Megan Harris, MMB

Senior Associate

Ensuring data integrity and sound clinical research, from study design to evaluation and reporting of results

Expertise

Resting on more than a decade of experience evaluating clinical data in healthcare settings and clinical research, Megan supports clients with expertise in:

  • Regulatory submission documents, including protocols, investigator brochures, clinical study reports, patient narratives, and annual reports
  • Support for INDs, NDAs, and BLAs
  • Analysis of clinical trial results
  • Market analysis reports and medical communications materials
  • Quality review

Experience

Megan has provided clinical evaluation support to healthcare providers and clinical research professionals. Megan’s therapeutic areas of expertise include PTSD/depression, autoimmune diseases, general medicine, microbiology, and oncology. Her bio-pharma experience also encompasses market research support for both human and animal health companies.

As part of her Masters studies, she led a consulting project with Research Triangle Institute. This project encompassed developing a report to inform key stakeholders about the nutraceutical market in various countries including product variation based on cultural influence and governmental regulation, the role of obesity and cardiovascular health problems as market drivers, and challenges associated with unreliable labeling and biopiracy.

Prior to joining Pinney Associates in 2022, Megan worked as a medical writer and quality reviewer for more than seven years with various small and large pharmaceutical companies. Most recently, she consulted as a medical writer and quality reviewer with Dicerna Pharmaceuticals, a division of NovoNordisk. She provided support for Phase 1 and 2 studies utilizing an mRNA-based platform for the treatment of rare genetic diseases. Megan assisted in the development and review of clinical trial documents, as well as conference materials, and FDA response documents.

Education

  • Postgraduate internship, Duke Translational Medicine Institute (now Duke Clinical & Translational Science Institute)
  • PSM, Microbial Biotechnology, North Carolina State University
  • Certificate, cum laude, Clinical Laboratory Sciences, Carilion Clinic School of Science
  • BA, Biomedical Sciences, Jefferson College of Health Sciences

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