Clinical Trials
Clinical Trials
“To promote therapeutic advancements through research, development, and education in order to improve the clinical care of surgical patients.”
The Surgical Therapeutic Advancement Center (STAC) at the University of Virginia (UVA) is an academic research center dedicated to the development of innovations in the field of surgery in order to improve the clinical care of patients. Our collaborators include some 30 UVA faculty members whose efforts are coordinated through one central office under the direction of Robin Kelly.
Our clinical expertise in protocol development, implementation, execution, and publication extends throughout the surgical departments at the University of Virginia. Experience has been obtained in a wide variety of clinical trials (single and multi-center, including international) with many surgical specialties and related fields, including: general surgery, plastic surgery, breast surgery, pediatric surgery, surgical oncology, dermatology and radiology. The Center has particular strengths in the areas of cardiac surgery, thoracic surgery, and vascular/endovascular surgery. STAC is experienced with Phase I, II, III, and IV studies, and conducts all research with adherence to Good Clinical Practice (GCP) and International Committee on Harmonization (ICH) guidelines. The Center boasts Certified Clinical Research Coordinators and trained support personnel dedicated to the efforts of clinical research.
STAC exists through the nurturing support of a large number of industrial collaborators as a result of unrestricted grant funding and specific contractual agreements. Proprietary interests of individual sponsors are carefully protected. Intellectual property developed at the University of Virginia may be patented through the University Patent’s Foundation.
Services Available Through STAC Include:
- Regulatory strategy advice and assistance
- Protocol development and revision
- Clinical steering committee leadership
- Site selection support and maintenance
- Source document review and editing
- Case Report Form review and editing
- Clinical trial support by certified Clinical Research Coordinators with strong clinically based nursing backgrounds
- Subject enrollment and data collection according to GCP/ICH standards
- Data management and analysis by UVA Department of Health Evaluations Sciences
- Scientific publication preparation
In keeping with the mission of the Surgical Therapeutic Advancement Center to “promote therapeutic advance-ments through research, development, and education in order to improve the clinical care of surgical patients,” an additional effort is being made by STAC to expand consultation services to industry. These services are specifically designed to help new and medium sized companies with an entire support package for new product development and larger companies with particular areas of interest. Consultation services include:
- Determination of surgeon needs
- Device design
- Device testing in bench and clinical environments
- Financial sponsorship
- Clinical trial execution
- Regulatory approval
- MSL and sales personnel organization and education
- Post market clinical trials
- Advisory board participation
- Market assessment and strategy
Services can be performed off site as well as at the University of Virginia and allow STAC to provide flexible degrees of support that are tailored to each individual company’s needs. STAC has a proven track record of successful support in these areas.
Contact Surgical Therapeutic Advancement Center (STAC)
Fax (434) 243-0318
uvastac@virginia.edu
University of Virginia Health System
Surgical Therapeutic Advancement Center
P.O. Box 801370
Charlottesville, VA 22908-1370
University of Virginia Health System
Surgical Therapeutic Advancement Center
226 Elson Building
Charlottesville, VA 22908