ARIANNE is committed to quality. We have quality assurance review processes in place for all stages of your product development and we conduct audits early and at measured intervals to identify and proactively limit any impact on your program.
Site Management QA Services
Conducting audits early in the clinical stages of development identifies systematic problems with the conduct of your study, such as misinterpretation of protocols. These audits enable early intervention and corrective action to avoid preventable delays and expense in the conduct of your program.
- Our auditors have expertise in individual country requirements as well as FDA/ICH clinical research requirements.
- Our QA personnel are accustomed to working as a team with your organization. At no additional cost to clients, we share information on mutually agreed audit plans and discuss QA and compliance issues with you.
We offer:
- Individual site audits
- Document audits
- Internal system audits — audits of SOPs, documents and staff training for improvement of efficiency and compliance
- Investigator-directed audits — investigation of questionable data for clients
- Team members have hands-on experience in FDA audits
- Vendor audits of subcontractors, such as central lab investigational study materials
- QA consulting
- We can provide independent auditors when requested
Data Management QA
Quality Assurance review processes are in place for every major element of the data management process and deliverables:
- Database set up
- Validation manual
- Programmed edit checks
- External transfers
- Overall database quality
- 100% of defined critical variables reviewed
- 10% of randomly selected CRFs are 100% manually reviewed against the database at intervals throughout the study, as well as just prior to database lock
In addition, we track and review performance measures, such as query rates by type, numbers of queries and the ratio of errors to total units. We use this information to continuously improve the quality of the data management deliverables to our sponsors.
Statistical QA
Independent quality review assures statistical practices are consistent with the study’s scientific design. We plan quality into the preparation of biostatistics deliverables through our working practices:
- Programming and quality review based on written specifications
- Use of validated software and macros
- Standardized programming processes and directory structures
- Independent validation of all project-specific programming
- Quality review of all outputs for accuracy and to document audit readiness
- Senior review of all deliverables -- from protocols through regulatory submission documents
