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Melanie Fein, M.D., CPI, Joins Spaulding Clinical as Director of Medical Strategy and Oversight
July 25, 2023
WEST BEND, July 24, 2023 – Spaulding Clinical, a full-service Phase I clinical service provider, announced that Melanie Fein, M.D., CPI, a highly experienced and dedicated medical director and certified physician investigator, has joined the esteemed team as director of medical strategy and oversight.
The addition of Dr. Fein further strengthens Spaulding Clinical’s commitment to conducting high-quality clinical trials and advancing medical knowledge. Her wealth of experience, dedication, and passion for the field will enhance the organization’s capabilities in bringing innovative treatments to patients.
Dr. Fein has over 18 years of clinical trial experience and has been involved in the conduct of over 360 clinical trials in various phases in healthy and special populations, with a focus on early phase and first-in-human trials. Her areas of expertise include facility development, conduct of clinical trials, clinical trial oversight, strategic planning, FDA and facility audits, research staff training and mentoring, and the setup, implementation, and supervision of operational, clinical, and quality control systems and process improvements for clinical trial centers.
As a valuable addition to Spaulding Clinical, Dr. Fein brings skills in sponsor collaboration from feasibility through study close-out, developing strategic relationships with clients and specialty physicians, safety assessments and reporting, protocol compliance, training program design and implementation, and operational clinical and quality system development, oversight, and support. Her track record showcases her commitment to delivering high-quality, timely trials while ensuring compliance with protocols, SOPs, GCP, and ICH guidelines.
Dr. Fein shared, “I am thrilled to be joining the Spaulding team and excited to embrace both the present and a future of unlimited possibilities in our pursuit of ongoing excellence whilst contributing to improving the lives of patients and families worldwide.”
Dr. Fein received her Doctor of Medicine from the University of Witwatersrand Medical School in Johannesburg, South Africa, and completed her residency in Miami, Florida. She is board certified in family medicine and is a certified physician investigator. Prior to joining Spaulding, Dr. Fein was medical director and principal investigator at High Point Clinical Trials Center, Covance, and Comprehensive Phase One.
About Spaulding Clinical Research
Founded in 2007, Spaulding Clinical is a full-service, state-of-the-art paperless Phase I clinical pharmacology unit. Our facility, originally a hospital, features fully integrated bedside electronic data capture and sets the standard for patient care. We specialize in IND-enabling clinical pharmacology studies, cardiovascular safety, and clinical proof of concept. We provide expertise on study design, offering in-house medical writing, clinical data management, biostatistics, project management, clinical laboratory, and PK/PD analysis. For high-quality data to inform your decisions, Think Spaulding First. To learn more, visit spauldingclinical.com.