Dr. Paunescu, PhD, Principal

Dr. Paunescu is a Clinical Consultant who advises companies on a wide range of clinical operations and trial management including strategic clinical planning, clinical trial design, protocol development, data management, safety, quality assurance and regulatory matters. She also provides support with development and implementation of Standard Operating Procedures (SOPs).

Dr. Paunescu has over 15 years of experience in clinical operations, clinical trial management, quality assurance, and regulatory affairs. She has led pre-clinical, feasibility, first-in-man and complex global clinical trials for submission to the FDA (IDEs, 510Ks, PMAs), as well as European and Canadian agencies. She has also led successful post-approval studies and post-market registries for enhancement of data collection, and long term safety. She has overseen numerous clinical trials across a total of over 1,200 trial centers and over 10,000 patients.

Dr. Paunescu was employed in various capacities in a mix of early stage, mid-size private companies, and public companies as well as Clinical Research Organizations (CROs) and Study Centers. Having served in key roles within several companies, she brings strategic, solution-oriented tactics blended with strong outside-of-the-box thinking. Dr. Paunescu has considerable experience and understanding of research and development from early pre-clinical stages to FDA approval of a product and commercialization. Dr. Paunescu has extensive experience in vendor management, data management (with several EDC systems), safety (including Clinical Events Committees-CEC and Data Safety Monitoring Boards-DSMB), clinical budgeting, as well as direct interaction with FDA (matters related to IDE, PMA, 510K communications). 

Prior to establishing ACMP Clinical and Regulatory Consulting LLC, Dr. Paunescu has held functions such as Director of Clinical Operations and Clinical Affairs, and Senior Clinical Project Manager. She has also worked cross-functionally with multiple internal departments, such as Quality Assurance, Regulatory, and Engineering, having an influential role in the product development and clinical application. In her previous consulting capacity, she has provided clinical and regulatory support to early stage start-ups.

 

Dr. Paunescu is a creative and independent professional with strategic product development experience having worked in different therapeutic areas, including:

  • Cardiovascular:

    • Ventricular assist devices (VADs)

    • Imaging agents

    • Biologics for heart muscle

    • Acute Myocardial Infarction drug

    • Home-assist devices

  • Transplantation

    • Heart, Lung and Liver devices

  • Monitoring devices

    • Non-invasive tissue oxygenation

  • Ophthalmology

    • Glaucoma drugs

    • Ocular imaging devices

  • Oncology

    • Drugs (adult and pediatric)

    • Early cancer detection device

  • Pulmonary

    • Surgical bronchoscopes

    • Sclerosing agents

  • Hematology

    • In-Vitro Diagnostic (IVD) devices

    • Assays

 

Education Background:

PhD. Biophysics, May 2001. University of Illinois

MS. Physics, June 1993. University of Bucharest, Romania

 

Speaking Engagements:

Outsourcing In Clinical Trials, Boston 2015. Title: Outsourced Medical Device Clinical Trials in Cardiology: Risk Identification, Management and Mitigation; A Sponsor Prospective

 

About the Founder

Adelina Paunescu, PhD, Principal

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