KAI Research, Inc.’s activities of clinical safety and medical monitoring for pre-marketed drugs include:
- Developing a safety management plan,
- Safety review of study protocol and investigator’s brochure,
- Safety reporting training for investigators and study coordinators,
- Responding to questions regarding the study protocol, patient eligibility and waivers,
- Participate in safety review meetings,
- Serious adverse event report receipt, tracking, data entry, narrative writing, coding, assessment, and follow-up,
- Review of the medical and scientific literature for reports of serious adverse events, and
- Generation of expedited safety reports, generate notification to participating investigators’ of any regulatory submissions, and safety update reports; reconciliation of clinical and safety databases.
Serious adverse event case safety reports undergo a quality control check and medical review prior to being submitted to the client and/or regulatory authorities. Identification of safety related signals and trends occur during routine review of the serious adverse event, laboratory, and medication data.
Respond to ad hoc requests from the client and/or regulatory authorities. All clinical safety and medical monitoring activities are governed by standard operating procedures. Serious adverse event case processing activities are performed using KAI’s ARISg™ adverse event tracking system.
The ARISg™ workflow feature is customized to meet the business practices of this client and various administrative reports, such as a 7-day or 15-day turn-around time report, have been developed to assist in project management activities. KAI’s medical monitors periodically review safety data, and respond to enrollment eligibility and unblinding questions. KAI’s clinical safety team supports and participates in DSMB review meetings.