstone of swift and secure transportation, ensuring the seamless journey of delicate virological and PBMC samples from patients to laboratories.

In the whitepaper “10 Best Practices in Clinical Trial Operations for Virology Studies.”  we dive into the world of cutting-edge strategies and expert insights in clinical trial operations for virology studies from a practical point of view.

Key Topics Covered:

🔍 ROI and Clinical Trial Operations Management: Discover how optimizing operations can drive remarkable returns on investment, enhancing the success of your virology studies.

📊 Clinical Trial Operations KPIs: Delve into the metrics that truly matter, gaining insights into monitoring and measuring success effectively.

⚖️ Capacity and Demand Differences: Learn how to navigate the dynamic balance between capacity and demand to ensure your trials stay on track.

📚 Training & Knowledge Sharing in the Supply Chain: Elevate your supply chain with strategies for fostering knowledge sharing and empowering your team.

💡 Process Optimization: Streamline your operations for maximum efficiency, minimizing delays and maximizing outcomes.

🔗 Data Management in Clinical Trials: Master the art of data handling and management, a critical component of successful virology studies.

The rapid increase in cell and gene therapies holds unprecedented potential. However, great innovations come with great responsibilities, especially when it comes to clinical trial logistics. Mistakes in this process can be more than just harmful – they can be costly for sponsors and, even more importantly, pose risks to patient.

The whitepaper ‘‘Logistics for Cell & Gene Therapy Trials: Specific Needs Demands Special Skills” takes you through the unique challenges of cell & gene therapy trials logistics. We shed light on potential issues and emphasize the crucial role of careful planning and execution.

The concept of analytical performance includes different parameters that must be considered in the context of ensuring the quality, safety, and efficacy of an IVD device before placing it on the market. One of these parameters is precision (repeatability and reproducibility) which is summarized as the agreement between different independent measurement results of a sample in a series of measurements or between different series of measurements. Our customer sought our expertise to meet predetermined accuracy requirements on 26 parameters in the areas of bacterial infectious diseases, prenatal screening, oncology, and endocrinology to obtain CE marking for this instrument.

Discover the whole story in the case study below

The current gold standard for NAFLD diagnosis is liver biopsies evaluated by experienced pathologists who assign scores for several features (fibrosis, steatosis, inflammation and ballooning). However, documented inter-pathologist variability in scoring and semi-quantitative nature of the scoring system itself highlight the need for new methods to ensure the unbiased and consistent assessment of disease.

Our colleague Maroua Tliba has presented a poster on this during EASL 2023. Discover everything here by downloading the poster.

The ability of developing high-parameter assays allows for a deeper characterization of patients’ immune subsets with limited sample availability. Spectral flow cytometry is used to assess high-parameter immune profiling in global clinical trials. To date, there are no specific guidelines for Performance Qualification (PQ) of spectral flow cytometers. Here, we describe an in-house developed workflow for performing PQ of a Cytek® Aurora instrument in a clinical laboratory.

As flow cytometry is one of the go-to methods for fast and in-depth monitoring of immune cell populations at single cell level, clinical laboratories are observing an increase in assay complexity and number of samples to process. To scale up our operations in a qualitative and efficient manner, several aspects of the laboratory design were improved and are discussed below.

Since 1992, Cerba Research/Healthcare has pioneered the art of human genetic testing, Cerba Healthcare builds the start of the art in human genetic testing by being the first laboratory in Europe to introduce Genetic testing.

Thanks to this experience, we are able to collaborate with the life science community to provide the most suitable genomic service and enhance the power of your genetic material.

Cerba Research can work with you to select the most suitable platform and assay to reach your project expectations.

Discover all our capabilities in our latest Genomics Brochure

Welcome to our immune repertoire sequencing white paper page! We provide advanced solutions to study the diversity and specificity of immune cells in your clinical trial samples, using cutting-edge sequencing technologies and bioinformatic tools.

By analyzing the RNA sequences of the immune receptors (i.e., B-cell or T-cell receptors), we can identify and quantify the different types of immune cells present in your samples, as well as their clonal relationships and antigen recognition patterns. This information can be used to investigate immune responses to diseases, vaccines, tumors, or environmental stimuli, and to develop personalized therapies and diagnostics.

Our team of experts can guide you through the entire process, from sample preparation to data analysis and interpretation, and provide you with customized reports and visualizations.

Explore the power of immune repertoire sequencing and unlock the secrets of the immune system!

What you can find in the white papers:

• The TCR and BCR sequencing workflow
• Our standard report analysis
• Cerba Research end-to-end solution sequencing service
• Features and benefits of TCR and BCR profiling
• And more intriguing features