About Precision Research, Inc.
PRI leaders
Neil H. Goldstein, MD
President and Co-founder
Neil is the President and co-founder of Precision Research, Inc. He has twenty-five years of experience in Phase I-IV drug development, including the planning and execution of numerous clinical studies and the production of clinical study reports, publications, NDA and BLA submissions, launch materials, and symposia. Board certified in internal medicine and infectious diseases, Neil has clinical development experience in a broad range of therapeutic areas; and he has contributed to approved NDA and BLA submissions. Prior to joining the pharmaceutical industry, Neil had a successful consulting practice in infectious diseases. Neil received his medical degree from the University of Massachusetts Medical School, and he completed his post-graduate training at the George Washington University Hospital in Washington, DC.
Donald A. Paris
Vice President and Co-founder
Don is a vice President and co-founder of Precision Research, Inc., which opened its doors as a contract research organization for the pharmaceutical industry in May 1997. He has 40 years of pharmaceutical experience, in Phase I-IV drug and device development. During his initial 10 years he worked as a microbiologist and spent his next 15 years monitoring and managing numerous large, complex international clinical studies for Sterling Drug/Sanofi. Over the last 15 years he has performed Quality Control for regulatory agency submission CSRs, INDs, IDEs, NDAs, PLAs, INDARs, NAADRs, PSURs, ISSs, ISEs, IBs, patient narratives, regulatory agency response documents, and Expert Reports in a wide variety of therapeutic areas. His clinical experience spans the therapeutic areas of oncology agents, antivirals, anti-infectives, endocrine and bone metabolism compounds, antibacterial mouthwashes and denture cleansers, asthma/allergy treatments, surgical hand scrubs/cleansers, diagnostic imaging agents, a urological device, dental implants, attention deficit hyperactivity disorder agents, Parkinsons agents, AIDS treatments, sleep disorder compounds, and central nervous system treatments. Don is also a retired Colonel from the US Army Reserve, where he started out in 1969 as a Second Lieutenant in the Combat Engineer Corps during the Viet Nam era and retired in 1992 from the Medical Service Corps following the successful liberation of Kuwait from Iraqi control as a result of Operation Desert Storm. His final assignment had been the training and qualifying of our brave young men and women of the armed forces on the quad service (ie., Army, Navy, Air Force, and Marine) universal Deployable Medical System, known as DEPMEDS, used during the Kuwait and all recent campaigns. Don received both his Bachelor of Science and Masters of Science in Microbiology degrees from Rensselaer Polytechnic Institute in Troy, N.Y.
Nancy Sobieck
Senior Director, Medical Writing
Nancy heads the Medical Writing Department of Precision Research, Inc. (PRI). Nancy has 21 years of medical writing experience acquired in the biotech, pharmaceutical, and CRO industries. Prior to medical writing, Nancy worked in drug delivery formulation (Vestar, Inc.), clinical research (Vestar, Inc.), and academic research (Molecular Genetics and Immunology, California Institute of Technology). Nancy has served as primary writer for numerous NDA, sNDA, and BLA submissions. Together with a team composed of 2 to 12 writers, Nancy has also managed submission document planning and writing. As individual consultant and/or team lead, Nancy has written the library of regulatory clinical documents, including protocols, clinical study reports, briefing documents, regulatory responses, investigator brochures and/or updates, and patient narratives. Clear, concise, and well-organized documents are the products of the writing department at PRI.
