"BSI is a Contract Research Organization (CRO) specializing in quality assurance inspections, audits, and training; and medical and scientific writing services since 1985. We are committed to excellence and customer satisfaction. Our staff has the expertise and dedication to provide you with exceptional services and a positive out-sourcing experience."
Judith C. McDowall, President
BSIís Quality Assurance Services (QAS) department was established in 1992 and currently focuses on providing quality assurance support for Good Laboratory Practice (GLP) and veterinary Good Clinical Practice (vet GCP) studies and Quality Management Systems (QMS). QA services are customized to meet client requirements, and project scope can range from single audits to more comprehensive compliance tasks.
Since 1989, BSI's Medical and Scientific Writing has offered writing, editing, and data verification services to provide highly technical documents, primarily targeting government, pharmaceutical, and medical audiences. BSI writers and editors work closely with clients to provide professional interpretation and preparation of client data to ensure clarity, internal consistency, and scientific accuracy.
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.