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 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 […]
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, […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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.