Sarah McLeod, M.S., consults with medical device and biomedical companies to discover the most effective ways of meeting their research data quality objectives. This encompasses a range of interventions from training clinical research staff in data acquisition to monitoring clinicians for protocol adherence to reporting clinically significant outcomes for study report inclusion.
Qualitative analyses of medical records, product complaints, and user adverse events (Georgetown University, NIH/National Cancer Institute, Orlando Clinical Research Center, Rx Trials, Inc., FDA [2002-2015]) is the foundation of her therapeutic expertise for quality assurance in the biotechnology arena (Stryker, Memorial Sloan Kettering Cancer Center [2015-2018]. Stryker transitioned Sarah from pre-market pharmaceutical research environments to post-market medical device responsibilities. Here she applied her authoring skills to Device History Reviews and Standard Operating Procedures. Shortly after that contract concluded, she relocated to NYC to support in vitro diagnostic manufacturer, SIEMENS, with its regulatory efforts using internal and external clinical study reports to write deadline-oriented reports of clinical performance, scientific validity and state-of-the-art assessments. She continued this supportive work for Abbott Rapid Diagnostics. [2018-2022]
Given the similarities in duties she has held in positions with SIEMENS and Abbott in terms of detailed clinical literature reviews, post-market vigilance database searches, and developing reports that have received notified body approval, Sarah began supporting Nerac January 2023 with its medical writing needs in keeping with EU MDR 2017/745 for medical device regulation and EU IVDR 2017/746 for in vitro diagnostic device (IVDD) regulation.