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 […]
WCG’s Avoca Quality Consortium (AQC) provided comments to the FDA as part of the ICH E6(R3) Draft Guidance public consultation on behalf of our 200+ members.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 […]
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 […]
From January 31, 2023, use of CTIS for all initial clinical trial applications will be mandatory. CTIS was launched on January 31, 2022, starting the one-year transition time for all sponsors of clinical trials. During the first year, sponsors could choose whether to submit an initial clinical trial application in line with the Clinical Trial […]
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 gcpquestions@fda.hhs.gov. 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, […]
– Announcing FDA Keynote Speaker, Chrissy Cochran, PhD Chrissy J. Cochran, PhD, is Director of the Office of Bioresearch Monitoring Operations at the Food and Drug Administration (FDA) and is responsible for working with each of FDA’s product centers to manage the BIMO program. At the Summit, Dr. Cochran’s keynote address will highlight recent BIMO updates as well as […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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’. […]
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 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 […]
The WCG MCC QTL working group – a multistakeholder group of industry experts – met on 10 occasions over a 5-month period in 2021 to discuss challenges and best practice approaches for implementation of Quality Tolerance Limits (QTLs). The work culminated in a three-part article in Applied Clinical Trials. MCC founder Linda Sullivan and QTL […]
AQC’s Inspection Readiness | TMF Community of Practice Group Will Explore the Topic during June 14th meeting Timely TMF completeness is one of the goals of a well-functioning TMF process. Timeliness is relatively easy to measure – but how do you measure whether the TMF is complete? Join us on June 14, 2022 at 11:00 […]
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 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 […]
The MCC eCOA Process Metrics Work Group (now part of WCG AQC) – comprised of more than 200 individuals representing over 40 organizations – worked collaboratively from September 2020 to December 2021 to develop the assets contained in the eCOA Process Metrics Toolkit v3.0. The decision to review and update the eCOA metric toolkit was […]
The AQC Patient Diversity Metric Development Work Group was scheduled to discuss member feedback about the draft site diversity assessment scoring tool at a meeting on April 14. However, the agenda quickly changed when the FDA released a new draft guidance entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
Weaving decentralized trial (DCT) elements into clinical trial protocols can enhance quality and improve ROI. Unfortunately, as the results of the 2020 Avoca State of the Industry Survey suggest, many sponsors and CROs fail to recognize that value, and many harbor misconceptions about DCTs. That was the focus of a recent WCG Avoca webinar conduced […]
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: […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
When you browse through our recent blogs, you’ll notice risk-based inspections is a popular topic — from disparities between sponsor and provider expectations, as reported in our 2017 Avoca Industry Report, to a summary of inspection experiences. We continually hear that inspections are a major source of stress for companies involved in clinical trials. This […]
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 […]
The following is an excerpt from Longboat’s downloadable interview series “Expert Opinions: How the Clinical Trial Industry Needs to Evolve” featuring full interviews with high-impact leaders from the clinical research world. To access the full interview series, click here. Meet the Interviewee: Patty Leuchten, Founder and CEO, The Avoca Group Patty Leuchten started in the […]
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 […]
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 […]
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 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 […]
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 […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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.
Every time I hear this term being used, there is a part of me that freezes. The word “inspection” brings back the same sense of dread I used to have as a kid when I needed to prepare for an exam.
Brexit has been the talk of town following Britain’s recent decision to leave the European Union. Headlines are flying and the conversation is only strengthening around the impact this decision will have on industries of all kinds – including the pharma industry.
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.