SciLucent’s staff includes scientific, medical, and regulatory professionals with expertise and experience in all aspects of healthcare product development and marketed product support.
Ann C. Tunstall, Ph.D.
Nonclinical and Clinical Program Development and Implementation; Regulatory Strategy, Documentation, and Implementation
Ann Tunstall provides strategic insight into the research, development, and evaluation of novel and marketed medical devices, human tissue products, and pharmaceuticals. She has considerable experience in the development of clinical programs for startup companies and she has designed adult and pediatric clinical protocols and support documentation (informed consents, case report forms, etc.); recruited study investigators; collected, analyzed, and audited clinical data; conducted investigator meetings; and prepared clinical study reports. Ann's keen understanding of preclinical, biocompatibility, and clinical study objectives and methodologies allows her to prepare effective marketing approval and notification submissions including IDEs, INDs, 510(k)s, PMAs, and NDAs. Her expertise includes orthopedic, cardiovascular, neurologic, and plastic and reconstructive medical devices and cardiovascular, oncologic, immunologic, and dermatologic drugs.
