About BSI BSI is a specialized contract research organization providing a collection of related support services to clients conducting and reporting research in the biomedical sciences. The core services of the company are clinical trials data management; biostatistics and SAS programming; quality assurance inspections, audits, and training; and medical and scientific writing. Additional services are provided for regional investigators and the animal health products industry.
Judith C. McDowall, President Judith has over 25 years of experience in the pharmaceutical industry including medical writing, new product development and registration, and regulatory compliance. She began her career at American Cyanamid Company as a Research Scientist in Toxicology Research and later became Department Head, Toxicology Information Systems. At Cyanamid she was directly responsible for the preparation of numerous pharmacology, pharmacokinetics, and toxicology summary documents for submission to American, Canadian, and European regulatory agencies. She defined toxicology testing requirements and participated in the development of project plans and regulatory strategy for the registration of drug products and implantable medical devices. Judith was an essential member of the project team responsible for implementing automated systems for collection, analysis, and reporting of toxicology laboratory data. When GLP regulations emerged, Judith developed and supported procedures for compliance, including facility and in-process inspections; data audits; protocol, report, and SOP preparation; archive administration; and toxicology software validation. She also provided GLP training for toxicology staff. Other notable assignments included proposing exposure limits for medical products and preparing supporting monographs, conducting a study in workers to assess systemic exposure to an anticancer drug, and conducting studies in volunteers to assess efficacy of surgical scrub sponges. Subsequent relocation and requests for contract services led Judith to organize BSI. After her experience at a large pharmaceutical company Judith is well acquainted with industry standards and client expectations of a CRO. Judith holds a B.A. in chemistry from Tufts University and a M.S. in biochemistry from MIT. She is a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP).
BSI was founded by Judith C. McDowall in 1985 to prepare documentation for FDA regulatory submissions. BSI began preparing peer reviewed technical reports for the National Toxicology Program in 1989. We obtained and have retained this prestigious contract because of the disciplinary knowledge of our staff in toxicology and allied fields, staff expertise in report preparation, and exceptional project management. Quality assurance services were added in 1992. Our expertise interpreting and applying GLP regulations combined with our scientific expertise encouraged us to begin providing quality assurance services for regulated research. BSI extended its quality assurance services to the GCP sphere as industry recognized the need for an independent quality assurance function for clinical research and as our involvement with clinical trials grew. The opportunity to further meet the needs of clinical drug development persuaded us to begin to offer data management and biostatistics services in 1994. Our research, technical, and management expertise enabled us to develop superior systems that assure highly accurate clinical trial databases. Moreover, we knew that bringing data management, biostatistical analysis, and report writing together would benefit our clients by shortening the time period for the completion of clinical trials.
We believe that the work we do improves the health of humans and animals. We deliver what we promise and only promise what we can deliver. We keep our clients informed. We take pride in and stand behind our work.
Biotechnical Services, Inc. 4610 West Commercial Drive North Little Rock, AR 72116 phone 501-758-6290 fax 501-753-5963
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