KAI Research, Inc., a wholly owned for-profit subsidiary of Altarum, was awarded the Clinical Trials Operations Support Center to provide an array of clinical research support services for the NIA. Activities in this contract include the following:
- Clinical Trials Operations Support and Quality Assurance – KAI provides technical and administrative assistance for interpretation and implementation of the guidelines for specific clinical trials, including trials focused on geriatric populations; conduct assessments of quality assurance procedures in NIA-funded clinical trials and conducts clinical site visits to monitor participants’ safety and data quality in designated clinical trials. KAI staff developed a Web-based toolbox and associated guidelines for clinical trial investigators to ensure data quality and integrity of NIA funded clinical trials. KAI also assists NIA with establishing a biological sample and data repository for clinical samples and data from completed clinical trials.
- Safety-related Operations Support – KAI staff reviews, monitors, and recommends changes (if needed) to the human subjects’ safety surveillance programs in the NIA-funded clinical trials. KAI has developed an online, multimedia safety surveillance training module for clinical trial investigators and procedures for reviewing awardees clinical trial materials; performs ongoing review and standardized medical dictionary coding of Serious Adverse Events (SAEs) and provides Data and Safety Monitoring Board (DSMB) support for the NIA.
- Statistical and Methodological Consultation – KAI staff reviews and makes recommendations to NIA ongoing NIA-funded clinical trials in areas such as study design, sample size calculations, statistical analysis plan, methodology, and randomization procedures. KAI also provides support for de-identification and archiving public use datasets from completed clinical trials.
- Training of NIA Staff in Clinical Trials – KAI has developed a training module on operations, management, and oversight of clinical trials for NIA program staff and provides consultations to the NIA Program staff on policies and procedures related to clinical trials.
- Maintenance of the NIA Human Intervention Studies Database- KAI evaluated and modified the structure of the NIA Human Interventions Studies database and developed and implemented a more robust web-based system with extensive searching and reporting capabilities to assist NIA program staff in managing their scientific portfolio. The database is actively maintained by KAI to reflect changes and to keep it in sync with the NIH IMPAC II application data.