We Attain the Highest Standards of Quality in Immunology and Allergic Disease Assay Development & Testing
In both pharmaceutical development and diagnostic testing, quality is paramount. Accurate results are critical to patients’ health and well-being and to protecting pharmaceutical firms’ R&D investments and future revenues. IBT is committed to ensuring sample integrity and delivering accurate test results so pharmaceutical and biotechnology manufacturers can make sound decisions about ongoing drug development and physicians can make precise patient diagnoses.
IBT employs a comprehensive Quality Management System designed to ensure:
- Regulatory Compliance
- Independent Quality Assurance Unit with dedicated internal auditing staff
- Clinical trials project management and study coordination staff experienced in the demanding environment of clinical trials testing and data management
- Quality system compliance training for all laboratory staff
- Secure archiving of study records
- Computer system validation and security
- Test Result Accuracy
- Use only the best available kits and methods from licensed diagnostic reagent manufacturers as well as tests that IBT has developed and validated according to our rigorous standards
- Continually update our assays and processes to incorporate the latest discoveries and methodologies
- Employ only experienced and professional clinical, quality assurance, logistics and managerial staff
- Ensure that all employees are trained on and follow all applicable regulations, guidelines and standard operating procedures (SOPs)
- Encourage all staff members to pursue continuing education opportunities in their fields
- Sample Integrity
- Data Integrity
- Hires experienced information technology professionals to manage data, networks and computer systems
- Employs sophisticated data backup, redundancy and security measures
- Implements secure data transfer protocols
- Validates information technology systems, software and processes
Regulatory compliance is essential in successfully bringing new therapeutic agents and diagnostic testing platforms to the marketplace. Our quality assurance and compliance efforts go beyond those required of a typical clinical laboratory (CLIA-88 and HIPAA) to incorporate features of Good Laboratory Practice and other regulatory standards:
When clients send specimens to IBT for testing, they trust us to provide the most accurate results possible. To honor that trust, we
IBT places great emphasis on proper sample storage, handling and tracking to ensure that specimens are never compromised, contaminated, mislabeled or lost.
To keep your confidential, proprietary test result data private and secure, IBT: