Compliance & Study Management

From discovery to regulatory strategy to submission, Experimental Surgical Services’ study management team sets the industry standard in researching and testing pre-clinical therapies, medical devices, and surgical techniques.

Our Study Directors are experts at designing and validating methodologies to suit the needs of your research, and equally adept at following standard operating procedures in accordance with the latest in proven techniques.

Compliance

Experimental Surgical Services’ facilities and actions are AAALAC accredited and compliant with USDA’s Animal Welfare Act. ESS is also compliant with performing research under the FDA’s Good Laboratory Practice regulations (GLPs).

Study Directors

Experimental Surgical Services’ team of dedicated study directors will work with you and your project every step of the way, from study design and initiation to archival. Our service oriented study directors understand that each project is unique. ESS study directors are experts in problem solving and maintaining flexibility to suit the needs of your project and timeline. The study directors at ESS regularly receive extensive GLP training, and are well versed with ISO standards.

Quality Assurance Unit

Experimental Surgical Services’ in-house Quality Assurance Unit ensures maintenance of Good Laboratory Practice compliance with regular facility, procedure and data auditing. On-site quality assurance allows for flexible scheduling of audited GLP procedures, ensuring that the GLP process is completed in an efficient and accurate manner. ESS conducts studies in accordance with GLP regulations. Upon your request, our independent quality assurance unit will monitor your study to comply with FDA regulations and ISO requirements

Consultation

Translating bench top discovery to bedside medicine has made ESS faculty experts in troubleshooting and creating real time solutions to the most complex issues. ESS offers confidential consultation services for all your medical research needs.