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Category: Risk Mitigation

Sites Offer Key Insights to Challenges of Risk-based Methodologies Associated with ICH E6 (R2)

In April 2018, The Avoca Group and The Association of Clinical Research Professionals (ACRP) co-sponsored a one-day program, the 2018 Quality Congress, in conjunction with the ACRP Annual Meeting (ACRP 2018). This full-day event offered participants – clinical research professionals from CROs, sponsor organizations, and sites – a unique view of the changing clinical trial […]

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 […]

ICH E6 (R2) is top of mind

1996 – A year on the calendar which was punctuated with a number of firsts – DVDs were launched, the first mammal was cloned, eBay debuted as one of the hottest companies and closer to our space, the adoption of ICH E6 GCP became a reality. Oh and may I add that Google did not […]

Firefighting – Heroism in need of change?

In the last six months, I’ve often heard the term “firefighters” used to describe teams that work on drug development.  Wikipedia defines a firefighter as, “a rescuer extensively trained in firefighting, primarily to extinguish hazardous fires that threaten property and civilian or natural populations, and to rescue people from dangerous situations.”  Wow!  Isn’t that a […]