ClinStat Consulting, LLC

medical devices

About

Our goal is to assist you to properly plan and execute your clinical strategy to assure early FDA approval and expedite your product to market. Clinstat Consulting was founded in 1999 by Patricia Hamilton, RN, MS. Patricia is a clinical expert with over 25 years experience. She is a Registered Nurse and holds a Master's Degree in Business Management. She has had extensive senior level technical and management experience delivering clinical research plans and studies on time and within budget for Fortune 500 global corporations as well as for small companies and start-ups. She has set up and managed clinical departments from the ground level and has hands on experience in all phases of developing a clinical/regulatory strategy, securing investigators, site selection, protocol development, site monitoring, generation of final reports and writing FDA submissions. Patricia and her staff are well suited to guide start-up companies or assist established firms with any or all your clinical needs.

Technologies

Outlook Microsoft Office 365 Remote

Keywords

medical device consulting clinical strategy formulation clinical project planning clinical data analysis investigator recruitment clinical study reports clinical protocol optimization regulatory pathway planning investigator site monitoring clinical report writing site selection clinical strategy medical devices clinical research project management risk management biotech regulatory strategy device clinical trials fda early approval product development regulatory guidance regulatory consulting research and development in the physical engineering and life sciences b2b investigator management clinical trial execution biomedical fda approval pharmaceutical

Location

2492 Manchester Ave, Encinitas, California, United States, 92007

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