KAI , a wholly owned for-profit subsidiary of Altarum, provided an array of clinical research support services for the National Institute of Neurological Disorders and Stroke (NINDS), which included Monitoring Quality Assurance in Institute-Sponsored Clinical Trials, through site visits, technical assistance for investigators, and assessments of operational activities as well as data quality; Development of a Classification System of NINDS Research Projects to assist senior Institute staff in their project oversight functions; Tracking of Clinical Projects through the design, implementation and maintenance of an automated tracking system, the Clinical Information Project System (CLIPS); Statistical and Methodological Support to the Clinical Trials Cluster.
Additional activities included the following:
- Provided Data Acquisition and Archiving Services to facilitate access to data in completed studies;
- Developed and Implemented Common Data Element Project (CDE) to assist investigators in using a core set of data and forms in their clinical trials. This was a major activity under this contract with the goals of reducing start-up costs and time of clinical trials. We assisted investigators around the United States and the world in identifying and defining data elements necessary to collect in a clinical study in numerous disease areas including stroke, epilepsy, Parkinson’s disease, multiple sclerosis, ALS, traumatic brain injury, spinal cord injury, Friedrich’s Ataxia, etc. We also created sample form templates, all of which are available on a NINDS CDE website;
- Created a Data Warehouse for completed study datasets from NINDS clinical trials;
- Aggregated data in a repository for the Specialized Program of Transitional Research in Acute Stroke (SPOTRIAS) network, a national network of eight stroke centers;
- Assisted Intramural Investigators with statistical analysis; and
- Conducted study monitoring for Intramural studies in multiple sclerosis, essential tremor, and other neurological conditions.
For completed extramural studies, KAI provided data archiving services, where data from completed studies were stored and retrieved for use by other Investigators.
KAI also provided data analysis and produced statistical reports in response to the Project Officer’s and Investigators' requests regarding completed extramural studies.
KAI worked with SPOTRIAS investigators to develop a mechanism for extracting data from their disparate, discrete systems and organizing the data into an aggregate database using Extensible Markup Language (XML).
We developed a data repository website for investigators and sites to access the data and reports. The methods used in this activity were innovative and provided a model for other Networks.