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Category: Blog Topics

Navigate clinical trial complexities with holistic, data-powered solutions

WCG’s Benchmarking, Analytics & Consulting solutions help organizations elevate clinical trial quality, compliance, and efficiency by supporting enterprise and strategic study planning activities. Strategic operations and organizational success start at the enterprise level and move into program and study level teams that implement strategies enabled by human and data intelligence. Accelerate your clinical research with […]

Examining Sustainability in Clinical Research

A New AQC Innovation Initiative – For more than a decade, the Avoca Quality Consortium (AQC) has emphasized the importance of driving change in the clinical trial execution process. This is predicated on our belief that organizations, working together, could realize change more effectively than organizations working in silos. Now we have the unique opportunity to […]

The Power of Collaboration: AQC Submits Comments to FDA for Consideration to Draft ICH E6(R3)

WCG’s Avoca Quality Consortium (AQC) provided comments to the FDA as part of the ICH E6(R3) Draft Guidance public consultation on behalf of our 200+ members. By leveraging the power of the consortium, we united cross-functional feedback, representative of all key stakeholders (Sponsors, CROs, Service Providers, and Sites). The revision to ICH GCP E6(R3) highlights […]

Understanding FDA’s Risk-Based Approach to Monitoring of Clinical Investigations

The FDA recently released “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry,” which provides updated recommendations on how sponsors of clinical trials should approach risk-based monitoring activities. The FDA’s guidance emphasizes a risk-based approach to monitoring with monitoring efforts focused on areas with the highest potential risk to patient […]

What is the Expectation for PI Oversight of Home Nursing Activities?

The FDA recently updated their Good Clinical Practice Inquiries and Responses 2017-2021. This Q&A publication is based on the questions submitted to the FDA via In response to multiple questions related to PI oversight of home nursing activities, the FDA responses have referenced the Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, […]

BIMO in Action: AQC Members Share Insights from Recent Inspection Experiences

The updates to the Bioresearch Monitoring (BIMO) program for Sponsors and Contract Research Organizations released in September 2021 shed light on FDA’s current thinking on important topics such as the selection and monitoring of clinical investigators and outsourced services. The BIMO program is a comprehensive FDA-wide program of on-site inspections and data audits designed to monitor […]

Incorporating QbD into the Provider Qualification Process

Quality is a primary consideration in the design, planning, conduct, analysis, and reporting of clinical studies and a necessary component of clinical development programs. [ICH E8 (R1)]. Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control and is based on […]

If It’s Not Documented, It Didn’t Happen – Importance of The Trial Master File

The Trial Master File (TMF/eTMF) is essential in telling the story of how your organization conducted your clinical trial activities, including how you ensured data integrity, patient safety, and compliance throughout the conduct of your trial. The TMF is a critical component of the trial process and is typically a primary area of focus for […]

The Gemba that is Clinical Research Sites

Providing site support and fostering best practice adoption – A foundational element for any Clinical Quality Management System (CQMS) is adequate policies and procedures that provide framework for quality and compliance in clinical trial conduct. Clinical trial sites are at the intersection of action and oftentimes inherit burden they may not be equipped or resourced […]

EU CTR Countdown – Don’t forget about Personal Data Protection

There are less than 3 months until the next phase of the EU CTR transition period. – From 31Jan2023, sponsors will be required to use CTIS for new clinical trial applications for studies in the European Union (EU) / European Economic Area (EEA) and from 31Jan2025, any clinical trials approved under the Clinical Trials Directive […]

FDA Issues New Draft Guidance on Diversity

Are you ready? – The FDA issued draft guidance on April 13, 2022, on Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials. They acknowledge that the lack of representation reflects, in part, a broader issue regarding differential access to healthcare as well as a mistrust of the […]

6 Questions Answered about Serious Breach Reporting

A Legal Requirement of the Clinical Trial Regulation (CTR) – What is a Serious Breach? A serious breach is ‘Any deviation of the approved protocol version or the clinical trial regulation that is likely to affect the safety, rights of trial participants and/or data reliability and robustness to a significant degree in a clinical trial’. […]

Business Continuity Planning for Investigative Sites

Do you have a business continuity plan? – Since March 2020, there has been a worldwide pandemic, fires in California, power outages in Texas and, most recently, war in Ukraine. In the latter case, sponsors will need to adjust the ways clinical trials are run in that region and deal with the impact of protocol […]

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 […]

What new types of collaboration groups will be offered in 2022?

During 2022, AQC will offer members the opportunity to participate in two new types of collaboration groups: Communities of Practice (CoP) and Metric Development Work Groups (MDWG). Members can participate in CoP groups that cover four areas:  Compliance/CAPA, Innovation Adoption (including AI/ML), Inspection Readiness/TMF, and QbD-RBQM-Quality Improvement (including centralized monitoring). Each Community of Practice – […]

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, […]

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 […]

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 […]

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 […]

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.