Clinical Research

Contact the Clinical Research Team

Clinical Research Staff

Submit Interest/Inquiry for Industry Sponsored study. Include materials or information from the Sponsor.

AWRI Clinical Research staff support researchers and patients by providing centralized management and oversight functions 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 Support Services

Study Coordination Services
Study coordinators provide support for activities related to identifying and recruiting patients for studies and entering them into studies. Study coordinators also ensure that each patient is managed according to the protocol and take responsibility for timely, accurate collection and reporting of adverse event data.

• Verifying eligibility criteria
• Obtain informed consent and enroll subject
• Collecting and maintaining study data
• Managing study participants
Regulatory Support
Specialists provide support  for regulatory management of a clinical research study.

• Coordinating and processing of regulatory documents and regulatory file management
• Submitting regulatory documents and reporting unanticipated events to AWRI committees as necessary and appropriate external agencies
• Coordinating monitoring visits and audits
Data Collection and Management 
The Clinical Research Office ensures high-quality standards for data collection and management of clinical trials by utilizing peer reviews of study documents. 

• Reviewing patient data for accuracy
• Ensuring adherence to protocol 
• Reviewing regulatory files for completion and accuracy
Feasibility Review
Comprehensive protocol review and facilitation for study feasibility: 

• Clinical/Scientific/Ethical Feasibility
• Operational/Regulatory Feasibility
• Financial/ Legal Feasibility
Investigational Drug Management
The Ascension Wisconsin (AW) statewide Investigational Drug Lead Pharmacist coordinates and supervises the activities of the staff engaged with Investigational Drug Management at participating sites. 

• Initiation, monitoring and auditing of all investigational drug studies to ensure compliance with institutional, federal and state regulatory guidelines.
Operational Support
General operational activities within the Clinical Research Office include developing policies, standard operating procedures and best practices related to clinical trial activities.