Biotechnical Services, Inc. (BSI) is closed for business.
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 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. BSI discontinued contract Quality Assurance services as of December 31, 2018.
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.
BSI closed for business on April 30, 2019 having completed all contracted work.