Q: Since we implemented Risk-Based Monitoring we have been trying to monitor the process to determine how well it is working. We have developed metrics such as whether alerts from Centralized Monitoring are closed on time but are uncertain what to use as a target. How are other organizations approaching this? (Metric Insights, Jan. 2021) A: With […]
AQC Tool Highlight: Site Diversity Workbook The FDA and other Regulatory Agencies have established guidelines on enhancing the Diversity of Clinical Trial Populations for the Industry. Despite promoting enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug (if approved), challenges to diversified participation in clinical […]
AQC Tool Highlight: Risk-Based Monitoring Plan Template The FDA has established Risk-Based Monitoring guidance* which encourages sponsors to tailor monitoring plans to the needs of the investigation, describes factors to consider in developing a monitoring plan, and provides examples of monitoring methods and techniques. The FDA believes risk-based monitoring is an important tool to allow […]
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 of […]
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 […]
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 […]
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 […]
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 […]
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 […]