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Tag: ICH E6(R2)

Inspection Preparation With a Risk-Based Approach Consistent with ICH E6 (R2) Requirements

The Avoca Group recently conducted a webinar about strategies for inspections using a risk-based approach as outlined in ICH E6 (R2). Audience members submitted many questions focused on the Trial Master File (TMF). This blog summarizes the most frequent inquiries from the webinar related to TMFs and offers our responses.   TMF Regulatory Requirements Because […]

TEST RELATED Sponsor and Provider…

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 […]

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 […]

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 […]

Are Risk-based Approaches to Assessing and Managing Clinical Trials Sustainable?

So far, the implementation of ICH E6 (R2), with its risk-based approaches to assessing and managing clinical trials, has been a bumpy ride. Results have not been outstanding, to say the least. In fact, sponsors and providers are within their rights to wonder if the new paradigm is sustainable in the long-term. But the problem […]

Risk-Based Quality Management: Working It Out in the Trenches

With the adoption of ICH E6 (R2), risk-based quality management for clinical trials has become an expectation across the pharmaceutical industry. So, how is it working out in the trenches of daily operations? The Avoca Group’s research, documented in the 2017 Avoca Industry Report, indicates that, while there are concerns, there is also potential for […]

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 […]

TEST 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 […]

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 […]