ISO 9000 & AUDITS WORLD CONFERENCE ABSTRACT
Total Integrated Performance Excellence System
The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (PCC) supports and manages drug/device, regulatory, and patient safety-related aspects of multicenter clinical trials (MCTs). MCTs study the effectiveness and safety of drugs/devices in humans. The PCC participates in more than 100 clinical trials, lasting from months to 15 years, with 2,500 clinical sites, 500-50,000 patients, using 250 drugs/devices. The PCC operates in a highly-regulated environment and thrives through visionary leadership, strategic planning, innovation, focus on customers, employee engagement, and systems approach. It implements the ADLI model into its total integrated performance excellence system (TIPES). The PCC benchmarks against contract research organizations (CROs), industry, and government and outperforms them on key measures of customer and employee satisfaction, engagement, and financial and market outcomes.
TIPES provides a solid foundation for PCC activities, creating opportunities for innovation and intelligent risk-taking in its pursuit of strategic objectives. PCC innovations resulted in improved web-based software systems for site inventory control, drug distribution, and patient randomization and treatment assignments.
Two new capabilities include the PCC’s biorepository for biospecimen storage and direct-to-patient dispensing; thereby expanding its offerings and providing the foundation for future growth. MBPEA examiners and VA visitors frequently note that the PCC does not operate like a government bureaucracy, but more closely resembles the private sector in its entrepreneurial approaches.
The proposed presentation describes use of multiple standards and tools to support improvement and high performance in the following key areas:
Even with its highly regulated processes, the PCC consistently outperforms a key benchmark of productivity, revenue per employee, when compared with top CROs. The PCC created a QMS model that directly address each of its key goods and services:
1. Pharmaceutical project management services for MCTs: ISO 21500; International Committee on Harmonization Guidelines for Good Clinical Practice
2. Drug manufacturing and primary packaging of drugs and devices: ISO 9001
3. Drug assays at its on-site biopharmaceutics/pharmacokinetics laboratory: ISO 9001; CAP accreditation
4. Randomization, treatment assignments, and inventory control systems design and programming: ISO 9001; ICH/GCP
5. Regulatory monitoring and auditing of clinical trial sites: ISO 9001; ICH/GCP
6. Design and operations of the new PCC Biorepository: ISO 20387
The PCC Leadership made an early strategic determination to validate its progress through voluntary examination by external agencies, such as ISO, CAP, NIST, Gallup, and Quantum. These examinations are in addition to mandatory audits by customers and multiple regulatory agencies (FDA, DEA, VA Office of Research Oversight). Our quality journey began in 1992; key milestones in this journey included:
1992: DEA registration
PCC success is demonstrated through re-certification to the ISO 9001 standard since 2003 and as recipient of the MBNQA in 2009. ISO 21500 has been integrated into the annual external ISO re-registration and surveillance audits. In 2018, the PCC began more formally integrating ISO 20387.