At Cerba Research, previously Barc Lab, comprehensive central lab services are at our core. When you partner with us for global central laboratory services, our 35 years of experience, and industry-leading laboratories spanning five continents, our sights are centered on your trial success.
That’s why, in 2016, a midsize biotech engaged our services for the largest Phase III nonalcoholic steatohepatitis (NASH) study to date. NASH affects almost 12% of people in developed countries, with a growing number of patients progressing to end-stage liver disease. The need for NASH therapeutic agents is urgent, so we were eager to help.
Central lab services we provided for this study included:
- Global liver biopsies, slide handling, and processing for KOL investigator
- Safety analysis, patient monitoring for response to drug and placebo
- Biomarker testing
- Project management
- Site support
- Unified global study database
In NASH Screening, the Liver Biopsy Is the Gold Standard
Managing global clinical trial testing can be challenging, and NASH is an indication with real operational complexity. To succeed, we had to leverage all our experience — and a large number of NASH-knowledgeable local affiliates — to manage the scores of sites, countries, and patients involved.
Between 2016 and 2019, our work included:
>5,000 liver biopsies
>2,000 patients randomized
NA, EU, AUS, AF
NASH Study Complexity Extends Beyond Liver Biopsy Collection
Liver biopsy results are often the primary endpoint in monitoring NASH disease progression and remain the gold standard for diagnosis. In NASH clinical trials, biopsy processing, staining, and reporting are all crucial. Through experience, flexibility, and attention to detail, we were able to apply robust quality processes at every step of the complex biopsy workflow for over 5,000 patients screened at more than 600 sites in 31 countries. Our teams leveraged expertise in:
- Liver biopsy performance
- Logistics around biopsy blocks and slides
- Custom staining
- Digital imaging and software analysis of stained samples
- In-house NASH testing
- Flexibility to adjust processes toward agency updates/requirements
- Relationship building with key opinion leaders (KOL)
Reading the subtle histological changes that characterize NASH biopsies is practically an art form, mastered by only a handful of KOLs worldwide. Excellent cooperation with these top pathologists paired with skilled slide preparation — including digital imaging and analysis — ensured the consistent biopsy readings delivered in this successful study.
The Right In-House Validated Biomarker Testing Makes All the Difference
From noninvasive tests for fibrosis scoring to biochemical urine markers to liver tissue tests, NASH trials can require a vast range of validated testing, from basic to exploratory options. And with a global trial like this one, study teams rely on comparability of results and easy data access.
Because Cerba Research offers guidance and a vast portfolio of biomarkers required for NASH and other trials, our client had no difficulty obtaining what was needed. Even assays we don’t normally carry can be added and validated in-house. Generally, our biomarker testing covers:
- Genetic predisposition
- Inflammatory biomarkers
- Glycemic and lipid biomarkers
- Safety and serology
Lab Support for NASH Studies Has a Definite Learning Curve
The processes and logistics for supporting a study of this type are far from simple. However, NASH is a key indication for Cerba Research, so our quality processes and experience were primary factors for successful conduct in a global trial this large. The team established detailed operational workflows and internal monitoring with a focus on the primary endpoint liver biopsy.
Our worldwide affiliates’ regional project managers supported local requirements and helped maintain global consistency and standardization. Cerba Research’s proactive site training and monitoring reinforced sites’ compliance with protocol expectations, including quality slide production and correct blinding practices. Furthermore, a unified global study database enabled study teams around the globe to access all trial data via our online portal.
Cerba, the Central Lab Centered Around You
We believe customer-focused project management is essential to conducting a smooth trial. It took a lot of collaboration to manage every component of this project. Our SMEs and PMs communicated openly and proactively with our client throughout to optimize processes and services. Generally, the Cerba Research team is able to help with optimal biomarker selection given the study requirements, molecule, and budget. We can also help ensure the proposed protocol will be compliant with evolving FDA, EMA, or other regulatory body suggestions or regulations.
Additionally, we partner effectively with CROs offering them our NASH expertise. For instance, a joint CRO-lab offering, integrated seamlessly, can be a win-win and deliver great results and efficiencies for sponsors.
At the same time, NASH studies are notorious for high screen-failure rates and ballooning costs. At Cerba, we monitor the budget closely throughout the trial, tracking expenditures and flagging any outliers or excesses right away to address potential overages proactively.
Learnings From This Trial Help Us Anticipate Future Needs
Change is a given in clinical research, especially in indications as new as NASH. We have applied insights from this Phase III NASH trial to develop an improved suite of offerings that increases efficiency for our clients and addresses forthcoming regulatory updates. In particular, we were inspired by the new requirement for multiple biopsy readers and the expected progression to digitalization and evaluation by AI. Our liver biopsy services will soon or already include:
- Digitalized slides
- Integrated platforms
- Next-generation image analysis
- An app to improve processes
Other novel offerings are:
- Metabolomics, whereby a mass spec profile of serum metabolites is analyzed against a NASH/steatosis database. This method can be used to evaluate short interval responses to therapy, investigate a drug’s mechanism of action, or tailor a companion diagnostic.
- BioKortex, a patient-centric recruitment solution that uses the vast Cerba HealthCare patient database to save sponsors time and expense through customized digital tools, patient-enriched data, and partnership with strong medical laboratory networks.
- Richer resources for site training and site performance management along with a site performance database to gauge the likelihood of success.
We expect these newer options will provide added value for our clients.
Cerba Means Certainty
Reaching a global patient base can be challenging — but across continents to rural villages, through language and customs barriers and regulatory requirements — Cerba gets the job done. Through close partnership, we provided this midsize biotech company with global access to the industry-leading laboratories, scientific experts, and skilled project management needed to support this challenging NASH trial successfully. As part of our comprehensive lab support, we processed more than 5,000 liver biopsies and had them certified by a KOL.
When you partner with Cerba Research for global central laboratory services, our sights are centered on your clinical trial. Rely on more than 35 years of experience, industry-leading laboratories spanning five continents, and six-week standard startup time. You’ll experience seamless efficiency and excellence in central lab support for your trial from The Central Lab Centered Around You.