Neurodegenerative Disease CRO

The Medpace Advantage

Gain a competitive advantage for your program by leveraging our global footprint, strategic medical, regulatory, and operational leadership, and support from our fully integrated central labs and core imaging services to enhance and expedite development.

Why Choose Medpace for Neurodegenerative Disease Studies?

Partner with a global CRO with a cross-functional collaborative model to set your Neurodegenerative trial up for success. The Medpace Neuroscience Team can support your clinical trials through:

• Vast experience successfully managing studies in rare disease indications provides the knowledge and resources to ensure success in genetic marker focused studies that must recruit and retain the hardest to find patients
• In-depth knowledge of screening tools and rating scales and experience providing oversight for rater services including subjective assessments, interrater reliability, and scale validation
• Flexible, highly-customizable ePRO solutions that are fully integrated into our proprietary data management system, ClinTrak
• Extensive experience with the different therapeutic platforms (small molecules, monoclonal antibodies, blood derivatives, RNA and DNA therapies) and routes of administration (oral, parenteral, intrathecal, intracisternal, intracerebroventricular, intraparenchymal) 

Central Laboratory Capabilities

With strategically located central laboratories in the US, Europe, China, and Singapore, Medpace has the global reach and safety and biomarker analysis capabilities to conduct neurodegenerative disease studies in concert with our full-service CRO or as a standalone service. Key highlights include:

• Extensive menu of biomarkers that use state of the art techniques, and provide results that enable patient stratification and improve prediction of drug efficacy and safety
• Scientific engagement throughout the development lifecycle from our global team of experts who have extensive central laboratory operations experience
• In-house logistical team that manages all shipments of collection kit supplies and laboratory manuals to clinical sites
• Seamless integration with a robust network of laboratory partners, providing specialized neuroscience testing such as CSF biomarkers and genotyping

Specialized Imaging for Neurodegenerative Disease Clinical Research

High-quality image acquisition and interpretation is crucial for the success of neurodegenerative disease trials. Medpace Core Labs provides comprehensive central imaging services to support participant selection, imaging endpoints and safety assessment for neurodegenerative disease trials using fully regulatory-compliant platforms. Our fully-integrated, wholly-owned imaging core lab ensures imaging components are seamlessly integrated into the complex structure of the overall trial. Key services include:

• Site assessment, qualification and training, imaging protocol optimization and standardization
• Centralized blinded assessments, including patient eligibility and safety reviews
• Advanced data processing, e.g. global and regional brain volume and atrophy quantification with MRI
• Support of multiple modalities: MRI, PET, fMRI

Extensive Clinical Trial Expertise in Alzheimer’s Disease

With decades of experience in neurodegeneration, Medpace is a trusted partner in designing and executing global clinical trials for Alzheimer’s disease and related disorders. Our global team of medical, operations, and regulatory experts understand the complexities of Alzheimer’s trials from the perspective of the Sponsor, patients, clinical investigator, and the reviewer at the regulatory agencies. As a seasoned yet flexible CRO partner, Medpace provides invaluable insights gained from managing neurodegenerative trials, including lessons learned in comparable indications, trial designs, regulatory and site interactions, and endpoint protection.  

Article

Overcoming Complexities in Alzheimer’s and Neurodegenerative Clinical Trials