* Discontinued as of December 31, 2018.
BSI has provided customized and confidential contract quality assurance services since 1992. Our Quality Assurance Services staff consists of both QA industry experts and experienced researchers and educators from industry and academia. All QA auditors are also Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP). Our combined scientific education, training, and QA experience permits us to review research conducted at any point in the regulatory process. Our past service experience ranges from audit of discovery research to functioning as the lead QAU for a recent FDA CVM-approved animal health product. Our QA staff also has extensive experience with remote, web-based auditing via secure websites. Auditors attend annual external and internal training and are active members of the Society of Quality Assurance (SQA) and other professional organizations. BSI has been a Silver Supporter of SQA for over 20 years.
Scope of QA Services
- Services are always customized to meet clients’ specific need
- Compliance is assessed with GLP or veterinary GCP as applicable, or other client-specified quality standard
- Project scope can range from single audits to comprehensive Quality Management System (QMS) compliance projects
- QA professionals are ready to provide compliance risk assessments, third party audits, temporary internal QAU staff, or complete QAU support for the small CRO
- Our staff has extensive experience providing QAU audit overflow relief to sponsors and CROs
- Work can be accomplished via web-based auditing, travel to work site, or at BSI business offices
- Data integrity audits
- Protocol audits
- Contributing Scientist Report audits
- Final Study Report audits
- Regulatory submission reviews
- Facility, CRO, and Vendor qualification inspections
- Study site staff training - on-site or via webinar
- QAU support functions
- Quality Management System (QMS) design and implementation
- Risk-based process audits
- Data and database audits
- Regulatory inspection readiness assessments
- Compliance remediation activities
After your initial contact with BSI, a confidentiality agreement will be enacted. BSI Quality Assurance will discuss your needs for contract quality assurance and will prepare a work proposal and a customized cost estimate. These documents can be sent to you via e-mail, fax, or postal mail, as requested. After you have had an opportunity to review the proposal, you can contact us for clarification or changes, if desired.
Scheduling and Availability
Scheduling can begin after receipt of a signed work proposal. As a CRO serving numerous clients, availability for work can be on a first-come, first-served basis. However, because BSI QAU includes a number of experienced auditors, flexibility exists for coordinating short-term or long-term engagements.
Project work is invoiced to the client on a month-by-month basis. The first invoice is generated in the next calendar month after the work occurs. Receipts are provided for all direct pass-through expenses.