The clinical trials office at Saint Louis University supports innovative clinical investigative research at the Saint Louis University School of Medicine.
Our office provides clinical trial management for industry-sponsored trials, including the oversight of trials and input into their administrative, business, educational, regulatory and operational functions.
The clinical trials office streamlines the processing of both research study contracts and budgets with industry partners to facilitate the performance of clinical trials at the Saint Louis University School of Medicine.
The office also centralizes important administrative functions and establishes standard policies and procedures needed for the successful management of clinical trials. This ensures the ease of use and proper documentation of all trial procedures.
The primary purpose of the Saint Louis University School of Medicine clinical trials office is to improve efficiency and encourage coordination of research efforts among clinical departments.
To achieve this, the office:
- Facilitates processing of contracts and budgets through standardized policies and procedures.
- Provides training and education to clinical research personnel.
- Acts as an informational resource for all research personnel including coordinators, investigators and business managers.
- Coordinates with SSM Saint Louis University Hospital around approval processes, with particular attention to Medicare analysis and other required regulatory activities.
To accomplish its goals, the clinical trials office at Saint Louis University, with appropriate departmental input, will:
- Act as the office of record for all contract documents.
- Track the projects and contracts.
- Negotiate the terms of the contract in consultation with departments.
- Provide assistance with budget preparation and negotiation, if needed, before approval.
- Assist with compliance regarding research issues.
- Collect data for internal and external audit purposes.
- Coordinate amendments and contract terminations.
- Provide assistance to departments in the preparation of paperwork for studies.
- Maintain an informational website.
- Provide training and education to departmental research personnel and principal investigators.
- Create standard operating procedures for the administration of clinical trials.
- Provide final signature of agreements and proposals.
As the clinical trials office develops, the range of functions and operations that it can deliver may evolve in conjunction with input from departments, as well as University administrative units.
Regardless of any changes in structure, the office is committed to working closely with University investigators and other research personnel to optimize clinical research operations across the School of Medicine.