Key Staff
Michael Bailey Since joining the staff in 1992, Michael has had the opportunity to contribute in all services areas of BSI. In 1995 he joined BSI’s Department of Clinical Data Management as project manager where he administers all aspects of clinical trial data management. Michael is responsible for monitoring and reassigning workloads so that tasks are completed on time, assuring the quality of the work produced, keeping clients informed of project status, and responding to client requests. Michael developed the automated clinical vocabulary-assignment platform and continues to develop more accurate, consistent, and efficient vocabulary assignment methods. Michael is also very active in the Department of Quality Assurance, providing quality assurance services for human and veterinary clinical trials, bioanalytical studies, and analytical methods validation. Michael holds a B.S. in Pharmacy with masters-level education in medicinal chemistry and drug design.
Pat directs the staff of the Quality Assurance Services department and is an active auditor. He coordinates auditor activities, interprets regulations, negotiates and prepares budgets, and develops and reviews departmental standard operating procedures. Since joining BSI in 1994, he has performed regulatory compliance audits and evaluations, reviewed raw data and archival records, conducted third party audits of clinical and nonclinical study documentation, and developed methods and performed data validity verification audits. Pat has more than 20 years of experience as an analytical chemistry laboratory supervisor, research associate, instructor, and technician. He holds a B.A. in biology; has completed postgraduate work in biochemistry, physical chemistry, and mathematics; and is a Registered Quality Assurance Professional in Good Laboratory Practice.
Susan has been the Director of Medical and Scientific Writing since 1997 and manages all of its personnel and activities and sets the departmental budget. Susan has 20 years of experience writing and editing scientific, environmental, and technical documents and has spent much of that time in supervisory positions. She has been the Principal Investigator for the National Toxicology Program’s Technical Reports Preparation Support Services Contract since 1996 and has managed NTP Report production since 1993. She has also managed projects for BSI’s pharmaceutical, environmental, and engineering clients. Before joining BSI in 1992, Susan was an environmental projects manager for a consulting firm and a Project Officer for the Environmental Protection Agency. Her responsibilities included managing personnel and writing environmental audit reports, standard operating procedures, quality assurance project plans, and sampling plans. Susan holds a M.A. in political economy with an emphasis in environmental policy.
Lynn M. Harper Lynn has been involved in all aspects of preparing National Toxicology Program Technical Reports including writing and editing, quality assurance, project scheduling and coordination, and staff development since joining BSI in 1991. She has reviewed portions of Food and Drug Administration (FDA) submissions for editorial consistency and readability. She has over 20 years of experience writing and editing scientific and engineering documents, standard operating procedures, Federal Register notices, technical art, procedure and style manuals, and proposals for contractors employed by the Departments of Defense, Energy, and Health and Human Services. Lynn holds a B.S. in solar engineering technology.
Robbin is Director of Drug Development Services and is responsible for study protocol and method development as well as oversight of contracted research for submission to regulatory agencies. She first worked for BSI in 1993-1994 as a study auditor and has experience in quality control and quality assurance in the food and medical device industries. She holds B.S. degrees in Biology and Chemistry and a Ph.D. in Biochemistry. She has performed primary research leading to publication in both plant and animal pathogenesis, specializing in the molecular mechanisms controlling bacterial virulence.
Michele, Director of Finance and Administration, has been with BSI since 1987. Along with the administrative day-to-day operations at BSI, she oversees all accounting and financial procedures including payroll generation, quarterly payroll tax reporting and annual reconciliations. Michele works with other department directors to make sure project costs are tracked accurately and stay within contracted budgets. She performs client billing monthly or as milestones are reached and provides quarterly and annual statements. Michele writes business proposals in response to government requests for proposal and indirect cost agreements for government contracts. Michele also manages vendor services and contracts.
Judith C. McDowall As founder, president, and regulatory affairs manager of BSI Judith brings over 25 years of industry experience to BSI’s clients. Judith’s responsibilities include ensuring that quality systems are in place and functional, that personnel and other resources are available, and that staff understand the functions they are to perform. She monitors the quality, timeliness, and cost of project deliverables and is available to advise clients and staff. As Regulatory Affairs Manager, Judith is responsible for submitting and maintaining regulatory documents, managing regulatory submissions and correspondence, and interpreting regulations and policies of interest to BSI and its clients.
Barbara Randolph Barbara, an employee of BSI since 1987, joined the Quality Assurance Services department in 1992. In her career as an auditor, she has assessed processes, developed SOPs, audited vendors, inspected laboratory and toxicology facilities and clinical investigator sites conducting GLP- and GCP-regulated studies, and audited all types of data and reports. She provides quality assurance services for safety studies, animal clinical trials, analytical method validations, and human trials. Barbara has presented training sessions at national meetings and has served on the Society of Quality Assurance education committee. Additionally, Barbara has developed and presented customized GLP and GCP training for clients conducting research in various fields. Prior to joining BSI, she worked as a registered clinical laboratory technologist in immunohematology, hematology, and cytogenetics laboratories. Barbara holds an MBA and an undergraduate degree in genetics and is both a registered quality assurance professional (GLP) and a registered medical technologist.
Phyllis Rathman Phyllis Rathman joined BSI in 1990 and is currently a Writer-Editor of the National Toxicology Program Technical Reports. Since joining our company, she cofounded BSI's Department of Clinical Data Management in which she worked as a project manager. Phyllis has also worked for the Quality Assurance Services department providing quality assurance audits of other contract research organizations and data audits for human and veterinary clinical trials. Phyllis also has experience in SOP development and systems validation. She holds a B.S.E. degree in Biology with masters-level education in biology and toxicology.
Del C. Serbus Del has extensive experience with a wide variety of animal experimentation related to toxicology testing, and he is thoroughly familiar with the conduct of laboratory research studies and animal bioassays. Since joining BSI in 1994, Del has written, edited, and reviewed toxicology documents for submission to government agencies and incorporation into medical/scientific monographs for scientific content, accuracy, and internal consistency. He has written and edited preclinical pharmacotoxicologic summary documents for pharmaceuticals for United States and international regulatory submissions, and he has performed quality assurance audits for accuracy and consistency in regulatory documents for veterinary and human pharmaceuticals and agricultural chemicals. In his position as Senior Science Writer, he draws upon his expertise in the areas of chemistry, biochemistry, pharmacology, physiology, pathology, statistics, and toxicology. Prior to joining BSI, Del conducted biochemical and neurotoxicological research at the University of Arkansas for Medical Sciences and the National Center for Toxicological Research. Del holds a doctorate in interdisciplinary toxicology and an undergraduate degree in chemistry.
Zhaoyong Li Zhaoyong is the staff statistician for Drug Development Services. He holds a Masters in Applied Mathematics with a background in both statistics and mechanical engineering. He is responsible for SAS-based statistical design and programming, and the development of statistical output and reports based on client specifications.
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