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Author: Jenn Loaiza

AQC Patient Diversity Work Group Members Reviewing Key Site Attributes to Include in Site Assessment Scoring Tool

AQC Patient Diversity Metric Development Work Group members met on 9 June 2022 to discuss the challenges organizations encounter developing patient diversity plans, identifying sites able to recruit under-represented patient populations (URPP) and tracking recruitment success. They reviewed how current AQC tools and the new proposed site assessment tool will help organizations address some of […]

QTL Working Group Publishes 3-part Series

In late 2020, WCG MCC members decided to develop guidance on quality tolerance limits (QTLs) – regarding metrics, implementation and use – by channeling experiences from across the industry. A working group of 20 individuals (representing 16 organizations) met virtually during 2021 to discuss the challenges and develop a leading practice approach to be shared […]

Inspection Readiness Storyboarding – Provides a Strong Framework for Alignment

Inspection Readiness Storyboards, when created properly, are powerful tools for summarizing an organization’s process during a clinical trial, by condensing the study’s story into easily shared high level messages or snapshots that identify key information and related decisions made during the trial. Storyboards can provide a strong framework for clear messaging that is easily communicated […]

Metric Demo and Q&A Monthly Meeting Series

Throughout 2022, the AQC will host a monthly meeting for Members to learn about metric toolkits available in the AQC Knowledge Center. During the 1-hour virtual meeting, metric experts will provide an overview of a selected toolkit, show how to use the toolkit metric selection tools, and answer audience questions. The metric toolkits scheduled for […]

Community of Practice Group AQC Meetings

The highly rated Community of Practice (CoP) groups meet as part of the AQC member program, sharing ideas and practical approaches to address challenges unique to each community. Members determine priority topics and share knowledge through case study presentations, panel sessions, and facilitated brainstorming sessions. The following three CoPs will meet in 2022 and discuss […]

Ask the Experts: ICH E6 R2 Requirements

Q: ICH E6 R2 requires us to focus particularly on critical data and processes in quality risk management. Do you have any metrics that help assess whether our efforts are focused in this way? (Metric Insights Aug. 2021)  A: This was a topic of discussion in the Centralized & Site Monitoring Process Metrics Work Group meetings earlier […]

Ask the Experts: Vendor Oversight

Q: One of our vendor oversight metrics measures whether our CRO has billed us for the amount that we expect by quarter. We are finding that this sometimes green even though we know there are problems with costs not matching the work that should have been completed. Or it might be red but when we drill […]

Ask the Experts: Risk-Based Monitoring

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 […]

Ask the Experts: KRI Thresholds

Q: We are accelerating implementation of our Centralized Monitoring program due to the COVID-19 pandemic. We’ve started with a small number of Key Risk Indicators (KRIs) including AEs/patient. We have upper and lower threshold limits, so we can look for outlier sites – those that are over- or under-reporting relative to others. But what we’ve […]

Achieve More Diverse Trials with the AQC Site Diversity Workbook

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 […]

Stay in Compliance and Save Time with the AQC Risk-Based Monitoring Plan Template

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 […]

Fear of Failure May Inhibit Innovation, Lack of Awareness May Inhibit Diversity Efforts

Sponsors and CROs aspire to be more innovative and achieve greater diversity, but only a few have crossed the bridge from aspiration to practice; one reason may be a fear of failure. That’s just one of the take-aways of the 2020 Avoca Industry Report, which explored respondents’ perceptions surrounding innovation and diversity in clinical trials. […]

Implementing Risk-Based Quality Management

Avoca Insights: A video series of Subject Matter Expert industry observations See Helen Harlow, Consultant of The Avoca Group, discuss the implementation of Risk-Based Quality Management (RBQM) and the need for better techniques and tools to proactively manage all aspects of risk in clinical trials in order to help move the industry forward. AQC Members: […]

The Power of Metrics in Clinical Trial Programs

Avoca Insights: A video series of Subject Matter Expert industry observations See Denise Calaprice, PhD, Senior Consultant of The Avoca Group, discuss how the power of metrics is part of what makes coming up with a system and related processes so difficult. Learn about the importance of developing effective, efficient, and comprehensive clinical trial measurement […]

Leading Practices for Provider Qualification

Avoca Insights: A video series of Subject Matter Expert industry observations See Janis Hall, Senior Consultant of The Avoca Group, discuss how health authorities are increasingly interested in the identification, selection, and oversight of Clinical Service Providers that are used by Sponsors and CROs in the conduct of clinical trials, and how to be prepared […]

Inspection Readiness: How Mock Inspections are Part of a Solid QMS

Avoca Insights: A video series of Subject Matter Expert industry observations See Jay Turpen, Senior Consultant of The Avoca Group, discuss the importance of inspection preparedness and how mock inspections assist organizations in being prepared for regulatory authority inspection. Learn more about Avoca’s Inspection Readiness Consulting Services › AQC Members: Access the Knowledge Center’s Inspection […]

ICH E6 (R2) Requirements for Vendor Oversight

Do you have an effective oversight plan? How are you measuring it?   ICH E6 (R1) was modernized to keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology. It took two decades for that change to be implemented (1996 to 2016) but now the pace of change […]

Ensuring Compliance with Standard Operating Procedures (SOPs)

Written and submitted by Craig Morgan, Head of Marketing, Study Startup, Oracle Health Sciences – an AQC Member company.   Standard Operating Procedures (SOPs) rarely grab the spotlight like transformational technologies or newer strategies, such as risk-based monitoring, quality by design, or decentralized clinical trials. But SOPs deserve some recognition. With their coveted goal of […]

Opportunities and Risks Abound in Transition to Patient-Centric Research Models

Written and submitted by Craig Morgan, Head of Marketing, Study Startup, Oracle Health Sciences – an AQC Member company.   Very little has changed in traditional clinical trials since their inception to ensure the efficacy and safety of drugs in human subjects. Borne out of academic medical centers they have expanded to include community hospitals, […]

In a World of Digital Adoption, How Do We Overcome the Resistance to Technology in Drug Development?

Despite the increasing use of digital devices worldwide, only 14-31% of sponsors and providers reported using mobile health technologies and virtualized approaches to clinical trials, including telehealth, in our recent survey (The 2018 Industry Research Report: Perspectives on Clinical Innovation & Technology). Although at least the same proportion of respondents, particularly providers, indicated plans for […]

De-mystifying the Qualification of Decentralized Clinical Trials

Decentralized clinical trials (DCTs) offer a more patient-centric approach, reflecting a transformational philosophy for the conduct of clinical trials in which fewer clinic visits are required and patient and caregiver burden is reduced. To achieve this, DCTs deploy a wide range of digital technologies to collect safety and efficacy data from study participants, normally from […]

What Are Quality Tolerance Limits (QTLs) and Why Are They Important?

In accordance with ICH E6 (R2), the expectations for Quality Tolerance Limits (QTLs) when conducting clinical trials have generated a buzz in the industry. QTLs have historically been required for Good Manufacturing Practice (GMP) activities, inferring limits by which significant actions must be taken to ensure the manufactured product achieves quality and usability limits. With […]

Inspection Readiness: What is it and how do we get there?

This blog was submitted by Ashley Argiras, Associate Director, Quality Assurance, Vertex, and is a summary of a roundtable discussion held at the 7th Annual Avoca Quality Consortium Fall Member Meeting. Challenges in Implementing Successful Inspection Readiness Programs Senior leaders within organizations generally identify the need for inspection readiness (IR) programs. A critical challenge to […]

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 of […]

The Avoca Group Shares Inspection Experiences

The Medicines & Healthcare products Regulatory Agency (MHRA) in the U.K. and the U.S. Food and Drug Administration (FDA) are working more closely together in new ways to synchronize—and strengthen—each other’s regulatory inspections, according to an anecdotal data research report on trends in practices of these and similar regulatory authorities around the world from The […]

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 […]

You Can’t Manage What You Don’t Measure

Risk is our constant companion. As clinical trials grow in complexity, so do risk-based challenges associated with bringing new therapies to market. The process of initiating clinical trials, collectively known as study startup, is cumbersome, challenging and fraught with delays. Study startup has an impact on patient recruitment, trial duration and associated costs, and unfortunately, […]

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 […]

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 study […]

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 […]

Patient perspectives on clinical trial participation and engagement

Everyone is talking about patient engagement.  The informed, empowered patients of today want to play an active role in the selection and management of their medical care and are not afraid to demand it.  To understand this mindset better, we surveyed nearly 600 patients who shared their opinions on clinical trial participation: how they feel […]

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 […]

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.

Is creativity needed in the search of qualified CRAs?

I can’t find enough qualified CRA’s”, “The shortage of CRA’s is a real problem”, “We need to look at different ways of attracting millennials” …. these were a smattering of comments I heard expressed at the Avoca Quality Consortium Summits earlier this summer.