Cerba Research
Driving Global Clinical Success through Laboratory Excellence

Modern drug and vaccine development hinges on one essential truth that life-changing therapies are born from scientific data that must be trusted across continents. As trials become increasingly global and assays more complex, sponsors struggle to maintain data quality, regulatory compliance and operational harmony across multiple laboratories. Success depends on not just great science, but the ability to ensure precision and speed at scale.

Cerba Research empowers clinical trial sponsors, pharma and biotech companies and contract research organizations to translate their vision into life-changing therapies for patients worldwide.

State-of-the-art specialty and central laboratory solutions are at the heart of its offerings. The solutions help clients run the world’s most complex clinical trials with accuracy, scale and scientific intelligence. Cerba Research drives breakthroughs across high-impact therapeutic areas, from virology and vaccines, oncology and immunology to infectious diseases and gene therapy. With the integration of Viroclinics-DDL, its laboratories specialize in infectious disease research, offering advanced virological, immunological and molecular assays under one roof. They are equipped with a wide range of testing, from routine safety to advanced molecular and genetic assays.

A robust portfolio of specialty laboratory solutions supports the full drug and vaccine development lifecycle, helping clients from the preclinical to post-marketing and approval phases. The deep expertise and agility of a specialist laboratory combine with the capacity, breadth, and global reach of a central lab.

“Our goal is to support complex clinical trials through deep scientific knowledge and scalable infrastructure,” says Maria Fotiu, CEO and managing director.

With laboratories across five continents, clients can tap into services that include protocol review, kit design and sample handling. Additional services include biobanking, testing and reporting, all delivered through a unified global database. Cerba Research maintains BSL-3 certification across multiple sites. This ensures global access to high-containment facilities that support customers wherever their studies are conducted.

All laboratory services are backed by standardized, harmonized workflows. Validation is a defining force, enabling Cerba Research to establish and drive rigorous standards across both internal and partner labs. The same capabilities and quality are delivered across regions, providing a unified experience that reduces protocol deviations and accelerates trial timelines.

Driving Scientific Precision across Therapeutic Frontiers

Cerba Research’s specialty services span preclinical and bioanalytical domains. Leveraging its extensive industry expertise, it excels in custom assay development and validation, biomarker discovery, data insights and compliance.

As part of its pre-clinical services, the team focuses on evaluating safety and efficacy in early-stage development for customized, validated assays that are seamlessly integrated into clinical workflows.

Its bioanalytical solutions provide support for phases, including pharmacokinetics, immunogenicity testing and biomarker analysis. The services are backed by regulatory-compliant labs and a dedicated scientific team that ensures continuity and deep therapeutic expertise across biologics, vaccines, and advanced therapies.

In a powerful example, the team collaborated with an oncology sponsor that faced delays due to inconsistent biomarker data across North America, Europe and the Asia-Pacific region. Cerba Research deployed harmonized assays across its global laboratories, centralized data review and introduced predictive analytics to streamline trial execution. The client witnessed a 30 percent reduction in protocol deviations and significantly accelerated enrollment timelines.

Amplifying Cerba Research’s impact is the depth of its scientific engine. The breadth of its capabilities unfolds even further, drawing on a suite of capabilities like flow cytometry, genomics, histopathology and cytogenetics. Advanced platforms, such as Cytek Aurora, enable precise immunophenotyping, CAR T-cell enumeration and receptor occupancy. Next-generation sequencing, including whole-genome, exome, ctDNA, TCR/BCR profiling, and custom oncology panels, delivers operational agility and scientific depth. Enhancing its value proposition are histo-cytopathology and spatial biology tools that translate tissue data into meaningful insights. With plans to invest in spectral flow cytometry, its scientific horizon continues to widen.

Upholding Accuracy and Reliability in Every Outcome

A strong Quality Assurance (QA) team drives Cerba Research’s pursuit of scientific excellence. The QA team plays a vital role in ensuring all laboratory systems, processes and testing protocols meet the highest standards of accuracy, compliance and scientific integrity. The QA department also oversees the creation and review of standard operating procedures, conducts internal audits and hosts sponsor audits to meet with regulatory and client expectations. Client feedback is managed, and corrective and preventive actions are implemented through rigorous root cause analysis, fostering a culture of continuous improvement.

To strengthen global consistency and efficiency, Cerba Research has unified its quality operations using the Veeva Vault Quality Suite, which integrates quality management, document control and role-based training. The digital infrastructure enables seamless information sharing, faster decision-making and enhanced compliance across its global lab network. Committed to quality, it participates in international proficiency testing schemes and adheres to certifications like ISO 15189.

Cerba Research is recognized for its extensive expertise in science and R&D, strengthened by a well-established center of excellence model and the backing of its parent company, Cerba HealthCare. This affiliation connects clients to Europe’s largest specialty laboratory, providing access to over 2,000 specialized tests. A strong footprint in South Africa, ISO certification and CAP accreditations sharpen Cerba Research’s competitive edge.

Building Partnerships Powering Scientific Breakthroughs

Setting Cerba Research apart is its customizable, client-focused model, which features tailored services and cross-functional teams in science, logistics, and operations. Its client engagement emphasizes early scientific engagement, which optimizes protocol development and ensures rapid study startup and reliable endpoint delivery.

“Our approach supports clients in all ways and defines optimal turnaround times for best results,” says Fotiu.

Cerba Research initiates the solution delivery process by fostering scientific dialogue through active participation in global congresses, presentations and virtual forums, benefiting clients from the latest insights and innovations. The team closely monitors regulatory shifts that influence laboratory research and testing, including the latest IVDR guidelines. Internal experts and external advisors assess these updates to ensure accurate interpretation and application. The updates are then integrated into its laboratory processes to enhance service capabilities.

Following this, its business development and project management teams work closely with sponsors to gain a deep understanding of study objectives and design trial models that align with clinical and patient requirements. Solutions created are practical, robust and tailored to each protocol. Throughout the process, a dedicated project manager serves as the single point of knowledge and accountability, centralizing trial details and scientific requirements while acting as the internal voice of the customer. This structure guarantees continuity, responsiveness and escalation support when needed, ultimately delivering a seamless experience and successful outcomes for every trial.

Cerba Research stands as a catalyst for scientific progress, providing the consistent oversight and dedicated support necessary to ensure every clinical research result meets the highest standards and translates into successful clinical outcomes.