Access WCG Avoca’s recent webinar recordings below:
Implementing ICH E8 R1 Recommendations Increases Site and Participant Relationship Scoring Measures ›
June 8, 2023
WCG Avoca and CenterWatch 2022 industry research shines a light on the importance of site and participant relationships for sustainability of the clinical research patient and investigator pools. Industry and regulatory focus on quality by design requires cross-functional feedback on study design. Similarly, patient and site centricity are critical for a robust clinical trial industry. However, most sponsor and provider organizations base their study designs on feedback from investigators and participants who are familiar with the clinical trial industry. In order to expand the patient pool for clinical research, Sponsors must develop protocols that meet the needs of research-naïve participants and investigators.
January 18, 2023
There are an increasing number of clinical trials being conducted which leads to an increasing need for patients and investigative site staff to participate. Early research has shown that decentralized clinical trials (DCTs) can be beneficial for patients. The hypothesis was that implementing DCTs would also benefit sites; however, experience has shown that DCTs can present some challenges for sites.
June 28, 2022
ICH E8 R1 was made effective on April 14, 2022. Per ICH.org, the revision proposes to (1) identify a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to protect human subjects; (2) address a broader range of trial designs and data sources; (3) provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies.
2021 WCG Avoca Industry Survey Data Report Out: Diversity in Clinical Research Execution and Participation ›
June 16, 2022
The events of the last two years created an urgent and nonnegotiable imperative to increase diversity in clinical research: diversity both in how such studies are executed, and in the types of patients recruited for participation. As we move forward, industry leaders must synthesize this experience and incorporate its lessons into the clinical operations culture — deciding how much executional diversity to retain, determining how we can maintain diversity in trial participants, and marshaling the motivation of clinical researchers to sustain the effort required for both.
April 6, 2022
ICH E8 (R1) makes it clear that having an effective quality culture is imperative. To explore needs, challenges, and solutions, WCG Avoca addresses leading practice concepts, approaches, and tools for implementing an effective global quality culture and Clinical Quality Management System (CQMS).
The updated BIMO guide’s expectations related to Sponsor Organization’s Quality Management Systems ›
March 9, 2022
Quality Management Systems (QMS) has been called out as a regulatory expectation in ICH E6 R2 and the ICH E6 R3 business plan indicates that this is a key component of high-quality clinical trial execution. The recent BIMO guide that was released also indicates that inspectors will be further scrutinizing an organization’s policies, procedures, risk management and will focus on whether or not the Sponsors are showing continuous improvement of their quality management system. The Avoca Quality Consortium 12 component quality management framework is a guideline for Sponsors to evaluate their QMS and determine areas of weakness as it relates to regulatory and compliance as well as industry-leading practice. Ensuring a quality management system is in place prior to conducting clinical trial activities that are likely to be inspected by regulatory agencies yields more successful inspection results.
December 16, 2021
In anticipation of WCG AQC bringing together the WCG Metrics Champion Consortium (MCC) and AQC, we are pleased to present industry experts Linda Sullivan and Keith Dorricott for a discussion about defining metrics that answer key performance questions and empowering metric users to use metric results to streamline processes, improve quality and build relationships.
September 22, 2021
In an increasingly competitive market, how do Sponsor organizations proactively reduce site burden to create more effective and positive relationships with focus on issues that matter?
The age-old constraint for clinical trial execution has been the ability to find patients. In an increasingly competitive market, Sponsor organizations are fighting for time from already resource constrained sites to perform patient recruitment, patient engagement activities as well as traditional patient care, data entry, and administrative tasks. But what is your organization doing to ensure that sites are spending their time on meaningful and value-add activities?
August 31, 2021
As the complexity of clinical trials continues to increase, so does the importance of CROs to the pharmaceutical industry. Outsourcing allows pharmaceutical companies to utilize on-demand services, improving operational efficiencies by accessing therapeutic expertise and geographic reach. This reflects a sharper focus on core competencies and a shift to allow CROs to manage and conduct clinical trials.
ICH-based regulations have traditionally led to more overhead in the form of processes, headcounts and systems. These regulations concerning oversight cascade to all stakeholders further increasing complexity and associated costs.
Register for this webinar to hear about the forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines, which renew the focus on efficiencies in conducting clinical trials and provide tools to do so – significantly impacting oversight.
June 17, 2021
How do we finish what COVID started?
The COVID pandemic shined a light on two areas of historical weakness in the clinical research industry – a slowness to adopt technology and a lack of proactive planning to ensure clinical trial subject diversity – but also exposed the industry’s potential for tremendous achievements in each of these areas. In this webinar, the first to highlight the 2020 Avoca Industry Research involving representatives from over 150 companies, you will learn about how the events of 2020 accelerated operational and study design innovations within clinical development, how respondents perceived various aspects of clinical trial quality, patient diversity, and efficiency to have been impacted, what drivers and impediments arose, and whether respondents anticipated a “snap back” to pre-innovation approaches and perceptions, or an acceleration of innovation, post-Covid-19. We will also explore respondents’ perceptions of the performance of their own companies, and the industry as a whole, with respect to diversity in clinical trial participation, and with respect to true preparedness for deployment of clinical research innovations. Finally, we will discuss how experiences and perceptions vary across companies within the industry, with a focus on what this tells us about leading practices for success in these areas.
May 26, 2021
In Clinical Trials, Quality is often synonymous with study success.
Reducing the likelihood of errors increases the safety of study participants and the credibility of results. So how can today’s study teams harness innovative decentralized clinical trial (DCT) technologies to improve quality? It all starts with the right protocol.
In this webinar, Medable and WCG Avoca share results from the 2020 Avoca State of the Industry Survey and real clinical trial case studies from Medable. In doing so, attendees will understand the common challenges faced by study teams, and how weaving DCT strategies into their protocols can help overcome them, improving quality across an array of activities and study health measures:
- Enhanced Patient Safety Through Remote Monitoring
- Increased Protocol Compliance and Study Retention
- Increased Patient Access and Diversity
- Denser, More Actionable Sets of Study Data
Are you anticipating submitting for market authorization approval and do you know the associated risks? To be compliant with ICH E6 (R2), ICH E8 (R1), and other regulations assessed by auditors and inspectors, risk-based quality management for clinical trials is required. This is even more imperative with the quickly changing trial landscape brought on by COVID-19.
Join this one-hour webinar to evaluate your QMS and ensure you have a solid, risk-based Quality Management System that is compliant with the latest industry regulations during and following the COVID-19 period. We will address the changes required for privacy, quality management, and for validating trials and how to best adapt to overcome the challenges brought on by COVID-19. These include effective approaches for remote source data review and verification (rSDR/rSDV), use of technology, documenting protocol and ICF deviations or amendments/adjustments, and effective utilization of eTMF to withstand intense regulatory inspections, including newer requirements instituted by ICH E8 (R1) and ICH E6 (R2); even anticipated requirements for ICH E6 (R3).
March 30, 2021
ICH E6 (R3) is coming at a time when life science organizations still are struggling to adopt ICH E6 (R2). But should organizations wait until these guidelines are ratified to realize the intended benefits?
The recently released ICH E8 (R1) draft, a precursor to this new guidance provides the answer, specifically calling for establishing a culture that supports critical thinking and open dialogue about quality that goes beyond sole reliance on tools and checklists.
Applying critical thinking during study startup is pivotal to improving study conduct overall. Proactive planning is essential to identifying what is needed to mitigate risk, ensure regulatory compliance and audit-readiness, and in order to avoid serious budget and timeline overages. These issues can derail a study resulting in costly rescue interventions, often due to issues that are preventable.
May 5, 2020
This webinar discussed the benefits of proactive preparation for ICH E6(R3) with an emphasis on collaboration opportunities within innovation alliances, such as technology and capabilities into a diversifying set of options for decentralized and virtual trials.
The Final Concept Paper for ICH E6(R3), dated 17 November 2019, states, “The action proposed is a full rewrite and reorganization of the ICH E6(R2) Guideline….and will include addressing the application of GCP principles to the increasingly diverse trial types and the data sources being employed to support regulatory and healthcare-related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.”
February 18, 2020
The clinical trials industry is filled with a multitude of acronyms. Deciphering them, making sense of regulations, and understanding semantics – in an industry that often does not speak precisely – can be a challenge.
ICH E8 (R1) was released for comment from May through October 2019. This revision to general considerations for clinical trials was triggered by ICH E6 (R2) with the intent to provide updated guidance that is appropriate and flexible to address the increasing diversity in the design and data sources employed in today’s clinical trials while preserving foundational principles supporting human subject protection and data quality.
This webinar focuses on the Quality Tolerance Limit (QTL) requirements of ICH E6 (R2) while addressing the intersect of Section 3 of ICH E8 (R1), where specific focus is given to proactive quality-by-design in clinical trials, including identifying and managing critical-to-quality factors (CTQs).
Do You Have an Effective Oversight Plan of Your CRO-Vendor? How Are You Measuring It? ICH E6 R2 Requirements for Vendor Oversight ›
January 29, 2020
Sponsor Responsibilities for Quality Management (Section 5.0 of ICH E6 (R2)) requires that Sponsors oversee trial-related duties and functions, including those that are subcontracted by CROs (5.2.2). Quality assurance has changed from assurance of conformity to the assurance that process performance and quality are managed over the (relationship and) trial life cycle. Focusing monitoring and oversight resources on risks that matter has become an obligation.