Accelerating Therapies for Neurological Conditions

We provide end‑to‑end support across neurology programs, including:

• Biomarker strategy: Aligning biomarkers with disease biology, mechanism of action, and clinical endpoints early in development
• Custom assay development: Designing and validating assays for novel neurological targets and specific regulatory contexts
• Post‑marketing support: Enabling long‑term safety monitoring, biomarker follow‑up, and real‑world evidence generation.

We bring deep, indication‑level expertise across a broad spectrum of neurological disorders, including neurodegenerative, neuroinflammatory, infectious, and rare neurologic diseases. Our scientific teams understand the pathophysiology underlying CNS and peripheral immune involvement, enabling study designs and assays that are biologically relevant – not generic.

Through close collaboration with sponsors, we align laboratory endpoints to the mechanism of action, ensuring generated data directly informs hypotheses around disease biology, target engagement, and treatment response.

Neurologic diseases are defined by high biological and clinical variability, and we address this through biomarker‑driven strategies that support meaningful patient stratification.

We integrate multidimensional data, including immune phenotyping, circulating biomarkers, and clinical variables, to identify relevant subpopulations and reduce noise in early‑stage studies. This approach helps sponsors distinguish biologically meaningful signals from background variability, strengthening confidence in exploratory and proof‑of‑mechanism decisions.

We prioritize endpoint sensitivity, reproducibility, and longitudinal consistency, which are critical in neurology trials where disease progression can be slow and subtle.

Our standardized workflows and quality controls are designed to detect small but meaningful biological changes over time while minimizing site‑ and operator‑driven variability. This enables sponsors to assess therapeutic impact earlier and with greater confidence, even in small or heterogeneous populations common in neurology programs.

Neurology trials increasingly rely on multimodal data integration, and we are built to support this complexity. Through standardized laboratory workflows and advanced analytics platforms, we help unify immune, cellular, molecular, and clinical data into a coherent analytical framework.

Our approach emphasizes traceability, standardization, and transparency, ensuring that complex datasets can be interpreted clearly and communicated effectively to internal teams, governance committees, and regulatory stakeholders.

We focus on early decision confidence, a critical need in neurology, where late‑stage attrition remains high. By connecting high‑quality data generation with robust, reproducible analytics, we help sponsors establish stronger mechanism‑of‑action evidence, validate biomarkers, and identify risks early in development.

This end‑to‑end approach supports more informed go/no‑go decisions, reduces uncertainty as programs advance, and helps prevent costly late‑phase failures.

Cerebrospinal fluid (CSF) biomarkers are central to neurology clinical trials, particularly for neurodegenerative conditions. Cerba Research measures core CSF biomarkers, including total tau (t-tau), phosphorylated tau (p-tau at multiple sites), amyloid beta isoforms (Aβ42, Aβ40, Aβ42/40 ratio), neurofilament light chain (NfL), and emerging biomarkers, including GFAP. Assays are validated for low-volume samples typical of CSF collection and aligned with regulatory expectations for use in Alzheimer’s, Parkinson’s, ALS, multiple sclerosis, and other neurodegenerative trials. Multiplex platforms enable simultaneous measurement of multiple biomarkers from a single sample.

Gene therapies for neurological conditions typically require analytical support spanning anti-AAV antibody screening for patient eligibility, vector copy number and biodistribution analysis, transgene expression measurement, immunogenicity monitoring (ADA, NAb), and long-term persistence assessment. Cerba Research supports gene therapies for neurological conditions, with IVDR-compliant assays available for late-phase studies and 24/7 sample logistics for time-sensitive analyses.