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Category: Process Improvement

Is Your Organization Prepared for Risk-Based Inspections? Depends on Who You Ask.

With the adoption of ICH E6 (R2), risk-based quality management for clinical trials has become an expectation, and inspectors are starting to use these guidelines in their audits. However, The Avoca Group’s research, documented in the 2017 Avoca Industry Report, indicates that sponsors and providers both have work to do to be truly prepared for […]

Recognizing and Addressing Inefficiencies in Vendor Qualification – One Step at a Time

With the continued commitment to clinical outsourcing by sponsors to achieve their goals comes a need to improve our working relationships. This has become particularly important due to the requirement for sponsors to improve provider oversight to comply with ICH E6 (R2). To begin, we can focus on the vendor selection and qualification process, which […]

Technology and Risk: How Systems and Software Are Impacting ICH E6 (R2)

Sponsors and providers alike in the pharmaceutical industry are being confronted with the need to leverage technology to meet the demands of the risk-based ICH E6 (R2) guidelines. The reason is simple: the guidelines have shifted the focus of inspections into new territory, and existing legacy systems and disparate data sources can’t cope with the […]

Proactive Planning is Key to Process and Quality Improvements in Clinical Trials

Written and submitted by AQC Member, Craig Morgan, Head of Marketing, goBalto™   If you fail to plan, you are planning to fail. These words ring true when it comes to study startup, a notorious bottleneck in clinical trials. With research showing a continually stagnating timeframe for conducting clinical trials and a trend toward improving […]

Sponsor and Provider: Two Very Different Perspectives on Risk-based Provider Oversight

The advent of ICH E6 (R2), with its risk-based approaches to provider oversight, has not been one of the smoother transitions in the industry. The Avoca Group’s research, documented in the 2017 Avoca Industry Report, illuminates significant concerns about this addendum by sponsors and providers alike. These concerns, however, serve to point the way toward […]

One challenge, two industries, a similar solution!

As a parent who recently partnered with her child on the college applications process, I had a moment of insight, relief and gratitude. Thank goodness for the Common App. Before the mid-90s, students had to fill out individual applications for each college, write essays for each application, answer the same questions about classes taken and accomplishments rewarded about 10 times over. Just thinking about the time and effort saved, not to mention the better quality of the applications made me feel very grateful for the Common App.