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Roundtable Report – Infectious Disease Clinical Trials: Navigating Innovation & Rising Complexity

COVID-19 accelerated infectious disease R&D, but timelines and funding are now normalizing. Persistent operational barriers remain, and improved surveillance and communication are needed to enhance vaccine development and trial efficiency.

Our roundtable report from the World Vaccine Congress 2024 discusses the evolving landscape for infectious disease clinical trials, the operational barriers for therapeutics and vaccine development, and why improving epidemiologic surveillance and communication are critical to strengthening site and patient enrollment in clinical trials.

Panelists

Nele Langenaken

General Manager, Cerba Research

Chijioke Bennett

Senior Director, Clinical Development, Novavax

Grace Chen

Vaccine Development Consultant

Trina Racine

Director, Vaccine Development, VIDO

John Rex

Chief Medical Officer, F2G

Roxana Rustomjee

Senior Director, Clinical Development, Infectious Diseases, BioNTech

Janelle Hart

Managing Editor, Custom Content, Citeline (Moderator)

Nele Langenaken – General Manager, Cerba Research

Chijioke Bennett – Senior Director, Clinical Development, Novavax

Grace Chen – Vaccine Development Consultant

Trina Racine – Director, Vaccine Development, VIDO

John Rex – Chief Medical Officer, F2G

Roxana Rustomjee – Senior Director, Clinical Development, Infectious Diseases, BioNTech

Janelle Hart – Managing Editor, Custom Content, Citeline (Moderator)

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Brochure – Highly Sensitive HPV Detection And Genotyping

Cerba Research offers specialized HPV SPF10 PCR-detection/typing kits tailored to detect and identify HPV genotypes in vaccine and epidemiology studies. Our HPV vaccine research capabilities ensure comprehensive analysis and accurate identification of relevant genotypes. Take a look at our brochure and discover how our assay excels in analyzing HPV in formalin-fixed-paraffin embedded (FFPE) tissues, facilitating a correlation between histological findings and specific HPV genotypes.

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Article – Translating Scientific Questions Into pre-clinical Experiments

Despite global efforts, infectious diseases remain a significant threat to human health worldwide. The intricate dance between pathogens and their hosts fuels an ongoing battle, and deciphering these interactions hinges on appropriate pre-clinical models. Pre-clinical models are essential for unraveling disease mechanisms and developing novel intervention strategies.

Understanding host-pathogen interactions is pivotal for developing biomarkers and testing various interventions, including vaccines, drugs, antivirals, and antibodies. However, bridging pre-clinical findings to clinical applications remains a formidable challenge. The hurdles are manifold, ranging from the genetic variability of pathogens to variations in immune responses, necessitating specialized protocols and access to pertinent strains, equipment, and expertise.

In the article “Translating Scientific Questions Into Pre-Clinical Experiments.”  we dive into the world of infectious disease pre-clinical research, spotlighting the hurdles researchers face and how Cerba Research’s preclinical techniques and expertise spearhead breakthroughs.

Key Topics Covered:

🔍 Understanding Pre-Clinical Models

📊 Challenges In Infectious Disease Research 

💡BSL-2/ BSL-3 Pre-Clinical Studies

📚 Model Selection

💡 In Vivo and Ex Vivo Models 

🔗 Data Management in Clinical Trials

And much more! Click on the form below to download the article now!

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Fact Sheet – Virology Center of Excellence: Illuminating Insights Into Infectious Diseases

Experience the unparalleled activity of Cerba Research’s Infectious Diseases (ID) therapy sector, boasting a remarkable track record of over 600 executed trials in just the last 5 years.

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Presentation – Translating Scientific Challenges Into Scientific Challenges Into Preclinical Research Solution

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Brochure – Your Preferred Virology Contract Research Organization

Elevate your research and development with exceptional preclinical and clinical test services.

At Cerba Research we stand as your ideal virology contract research organization, redefining excellence in preclinical and clinical testing. Our commitment to innovation and precision drives us to deliver exceptional solutions for vaccines, antivirals, and diagnostics development.

Dive into our arsenal of clinical diagnostic services, including serology assays, molecular assays, and more, all designed to elevate your research.

Discover all our capabilities in our Virology & Vaccine Lab Brochure.

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White paper – Lessons Learned: 10 Best Practices In Clinical Trial Operations For Virology Studies

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.

 

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White paper – Logistics For Cell & Gene Therapy Trials: Specific Needs Demands Special Skills

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.

📚 Key Highlights in The Whitepaper:

⚙️ Complex Logistics Unraveled: Understand the intricate logistics of Cell & Gene Therapy Trials – where precision is key.

🔬 Cerba’s Real Case Study: Join us as we tackle logistics challenges in a groundbreaking viral vector-based therapy for Spinal Muscular Atrophy (SMA). Learn from real experiences.

🌐 Experts Who Understand: Discover why specialized expertise matters for successful Cell & Gene Therapy Trials logistics.

🗺️ Managing Across Locations: Learn to efficiently handle logistics across different places while ensuring therapy integrity.

📜 Navigating Regulations: Get insights into the rules that guide these therapies and shape logistics decisions.

📊 Handling Data Right: Explore strategies for accurate, secure, and compliant data management.

 

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White paper – Decoding A TCR And BCR Fingerprint – Immune Repertoire Sequencing

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

 

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Presentation – Automatization Of Immunohistochemistry Data Analysis For Protocol Validation

This presentation was given by Marie Gerus-Durand, Principal Scientist & Validation Engineer at Cerba Research Montpellier at the JMP Discovery Summit Europe.

Cerba Research is a global company providing high-quality, specialized analytical and diagnostic solutions for clinical trials. Cerba Research Montpellier develops customized immunohistochemistry protocols to detect the expression of selected targets on patients’ tissue sections.

To be used in clinical trials, these protocols must meet the regulatory agencies’ criteria to ensure that the protocol will allow consistent results on precious patients’ samples. With the diversity of parameters evaluated and the types of evaluation possible in implementing these custom protocols, automating data analysis became a need.

Thanks to various JMP® tools, we have developed an automated analysis that saves time and homogenizes protocol performance reports by including statistical and graphical data in a Dashboard. This process, submitted as JMP Add-in, has been incorporated into our user workflows, thus facilitating our procedures.

Tour our IHC Centre of Excellence in 360°

Cerba Research takes you on a 360 degree tour of their IHC Centre of Excellence lab

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