Our Standards
The services we provide are governed by our proven standards created from the years of experience of our experts. Our standards are some of the best business practices propelled by requirements of the clinical research governing agencies. The main goal of ensuring we operate by standards is to help maintain levels of quality, safety, reliability, efficiency, compatibility, and interchangeability at economical costs.
In our data management processes and systems, we utilize standards, requirements, and guide-lines that are adopted by regulated and surrounding industries:
FDA (Food and Drug Administration). 21 CFR part 11, its guidelines and preamble
- are our fundamental tools in ensuring that our systems, services, and processes are within the acceptability standards of federal regulations.
- ANSI (American National Standards Institute). In further ensuring are at optimum reliability, we utilize practices used by ANSI and its National Accreditation Program (NAP).
- CDISC (Clinical Data Interchange Standards Consortium). CDISC was previously a special Interest advisory board to the Drug Information Association (DIA). Their mission is consistent with that of ADB Consulting: “committed to the development of standards to support the collection, processing, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development”.
- ISO 9000 (International Organization for Standardization). ISO 9000 Standards has become internationally accepted; ADB consulting has adopted these standards and continues to ensure that our processes are well within these guidelines.
- Application Users Group. ADB Consulting values global users and their experiences with the applications that we employ in our solutions. This interaction allows us to continually improve our system design, structure and use.
Our standards are enhanced by our extensive knowledge and experience makes ADB Consulting a powerful force working for our clients.
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