Drug Safety Solutions has been acquired by ProPharma Group. We are excited to be joining the ProPharma Group team!
Joining forces with ProPharma Group will allow us to bring additional resources and expertise to our clients’ studies. Learn more at www.ProPharmaGroup.com.
Drug Safety Solutions’ team of physicians and drug safety personnel has over seventy-five combined years of experience working with pharmaceutical and contract research organizations. Our specialists have successfully handled all medical aspects of clinical trials, from phase I through phase IV. Our experience in an array of diverse therapeutic areas and trial designs enables us to review protocols and safety database collection methods to better project potential needs—and ultimately to best serve the needs of our clients.
We understand that the best medical support teams are those that can aid you throughout the course of your project. Drug Safety Solutions works as a part of your project team to bring you continual and comprehensive support, collaborating with you from start to finish ensuring that your project is completed in a reasonable time frame and meets the highest medical and scientific standards.
Dr. Gil Price – CEO and Chief Medical Officer
Dr. Gil Price is a clinical physician trained in Internal Medicine with a long-standing interest in the study of adverse drug reactions, drug utilization, drug development and regulation. He is an accomplished senior level manager with over 26 years of diverse therapeutic drug development experience. His responsibilities have included pharmacovigilance, competitive intelligence, and clinical development. Prior to his current position as CEO of Drug Safety Solutions, Dr. Price was the Director of Clinical Development for Oncology at MedImmune Inc. He previously worked in the CRO sector at ClinTrials. Dr. Price began his pharmaceutical career at Glaxo, Inc. in Research Triangle Park, NC, where he worked for nearly nine years on both the commercial and research sides of the company.
Dr. Price is a member of the American Medical Association, the Academy of Pharmaceutical Physicians, the American Society of Microbiology, the Association of Clinical Research Professionals, and the Drug Information Association.
Dr. Katherine Smith – Senior Medical Officer
Dr. Katherine Smith, a board certified pediatrician with 22 years of clinical pediatric experience, has a keen awareness of the evolving application of pharmaceutical products in the pediatric population. She continues to practice clinical medicine in conjunction with her work in drug safety. As a medical officer for Drug Safety Solutions since 2002, Dr. Smith’s responsibilities include pharmacovigilance activities for trials and post marketing, literature reviews and assessments, protocol review, medical monitoring, medical consulting, safety and coding reviews, data safety monitoring committee memberships, periodic and annual safety reports preparation and review, and serious adverse event (SAE) management. Dr. Smith is also a scientific board member of the independent institutional review board, Copernicus Group IRB. Her role at the CGIRB has sharpened her skills in critical protocol and informed consent review, and given her insight into drug safety from the subject and regulatory perspectives.
Dr. James F. Balsley – Consulting Medical Officer
James F. Balsley, MD, PhD is a board certified pediatrician and pediatric oncologist. He has over 30 years experience in clinical trial research in the clinic, government service, and the biotechnology industry. His fellowship training at Children’s Hospital National Medical Center in Washington, D.C. provided experience with all phases of clinical trials in a cooperative group setting. He served as Chief of the Pediatric Medicine Branch in the Division of AIDS at the National Institute of Allergy and Infectious Diseases in NIH, where he was responsible for the research program of the Pediatric AIDS Clinical Trial Group which conducted Phases I-III trials in children of antiviral drugs, therapies for opportunistic infection, and early HIV vaccine candidates, and for the clinical trials of AZT in pregnant women. During the Gulf War Dr. Balsley received extensive training in the treatment of injuries from biological and chemical warfare agents. He later served as Senior Medical Director at MedImmune, Inc., and was responsible for programs involving clinical development of preventives for viral infection. Since 2002, he has worked as an independent consultant focusing on clinical trials, medical monitoring of drug and vaccine programs, membership on IRB’s, Safety Monitoring Committees, and Data Safety Monitoring Boards.
Kristen Eagle, R.N. – Senior Drug Safety Consultant
Ms. Kristen Eagle is a registered nurse with a clinical background in intensive care, pre-operative, and oncology nursing. She has worked as a Drug Safety Consultant for Drug Safety Solutions since 2002, managing the pharmacovigilance activities for multiple studies and providing postmarketing safety support. She was previously employed in the clinical trial industry as an oncology site study coordinator, where she participated in all aspects of clinical trial management including enrollment, informed consent, and safety and data management. She previously served as a Product Safety Associate for Inveresk Research in Research Triangle Park, NC, where she managed the safety reporting for several large oncology and asthma studies and was promoted to senior safety associate.
Pia Mikkelsen Lynch, M.D. – Medical Team Member
Pia is the President and Managing Director at Lynch Consulting Group. Prior professional experience includes Vice President of Global Clinical Affairs at Novoste Corporation, Director or Clinical Research at Elan Pharmaceutical Research Corporation, Medical Project Management at Worldwide Clinical Trials, Inc., and Medical Consultant at Integrated Micro Technologies, Inc. Pia’s responsibilities at Drug Safety Solutions include pharmacovigilance activities for trials protocol review, medical monitoring, medical consulting, safety and coding reviews, data safety monitoring committee memberships, and serious adverse event (SAE) management.
The Drug Safety Solutions’ network of professionals also includes a team of experienced Medical Writers. Please Contact Us for more information.