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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.

And much more! Complete the form below to download the white paper now!

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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.

 

Complete the form below to download the white papers!
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Fact Sheet – Presence And Capabilities – Running Clinical Trials In Australia Infographic

With Cerba’s network spanning five continents, team up with our experienced scientists to generate early insights and direct the course of your complex trial.

Our locations consist of cutting-edge laboratories that provide a full portfolio of specialty laboratory testing, anchored by seven centers in the Americas, Europe, Africa, and Asia-Pacific regions. With consistent, high-quality data and a road map to the patients you need, we empower you to develop personalized medicines and diagnostic solutions that will change lives worldwide.

Discover our Australia capabilities

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Artbook – The Art Of Histopathology

Discover the art of histopathology through the eyes of our most skilled scientists.

Immunohistochemistry biomarkers are key players in clinical development success. Tissue biomarkers can aid in the confirmation of diagnosis, patient selection, and/or for mechanistic evaluation.

If you would like to know more about how Cerba Research can help you, our IHC expert scientific team will consult with you on your specific needs. Flexible in our approach and delivery to provide timely and cost effective solutions to meet your clinical and commercial objectives.

Download our digital book to see the art of histopathology for yourself.

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Article – Changing The Shape Of Clinical Trials

Cerba Research is the Belgian division of the French Group Cerba Healthcare. The company facilitates clinical studies and lab tests, and supports the entire logistics chain. What are the developments in this market and what does the future bring?

Cerba Research may not be known to the general public, but the company does have reputable pharmaceutical companies as customers. Why do they join forces with Cerba Research, and which added value can the organization in Ghent offer? Pharmaceutical companies may have testing capabilities, but the entire logistics process that surrounds it is our specialty. For example, how can you distribute sample kits quickly, efficiently and without issues? That’s what we are perfectly suited to do. We gather all the materials needed to collect samples and deliver them neatly in kits. We also process and prepare all the patient data paperwork. Once all the data has been received, we order lab tests, in our own labs or through partners. The results are then made available to the client via PDF’s and our electronic portal.

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Article – How Saint-Antoine Hospital Is Boosting Patient Recruitment With Medical Laboratory Data

A staggering number of clinical trials fail to enroll enough patients. Most of the time, it’s not because the patients don’t exist; it’s finding them that can be difficult.

This is a struggle that Professor Karine Lacombe’s team at the infectious and tropical diseases department of Saint-Antoine Hospital in Paris know all too well. In addition to overseeing the department’s clinical research activities, she is also an investigator and co-investigator of several national and international cohort studies and multi-center trials in the field of HIV-viral hepatitis coinfection and Covid-19, and is a scientific manager of interventional studies in public health.

Professor Lacombe spoke to Clinical Trials Arena about the difficulties of patient recruitment and a new application the department is using to boost patient numbers. She starts by outlining her team’s previous approach to recruitment, which involved total reliance on the department’s own digital database of inpatient records.

“To find patients for a trial, we go into the database and use the inclusion criteria to ask if we have patients that respond to the eligibility criteria,” Professor Lacombe explains. “The problem with this approach is that we can only act on patients who are followed for chronic infection, whereas some of the trials we have recently started require patients who are in an ambulatory setting.”

For help finding outpatients, the hospital started contacting colleagues in the wider community who could search databases of their own. Often, however, these individuals didn’t have time to assist.

“It has been very difficult to identify the required patients,” says Professor Lacombe. “This approach has not only delayed inclusions; in some trials we have not even been able to include patients, especially for Covid-19 trials that addressed ambulatory care or prevention. That’s why we had to change.”

Download the full article to discover how Cerba Research has helped Saint-Antoine Hospital boost patient recruitment with medical laboratory data

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Article – The New Big Data Application That Is Reshaping Clinical Trials

The new big data application is reshaping clinical trials. Someone on the shopfloor spots an improvement or better way of doing things that snowballs into a business; it’s a familiar approach to innovation and entrepreneurship. Indeed, many big technology firms deliberately encourage this behaviour.

But it’s less common for a practising doctor to create a successful technology solution. But let that be the story of Adrien Ko, who hit the idea for his data-driven patient recruitment start-up while he was supervising a lab for Cerba Healthcare in France.

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Article – Matching Patients To Trials: Cerba Research’s Digital Tool For Improved Patient Recruitment

Patient recruitment has always been a challenge for clinical research, with most clinical trials failing to enrol enough participants in time, let alone the right patients. When trying to get a study initiated, enrolment challenges are more than just inconvenient; they can also be incredibly costly. With close to 100% of studies requiring timeline extensions for recruitment, it’s no surprise the global clinical trials industry spends more than $2 billion on enrolment efforts and delays each year.

Find out how Cerba Research is leveraging the biological and clinical data from patients visiting its parent company’s network of clinics.

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Article – Cerba Research Expands U.S. Immuno-Oncology Center Of Excellence To Strengthen Its Precision Medicine Offerings

Cerba Research established its United States presence as a leading clinical diagnostics and clinical laboratory services provider when it opened a New York facility 20 years ago. To further support our global client base, Cerba Research recently expanded this facility — now our U.S. Immuno-Oncology Center of Excellence — which allows us to provide even more comprehensive, integrated central lab services, specialty lab and biomarker solutions, and diagnostic services worldwide.

Over one weekend in July, with no loss in activity, Cerba Research U.S. moved into a 30% larger facility, giving the lab 35,000 more square feet than before. To make the best use of that space, the U.S. team brought in additional state-of-the-art equipment, expanded its testing, sample handling, and logistics areas, and welcomed additional scientific and operational experts.

“It’s a new space with a lot of light and a lot of color,” says Chief Operating Officer Nele Langenaken, who founded Cerba Research U.S. in 1999. “Overall, it provides a clean, inviting, positive environment, which helps improve efficiency and motivation among staff, as well as helps us attract and retain top scientific talent.”

Cerba Research U.S. will maintain its close partnership with Northwell Health, the largest laboratory in the region. With more than 75 pathologists and a lab that processes more than 30,000 tests per day, its support allows Cerba Research U.S. to manage rapid turnaround and large-volume requests.

That said, its expert scientists and state-of-the-art equipment make Cerba Research U.S. a first choice for precision medicine clinical trials. “The industry is moving from quantity to quality and from routine to specialized,” says Cerba Research Chief Executive Officer Mario Papillon. “Nele created an ideal environment for customized assay development and validation for R&D projects.”

The most exciting updates to Cerba Research U.S. include:

Triple the flow cytometry capacity. The expansion allowed Cerba Research U.S. to more than triple its complex flow cytometry capacity. Equipment additions include automated flow cytometers and full spectrum machines that demonstrate up to 40 colors.

“We not only expanded our capabilities, we also optimized the process and created space for a new level of excellence in flow cytometry,” says Langenaken.

Quadruple the PBMC capacity. Peripheral blood mononuclear cells (PBMCs) are critical components of immunology, infectious disease, and oncology research. With the expansion, Cerba Research U.S. increased PBMC and cell isolation capacity to handle up to four times more sample volume than the previous location.

New histopathology immunohistochemistry (IHC) lab. For the first time, Cerba Research U.S. contains an in-house histopathology lab with tissue processing, cytology, and IHC solutions for biomarker discovery through to clinical validation. Our IHC capabilities include automated, multiplex, and specialized IHC.

Increased kit production. Cerba Research U.S. increased kit production by 40% in 2021 compared to this time last year. The expanded facility will allow it to expand that production even further.

Increased sample reception and storage. The expanded Cerba Research U.S. laboratory receives between 8,000 and 10,000 tubes per day. We expect that number to increase by 20 to 25% over the next few years. Additional storage capacity includes temperatures from ambient to -20°, and -80° C, with available liquid nitrogen, all centrally monitored by a temperature monitoring system.

An even stronger team. With the expanded facility comes an expanded team. Additional scientists and operational experts give the U.S. team the depth to handle even the most complex projects.

The expanded flow cytometry, PBMC, and IHC capabilities give the U.S. CoE an even broader global footprint with which to serve immuno-oncology clinical trials. The expansion complements CerbACT Asia, Cerba Research’s other immuno-oncology Center of Excellence, which offers cutting-edge technology in FCM, histopathology, IHC, and NGS sequencing from a purpose-built facility in Taiwan.

“We have a substantial team of flow cytometry scientists in the U.S., all with high international profiles,” says Papillon. “Combined with the clinical expertise of Northwell Health, our capabilities in North America are remarkable.”

As part of a network that includes seven offices and access to over 400 labs across five continents, you can be certain no matter how global your trial, Cerba Research has the capabilities and capacity to support your projects from early research through to commercialization.

Cerba Research, a strategic provider of diagnostic solutions, supports drug development by leveraging patient data and scientific insight to optimize R&D and commercialization globally. Providing early phase research, clinical development through central laboratory and diagnostic testing, assay and biomarker development and validation — through our global network of specialty laboratories. We partner with government agencies, non-government organizations, as well as pharma and biotech organizations to change the shape of clinical development, and advance healthcare.
Cerba Research is part of Cerba HealthCare, a leading player in medical diagnosis.

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