Central Nervous System

100% Dedicated to the Art and Science of CNS Drug Discovery

Accelerate your neuromuscular disease study with BBMCT’s noted medical and regulatory experts, highly experienced clinical trial management teams, central labs, and imaging core labs

Diseases characterized by neuromuscular degeneration are particularly challenging when it comes to study design and endpoint selection. That’s why you need a trusted partner that has the scientific leadership, operational execution and comprehensive services in place to help accelerate your compound to approval. Our physicians and staff have experience in rare disease and in particular diseases that impact neuromuscular function such as:

• Charcot Marie Tooth Disease
• Duchenne Muscular Dystrophy
• Familial Amyloidosis Polyneuropathy
• Mucopolysaccharidosis
• Multiple Sclerosis
• Muscular Dystrophies
• Myasthenia Gravis
• Myotonic Dystrophy
• Pompe disease
• Spinal Muscular Atrophy

British BioMedicine Clinical Trials (BBMCT)

The BBMCT Difference for Neuromuscular Disease Studies:

• In-house neurologists, child neurologists, regulatory experts, imaging experts, and clinical operations professionals that are skilled in neuromuscular disease studies
• Extensive expertise in gene editing, gene transfer technology, and other advanced therapies, along with the additional proficiency in submissions required to ensure regulatory compliance
• Specialized project teams that can leverage site relationships and utilize novel endpoints such as actigraphy, pulmonary function testing, physical function testing, and imaging to ensure efficient study execution from study start up through completion of the clinical study report (CSR)
• Partnerships with endpoint training and oversight groups and in-house data management programming to improve trend oversight
• Established processes to procure assessment related study supplies
• Integrated imaging and ECG core lab with an end-to-end suite of global imaging services ensuring imaging components are seamlessly incorporated into the complex structure of the overall trial
• Central labs with safety and biomarker analysis to support neuromuscular disease studies
• Integrated bioanalytical lab and clinical pharmacology unit to streamline development
• Full-service information design team that supports study branding – adding credibility and cohesiveness to study messaging
• Multi-dimensional recruitment model that enables us to implement customized recruitment and retention strategies that identify, recruit, and retain challenging patient populations
• Experience in complex drug delivery, such as intrathecal/ intraparenchymal dose administration and CSF collection processes

British BioMedicine Clinical Trials (BBMCT)

Neurology/central nervous system (CNS) and psychiatric clinical research is a key therapeutic focus for BBMCT. Well-established Sponsor relationships, exceptional clinical operations, and committed study teams drive your success. BBMCT has built a team of experienced medical, clinical, and regulatory experts who have been involved with the management and execution of neuroscience trials around the world. All team members are involved from project initiation to completion, producing truly seamless drug development.

Our medical, regulatory and operational experts provide strategic leadership throughout your program to streamline and accelerate product approval. Our neuroscience clients benefit from:

• Medical experts including neurologists and psychiatrists who provide the strategic direction of study design and planning, train operational staff, work with Primary Investigators (PIs), provide medical monitoring services, and meet with regulatory agencies for neuroscience projects
• Global trial management teams with extensive experience managing and executing neurology and psychiatry trials
• In-depth knowledge of screening tools and rating scales and will provide oversight for rater services including subjective assessments, inter-rater reliability, and scale validation
• Well-profiled network of sites with neuroscience experience to support effective enrollment and data quality
• Long-term relationships with successful, experienced sites, networks, and key opinion leaders (KOLs)
• Broad experience conducting Phase I-IV clinical trials spanning adult and pediatric populations