Right Science, Right Patients, Right Data
Neurological disorders can have a lifelong impact, affecting people of all ages, from newborns to the elderly. We have conducted studies on a variety of conditions, including autism, Canavan disease, cerebral palsy, Duchenne muscular dystrophy, epilepsy, spinal muscular atrophy, multiple sclerosis, migraine, spinal cord injury, traumatic brain injury, amyotrophic lateral sclerosis (ALS), dementias, Alzheimer’s disease, stroke, chronic pain, and Parkinson’s disease. We provide monitoring services, data management support, and extensive quality assurance reviews and have worked with clinical investigators around the world to develop standardized data elements and collection tools for more than a dozen neurological disorders. In additional, we have managed several opioid clinical trials, providing clinical safety and post-marketing pharmacovigilance support to pharmaceutical clients for 12 opioid products. We have extensive experience providing an array of support services for clinical research on neurological disorders, such as:
- Monitoring Quality Assurance for National Institute of Neurological Disorders and Stroke (NINDS)-sponsored neurological clinical trials, including innovative areas such as emergency response trials
- Development of a classification system of NINDS neurological clinical trials to assess study risk
- Design, implementation, and maintenance of the Clinical Information Project System (CLIPS), an automated tracking system to manage and analyze data from human subject research projects
- Statistical and methodological support, including adaptive design
- Data acquisition, preparation, and final dataset archiving in a central warehouse
- Development and implementation of the NINDS Common Data Element (CDE) Project to assist investigators in using a core set of data and forms in their clinical trials. We helped investigators in the United States and internationally to identify and define essential data elements for clinical studies in numerous disease areas including stroke, epilepsy, Parkinson’s disease, multiple sclerosis, ALS, traumatic brain injury, spinal cord injury, and Friedrich’s ataxia. We also created sample form templates for neurological disorder CDEs, as well as a data warehouse for completed study datasets.
- Aggregation of data in a repository for the Specialized Program of Transitional Research in Acute Stroke (SPOTRIAS) network, a national network of eight stroke centers
Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.