Cerba Research
Setting New Standards For Exemplary Clinical Development

Ms. Nele Langenaken, COO

A major area of concern for institutions and organizations involved in the road to bringing products to market is the limited resources available as a result of the pandemic and high volumes of routine diagnostic tests being performed. This has caused a bottleneck in sourcing personal protective equipment (PPE); consumables needed for sample collection such as swabs; assays used to detect or determine SARS-CoV-2 exposure and the logistics of moving samples around the globe as there are limited airline carriers flying. Another area for concern was in therapeutic trials the need to monitor participants who were known to be SARS-CoV-2 positive. As per international best practices these individuals should remain isolated and quarantined until the infection has resolved. As a result of isolation requirements, institutions and organizations have had to develop innovative mechanisms of performing these follow-up visits such as providing home nursing visits, who go to participants houses, facilitating self-swabbing by participants, and having mobile vans for participant visits at their homes. All the above require closely monitored and innovative logistical abilities. Furthermore, this all needs to be performed with continual evolving information on SARS-CoV-2 and the pandemic.

Against such a challenging backdrop, how do companies in the healthcare industry move investigation products efficiently and safely to a registered product?

This requires a partner who understands the obstacles described above and can effectively and efficiently maneuver them with innovative solutions stemming from their vast experience and knowledge of the field. That is where Cerba Research (www.cerbaresearch. com), a company that has been setting the industry standard in laboratory support for exemplary clinical trial conduct, comes into the picture. Cerba Research assists institutions and organizations in the healthcare arena fast track studies and trials by supporting all aspects of the laboratory requirement. Cerba Research can reduce study set-up timelines from the historical 10 weeks to as little as two weeks. This rapid set-up phase is hugely advantageous in facilitating the aim of getting an investigational product to market at an incredibly high pace. Cerba Research also sources materials and creates an appropriate model for institutions and organizations to identify and connect with possible participants. To ensure continual innovation and mobility of their processes, Cerba Research has formed core groups to track different aspects of the pandemic to ensure they offer clients cutting edge solutions and laboratory services during this unprecedented time across their global footprint.

Our expert scientists collaborate with our clients across the entire therapeutic development cycle and enables them to obtain critical insights faster

Led by a group of motivated individuals committed to improve health via diagnostic services, Cerba Research empowers pharma, biotech companies, NGOs and governments, in the virology space to develop personalized medicines that will potentially change the lives of people worldwide for the better. Cerba Research primarily focuses on accelerating clinical trials and therapies through the development of highly specialized custom assays, biomarker expertise, and routine and specialty testing technologies across multiple therapeutic areas. “Our expert scientists collaborate with our clients across the entire therapeutic development cycle and enables them to obtain critical insights faster,” informs Dr. Wallis, Medical Director, BARC SA, Cerba Research’s affiliated partner in Africa.

Well Prepared to Fight COVID-19

Cerba Research is well informed about the developments in the field of pharmaceuticals and routine diagnostics. Thanks to its global footprint, the company has access to data on several indications which further translates in providing the information and expertise to develop cures for other related diseases. Cerba Research has a well-established biosafety level 3 (BSL3) laboratory, which it uses for TB diagnostics. This facility is appropriately built to support the culturing and neutralization assays required in SARS-CoV-2 treatment and prevention studies, which the company offers to their clients. “Being involved with the HIV and TB pandemics in Africa means we already had the laboratory infrastructure to support the therapeutic and prevention work being done for the COVID-19 pandemic” says Dr. Wallis. She went onto say: “We have run about 250 trials on HIV in the areas of treatment and prevention and the lessons learnt from one RNA virus like HIV can to a certain extent be used to support the SARS-CoV-2 studies. The large HIV and TB household studies we have been involved with have given us an edge in the logistics needed to support COVID-19 studies and several systems for procurement and distribution were already in place, allowing Cerba Research’s partners to rapidly initiate studies.”

The organization’s vast experience on molecular assays, such as detection and quantification of viruses, has helped to support COVID-19 studies. Dr. Wallis also mentioned the work Cerba Research has in the oncology field and the state-of-the art flow facilities the company has, which are also available for COVID-19 immunogenicity studies. Cerba Research Scientists are well-versed in flow cytometry and immunology, both of which are advantageous in unbundling the host immune responses to SARS-CoV-2. “Our flow capability, next generation sequencing and strong molecular expertise has really helped us with the challenges that came with the pandemic of COVID-19,” she adds.

Dr. Carole Wallis, Medical Director, BARC SA

What’s more? Cerba Research’s global access to industry-leading laboratories and demographically rich data is driving the development of more advanced biomarker strategies and facilitating faster downstream decisions. “Together, we are shaping and propelling complex trial by leveraging our patient databases and network of scientific experts spanning five continents. This, along with custom assays and on-target protocol advice is helping in accelerating the program to market,” remarks Ms. Langenaken.

"We provide the highest quality laboratory and diagnostic solutions that leverage patient data and scientific insights to shape and advance clinical trials"

Continuing the Path of Success

Elaborating on a success story of a recent implementation, Ms. Langenaken talks about a client that needed to have home care visits. Cerba Research developed a complete home care pack that was sent to the participant to collect samples. “In the past, there has been the lab, the clinical side, and the participants, and COVID-19 has changed that positioning slightly in terms of now the laboratory is directly interfacing with the participant. And we have created a lot of innovation in that space and offered it to clients to enable them to interact directly with the participant nearby, reducing the overall complexity of the study and accelerating the development of new drugs that they have,” she adds.

While several factors are consistently playing a significant role in Cerba Research’s continued success, the firm’s core values, and the team’s dedication has always enabled them to soar ahead of competitors. They go the extra mile to truly understand their clients’ requirements and develop personalized solutions that fulfil their objectives. Every client is given the same priority, irrelevant of their size or business. Cerba Research’s entire team is instrumental in finding and delivering solutions, services, and support that align best with the clients’ needs. Furthermore, Dr. Wallis strongly believes that Cerba Research’s global footprint plays a significant role in the company’s success. They comprise a global network of cutting-edge laboratories that provide a full portfolio of laboratory testing, anchored by seven centres in the Americas, Europe, Africa, and Asia-Pacific regions.

Today, bolstered by its valuable partnerships and many success stories, Cerba Research has established a strong presence in the infectious disease’s arena. The company seeks to further strengthen its position by enhancing its services and making them more robust. At the same time, Cerba Research is also looking to expand its logistics and home health services. “Speed and efficiency are key to excelling in today’s marketplace. We are here to assist clients in uncovering crucial insights and achieving holistic and integrated laboratory solutions that simplify their drug development journey,” concludes Ms. Langenaken.