National Institute of Arthritis and Musculoskeletal and Skin Diseases Clinical Studies Management and Support

Kai Research, Inc, Rockville MD

Investigators

Abstract

The Assessments and Assistance for National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Clinical Studies contract supports the NIAMS with the oversight and management of its clinical research studies and clinical trials. This contract supports clinical trials and clinical research in arthritis and musculoskeletal and skin diseases. The services will include the necessary operations needed to execute clinical research studies and clinical trials from study inception to completion. Examples of these services include but are not limited to; clinical study document development and review; data and safety monitoring committee management and support; logistical and executive secretarial support for meetings; clinical site monitoring and study assessment; biostatistical review and consultation; regulatory support and consultation; Good Clinical Practice training for NIAMS staff and Investigators; and the development of electronic systems for managing clinical study information/data. The executive secretarial/logistical functions for the management of committees providing data and safety monitoring oversight to NIAMS funded clinical studies and clinical trials. In addition, this contract effort provides assistance with the conduct of clinical research to ensure data quality and adherence to good clinical practice, and Federal guidelines and policies.