Clinical Research Department
AWRI Clinical Research staff support researchers and patients who participate in trials by providing centralized management and oversight related to the conduct of clinical trials.
By offering a variety of services that facilitate and strengthen research, Clinical Research provides a comprehensive infrastructure that ensures high-quality, efficient clinical trials.
Clinical Research Department
Study Coordination Services
Study coordinators and nurses provide support to the clinical team for activities related to identification, recruitment and enrollment of patients into studies. In collaboration with providers, the team ensures that each patient’s care is managed according to the protocol and any adverse events are recorded. These research professionals also take responsibility for timely, accurate collection and reporting of data.
Regulatory Support
Our regulatory specialists work closely with investigators, study teams, sponsors, and institutional review boards to help streamline the startup process, maintain study readiness, and ensure that all regulatory requirements maintain accuracy. From the creation of the first protocol and informed consent documents, through any amendments and continuing reviews, their expertise helps safeguard ethical standards, protect participant safety, and support the overall success of studies.
Investigational Drug Management
• Initiate and monitor investigational drug studies to ensure compliance with institutional, federal and state regulatory guidelines
Feasibility Review
Comprehensive protocol review and facilitation of applicable study feasibility reviews:
• Institutional, Clinical and Scientific feasibility
• Safety, Ethical and Regulatory feasibility
• Operational, Financial and Legal feasibility
General operational activities within the Clinical Research Office include developing policies, standard operating procedures and best practices related to clinical trial activities. Contact the Clinical Research Team AWRI.Inquiry@Ascension.org.