Quality Management & Regulatory Compliance
Our Quality Management program is based upon Juran's Quality Trilogy that emphasizes planning for quality, controlling quality, and providing a mechanism of assurance and improvement.
Our Quality Management Team has extensive experience in Regulatory compliance, data quality assurance and for-cause audits in support of clinical investigations, product defence and litigation. The group has extensive international and multi-lingual experience.
The QM Team provides a comprehensive program of internal quality planning, control and assurance for all full-service projects as well as stand-alone QA services.
The internal program is based upon a 22-point checklist covering the entire study process from protocol design to compilation of submission components or publication. In addition to formal audits conducted under the Quality Management Plan, we utilize electronic data reporting as a means of monitoring the quality and timeliness of study procedures. Reporting includes administrative data (such as screening reports, site progress reports) as well as study data. Our electronic reporting generally serves as a good early warning that may signal QA concerns, and based on early data we often adjust the frequency and/or immediacy of formal QA action.
The stand-alone services include contractual services for
- GCP auditing
- Process improvement
- QA consultation
Health Decisions' stand-alone Quality Management services are unique to the industry in that:
- The number of clients we serve is restricted to ensure that their aggressive timelines are not jeopardized;
- We provide prompt reporting of audit findings. For most audits we provide preliminary results within 24 hrs of audit completion and a final archival report within 3 working days;
- For dedicated clients, we are available 24-7 and require less than 48 hours notice for audit activity anywhere in the world.
