The mission of START’s Regulatory Affairs Department is to gain necessary approval from the Institutional Review Board(s) to enable patients to be enrolled in investigational studies conducted by START.
This department is the critical link between START and its Sponsors.
The Director of Regulatory Affairs, Aracely Cavazos, holds a Bachelor degree in Business Administration. The regulatory department employs three additional support staff and has a combined 32 years of experience.
The Regulatory Affairs Department ensures compliance with all regulatory and industry requirements and follows U.S. Food and Drug Administration (FDA) and Good Clinical Practice (GCP) guidelines for every study. Computerized systems are accessible by all members of the organization so they have the most current information regarding studies at any given time. The department also maintains a study database with pertinent information about each study.
For sponsors, the Regulatory Affairs Department handles:
- Investigators' CVs and medical licenses
- Financial disclosure forms
- Delegation of authority logs
- Current laboratory certifications and normal ranges
Other department responsibilities include the following submissions to the IRB:
- Drafting and revising informed consent documents
- Adverse event reports
- Protocol amendments
- Continuing review reports
- Closure notifications
- Investigator’s drug brochures
- IND Safety Reports
Aracely Cavazos, BBA
Director, Regulatory Affairs
START 4383 Medical Drive, Suite 4028
San Antonio, TX 78229
Phone: (210) 593-5277
Fax: (210) 615-1075