The Clinical Trials Office serves as a comprehensive resource for initiating and conducting clinical trials for physicians on the medical staff at Baylor Health Care System hospitals.
The Clinical Trials Office benefits new and experienced investigators by conducting research studies, managing research operations and improving operational efficiencies. The office helps investigators to operate in compliance with government standards so they can focus on their core competency: research.
The office also helps to manage trials for investigators conducting numerous studies. Investigators may conduct funded clinical trials entirely through the Clinical Trials Office, while maintaining responsibility for the project, or the office can provide services tailored to the investigator's specific needs.
Services offered to all investigators:
- Pharmaceutical company and device manufacturer contact for trial placement
- Staff education on research compliance and procedures
- Research nurse and new research staff training, career path development
- Temporary staffing resource
- Policy and procedure implementation and standardization
- Budget template and financial management training
- Staff education on topics such as hazardous materials shipping, budget preparation and good clinical practice
Services offered to investigators coordinating studies through the Clinical Trials Office:
- Baylor Institutional Review Board (IRB) study submission
- Budget development and financial management
- Clinical coordination by research nurse/coordinator, including screening and enrolling study participants
- Case report form completion
- IRB correspondence and communication
- Study sponsor or contract research organization liaison
Investigators can generally apply funds budgeted and received for studies to cover the cost of services through the Clinical Trials Office. The office will charge investigators a fee for coordinating clinical trials.
In addition to resources of the Clinical Trials Office, Baylor Research Institute offers clinical investigators:
- Research opportunity identification
- Contract and budget negotiation
- Grants submission and reporting
- Execution of confidentiality agreements
- Recruitment planning
- Research billing compliance procedures and forms
- Clinical trial fund financial management
- Biostatistical resource referral