Due to the complexity of neurology clinical studies, successful execution requires careful planning, the right technology, bioinformatics expertise, and a disciplined clinical approach. We support neurology therapeutic development with over 25 years of experience designing and executing neurology clinical trials, particularly in the orphan disease space.
Biomarker Expertise and Capabilities
We incorporate advances in neurology biomarkers and biomarker detection technology to build a robust multi-parameter biomarker strategy for therapeutic development.
Advanced and Novel Biomarker Detection Platforms
In addition to many standard biomarker detection and analysis platforms (eg, flow cytometry, ELISA), Precision for Medicine utilizes state-of-the-art and proprietary technology platforms to enable detection of the most relevant and actionable neurology biomarkers.
- Quanterix® SIMOA® platform to detect low-level, blood-based, CNS-derived biomarkers to monitor neuronal pathophysiology.
- Epiontis ID™, an epigenetic qPCR-based technology for fluid-based immune cell monitoring and immunophenotyping. Epiontis ID, which has several advantages over flow cytometry, has been successfully utilized to enable clinical studies in neurology, including in multiple sclerosis.
- QuartzBioSM, a biomarker analytics engine that enables multi-parameter, multi-omic approaches to biomarker discovery and development. QuartzBio can harmonize and support the analysis of biomarker data from multiple sources and assay types while utilizing computational biology approaches to extract insight and value – including the identification of biomarker patterns correlating with disease subtypes and progression.
- Neuron-Derived Exosomes (NDEs), which are isolated from patient blood, provide a non-invasive means to monitor neuronal physiology and pathophysiology. NDEs are amenable to standard downstream biochemical assays to facilitate the identification and validation of novel diagnostic, prognostic, and predictive biomarkers.
Neurology Clinical Trial Expertise – Over 25 Years of Experience Designing and Executing Neurology Clinical Trials
Precision delivers end-to-end, biomarker-driven clinical trial execution: Rapid study startup, integrated biomarker strategies, and full-service complex global clinical trials — all to accelerate the path to market for emerging and mid-stage biopharma companies in the United States, European Union, and Asia Pacific. What makes Precision unique are the scientists, clinicians, and operational experts dedicated to biomarker-driven clinical development.
Expertise in Supporting Gene Therapy—Based Neurology Therapeutics
Successfully bringing a gene therapy to market requires a deep understanding not only of the science, but also of the specific regulatory needs unique to gene therapies. Precision provides end-to-end solutions to support development of gene therapy products.
- Leadership in regulatory strategy
- Gene therapy—specific assay design and execution
- Specialization in immunogenicity studies
- Excellence in rare and orphan disease trials (awarded Best Orphan Drug CRO for 2 consecutive years)
- Expertise to effectively coordinate both a therapeutic and companion diagnostic strategy in parallel