Connecting real-world laboratory data from clinical sites and digitalizing patient data – the power of Decentralized Clinical Trials (DCT) to change the trials of tomorrow

Digitalization continues to provide an impetus to move away from centralized, high-cost and difficult-to-access settings to more virtual, patient-centric and decentralized clinical trial (DCT) models. Our methods need to be more patient-centric, and we need to collaborate to find remote solutions.

Thanks to digitization, we can now decentralize clinical trials and put patient data in front of research success. In partnership with Biokortex, Cerba research will show participants of this webinar a picture of the future: how clinical trials will look tomorrow. New technologies allow us to imagine a whole new process for drug development and assays. This new way of thinking reduces costs and enhances access to data. The world is evolving fast, and we need to develop accordingly. Agility, adaptability and digitization need to be the new keywords for a more manageable and secure development.

Watch the recording of this webinar to learn more about patient recruitment for decentralized clinical trials.

The coronavirus is not the first infectious disease that has forced clinical trials to adapt. Zika, Ebola and other diseases called for the world to adjust and collaborate global research efforts. With COVID-19, the rapid spread and impact on global healthcare systems forced us to change our trial management and accelerate our processes like never before. The global research community have already discovered and developed several tests and vaccines in record time through collaboration. Yet we are still working on predictive biomarker testing to identify people who are at the most risk of developing severe symptoms, epidemiological, vaccine and genetic studies.

To facilitate testing, research, and innovation and to ensure trials continued, Cerba Research and Cerba Healthcare adapted our capabilities and facilities to push research continuity.

Watch this webinar and discover the answers to these questions:

• Did we succeed, how fast did we adapt and are we ready to face a new pandemic crisis in the future?
• How did we maintain the high security and confidence of testing, and what did our reactivity and proactivity mean in the context of a health crisis?

Pharmaceutical and biotech companies are dealing with a paradigm shift in drug development as the industry embraces more personalized, complex, and expensive cell therapies.

With some therapeutics proving ineffective in as many as 75% of patients, the need for precision medicine is clear, as is the benefit of using selection biomarkers in the drug development process where success rates can triple. Consequently, companies are balancing the increased demands for unique, esoteric testing with budget restrictions and geographical coverage.

In the quest to accelerate drug discovery to market and reduce costs, the industry continues ever further with externalization and outsourcing of drug development. Outsourcing penetration is expected to expand, as pharmaceutical and biotech companies must continue to replenish their pipeline and, hence, are incessantly looking for new sources of innovation.

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Africa has immense potential as an emerging market, and pharmaceutical and biotech companies have many avenues to leverage from Barc Lab’s African footprint for running clinical trials.

Accounting for nearly 17% of the global population, and representing a diverse population of potential patients, the African continent offers many of the best conditions for conducting clinical trials. Importantly, a number of diseases – particularly those defined as neglected and tropical – are endemic to the developing world, which includes Africa.

Despite all these advantages, Africa contributes to less than 3% of the number of clinical trials. The lack of infrastructure, cultural barriers and dedicated staff, and misunderstanding of requirements to work in the region, are simultaneously causing a burden to conducting clinical trials within Africa. However, Barc Lab believes that Africa offers an enormous opportunity for pharmaceutical and biotech companies searching for low-cost study sites, low risk of litigation and a diverse patient population. The latter makes Africa an ideal location for research, as the diseases of affluence and poverty are prevalent.

Moreover, the majority of patients to be potentially enrolled in clinical trials have not received any previous treatment for their disease – either because it is not available or they cannot afford it – facilitating patient recruitment to a great extent.

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Innovations in precision medicine have the potential to transform healthcare and create tailor-made medical solutions for patients. Clinical Trials Insight talks to Mario Papillon, CEO of Cerba Research, about how his organisation is helping patients receive novel treatments faster by making clinical trials more efficient. This agility, combined with global access to industry-leading laboratories, has been key in the fight against Covid-19, and will continue to be an imperative in the new reality in which future clinical trials will have to exist.

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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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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

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.

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.

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.