Members can leverage the AQC’s ICH E6(R3) side-by-side comparison resources to support continuous quality compliance:

• INSP 26a- ICH E6(R2) and E6(R3) Comparison – updated!
• INSP 26b- ICH E6(R3) Draft to E6(R3) Final Comparison – new!

AQC members gathered for a meeting on Jan. 28 for an in-depth look at the key changes between the R3 draft and the R3 final version. Members can view the recording in the webinar archive section of the AQC Knowledge Center.

Jan. 28, 2025: AQC MEMBER-ONLY MEETING

Unlocking Insights – Overview of ICH E6(R3) Final Guidance Changes

VIEW RECORDING

An industry-wide webinar was held on Jan. 29, discussing the impact that these regulatory guidance changes have on clinical research organizations. View the webinar recording to learn the key updates to support successful adoption and get ahead of the curve of ICH E6(R3) implementation.

Jan. 29, 2025: INDUSTRY-WIDE WEBINAR

ICH E6(R3) is Here – What You Need to Know

VIEW RECORDING

Stay tuned for additional AQC resources and collaboration opportunities on this important topic to maintain compliance in your clinical trials.

Learn more about the AQC and get involved today

–

Published January 2025

The post Dive into ICH E6(R3) with AQC Strategies and Resources appeared first on Avoca, a WCG company.

Happy World Quality Week! Together with organizations around the world, we are celebrating this year’s theme, “Quality: from compliance to performance.” World Quality Week provides a chance to reflect on the role of quality and the importance of developing innovative and sustainable strategies to navigate complexity and face challenges in today’s dynamic landscape.

WCG’s Avoca Quality Consortium (AQC) brings together key stakeholders to enable industry collaboration and move the industry forward by elevating clinical trial quality, maintaining regulatory compliance, improving efficiency, and mitigating risk. Members have access to 1,500+ tools, templates, metrics, and more in the AQC Knowledge Center. They connect, learn, and stay current on industry topics through 50+ meetings annually. We acknowledge and celebrate the 200+ member organizations of the AQC for focusing on quality principles that drive beyond compliance to outstanding performance.

World Quality Week explores practical strategies and insights to help organizations harness the power of quality, which align to AQC resources and initiatives:

–

Take action with AQC resources focused on quality and compliance to navigate the complexities of clinical trials, together.

Contact us today to get involved in the AQC! ›

// ABOUT THE AQC //

The post The AQC Celebrates World Quality Week 2024: November 11-15 appeared first on Avoca, a WCG company.

With the upcoming AQC member resources, you will:

• Get inspection-ready from the start with mapping of AQC tools for each phase of the clinical trial lifecycle and see what is needed to kickstart your study.
• Build your quality management system (QMS) and streamline processes with mapping of AQC tools to the QMS.
• Gain access to a provider qualification (PQUAL) and oversight resource page, with a new leading practice for third-party subcontracted vendor qualification and oversight.
• Mitigate risk with a new Quality by Design/Risk-Based Quality Management (QbD/RBQM) overview with supporting resources and a new leading practice for risk-based approach for audits.
• Utilize new leading practices for effective issue management, including escalation pathways, issue log template, root cause analysis, and effectiveness checks.
• Focus on site quality with guidance on site qualification/oversight of decentralized clinical trial (DCT) providers, protocol evaluation, and electronic investigator site file (eISF) adoption.
• Elevate inspection readiness, boost innovation adoption, leverage AQC University courses, and plan for ICH E6 (R3) readiness and implementation.

AQC members can head over to the Knowledge Center to access the library of 1,500+ tools, templates, guidelines, metrics, and more to support and improve clinical trial processes. Stay tuned as great new additions are released.

Contact us today to get involved! ›

// ABOUT THE AQC //

The post AQC Member Resources: There’s Still More for 2024! appeared first on Avoca, a WCG company.

 Actionable steps for stakeholders include:

1. Emphasizing Critical Data and Processes:
   Identifying the critical to quality (CTQ) factors early can help drive key study activities such as monitoring strategy.
2. Early and Continuous Risk Assessments:
   Risk assessment focused on critical data and processes and shared across all stakeholders – including sites.
3. Preparing Sites for ICH E6 (R3) Changes:
   Sponsors and CROs should be prepared to assist sites in understanding and adapting to the new guidelines.
4. Promoting Cross-Industry Collaboration:
   Encouraging inclusive collaboration that integrates all perspectives for a more comprehensive approach to trial planning and execution.
5. Adopting Flexibility and Innovation:
   Openness to integrating new technologies and methodologies, ensuring they align with maintaining quality and compliance.

Learn more about becoming a member of the AQC with access to over 1,000 leading practices and metrics to stay up-to-date on industry guidances.
Contact Us

The post Leveraging ICH E6 (R3) to Drive Efficiency in the Clinical Trial Process appeared first on Avoca, a WCG company.

The industry metrics paint a troubling picture of the current state of clinical trials recruitment and retention. With 37% of study sites not meeting their enrollment targets and 80% of studies failing to meet theirs, the industry faces a dire need for more effective strategies (source: 2024 WCG Data Intelligence).

Part of the problem can be attributed to the limited participation of investigators in clinical research and significant issues related to site staffing. Moreover, recruitment and retention difficulties are recognized as significant detractors, closely tied to a site’s resourcing levels. This not only disrupts timelines but can also inflate the cost of clinical trials substantially.

–

Tackling the Site Identification and Feasibility Process

The process of site identification and feasibility is traditionally data-driven, relying heavily on existing relationships, in-house data, and historical experiences. Yet, a more nuanced approach is needed, incorporating a variety of data sources and reevaluating assumptions continually. For example, factors like the competitive landscape and protocol requirements must be considered, as they significantly impact a site’s recruitment and enrollment capabilities.

These activities are often treated as “one and done,” when, in reality, data from both internal and external sources constantly evolves. Feasibility, recruitment, and retention strategies must remain adaptable on an ongoing basis to maximize efficiency and study success.

–

The Gap in Trust and Communication

A significant gap exists between sites and sponsors regarding trust in feasibility results. Many sites believe sponsors trust their feasibility responses, whereas a vast majority of sponsors showcase skepticism. This disconnect underscores the necessity for a dynamic approach to site identification and recruitment planning, continuously adapting to changes and reevaluating initial assumptions based on real-world challenges and situations.

–

Rethinking Recruitment and Retention

Recruitment and retention should be viewed as a universal process with interconnected stages: identification, enrollment, retention, and documentation. Effective site selection, requires a deep understanding of a site’s capability to navigate through these stages, considering both internal contributions and the need for external referrals. Understanding the capacity of sites to manage external referrals and their geographical suitability for community outreach or provider networking is crucial.

–

Resetting Expectations and Approaches

The industry must acknowledge the active nature of clinical trials and the inevitable changes and disruptions that occur. Open and clear communication channels between sites and sponsors, mutual trust, and a shared focus on trial and participant priorities are essential for navigating these changes effectively. By fostering a collaborative environment free from blame shifting, the industry can adapt more effectively to challenges in recruitment and retention, ensuring trials are completed safely, efficiently, and with integrity.

In conclusion, addressing feasibility, recruitment, and retention challenges in clinical trials requires a multifaceted approach, emphasizing flexibility, collaboration, and continuous reevaluation. By bridging the gap between sites and sponsors and adopting more dynamic strategies, the industry can move towards more effective and efficient clinical trial processes and successful outcomes.

–

AUTHORS:

Crissy MacDonald, PhD
Vice President, Client Delivery
WCG

Seth Halvorson
General Manager, Site Solutions
WCG

–!

// DISCOVER MORE //

The post Understanding the Complexities of Feasibility and Recruitment Strategies appeared first on Avoca, a WCG company.

We are pleased to announce the launch of WCG’s Avoca Quality Consortium (AQC) medical device workstream!

Medical device guidance and regulations require manufacturers, or sponsors of device manufacturing, to adhere to rigorous processes to obtain regulatory approval and to maintain the safety and efficacy of products. This new AQC workstream enables collaboration and action needed to advance your clinical research, saving valuable time and resources with expert-developed tools, templates, and guidance.

The first set of leading practices is specific to design controls, which are essential to help ensure that products are safe, effective, and meet regulatory standards before they reach the market.

• Design Control Overview and Requirements
• Design and Development Plan and Template
• User Needs Document and Template
• Design Input Requirements and Traceability Matrix Template
• Design Output Requirements
• Design Verification and Validation
• Design Transfer Requirements and Template
• Design Reviews and Template
• Design History File and Template

–

The AQC’s leading practices for the design and development of medical devices, or combination products that have a device constituent, help to navigate specific medical device regulations, including those from the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Leading practices on risk management and management responsibilities are coming soon.

AQC members can view the new Medical Device Workstream page in the Knowledge Center for more information and links to resources.

Join the AQC now to leverage these critical documents and to be instrumental in shaping the future of the medical device library and workstream!

CONTACT US TO JOIN ››

// ABOUT THE AQC //

The post New AQC Medical Device Workstream appeared first on Avoca, a WCG company.

–

The 2024 Avoca Quality Consortium Summit will be held virtually on May 14-15, 2024.

Now in its 13th year, this industry-wide event will feature thought leaders and executive panels sharing experiences, insights, ideas, and actions to accomplish more with less time in clinical research.

–

Key Topics:

• Artificial Intelligence
• ICH E6 (R3) and Driving Quality
• Environmental Sustainability
• 2024 Avoca Industry Survey Results
• Risk-Based Provider Qualification and Oversight
• Patient Care and Advocacy
• Diversity, Equity, and Inclusion

–

Featured Speakers:

Andy Lee

Senior Vice President, Head of Global Clinical Trial Operations

Merck

–

Sue Weldon

CEO and Founder, Unite for HER

2021 AstraZeneca Catalyst for Care Award Winner

–

Wunmi Bakare

Patient and Advocacy Trailblazer

–

–

Learn more about this year’s full speaker line-up and agenda!

–

As a benefit of membership, Avoca Quality Consortium (AQC) member companies receive four complimentary passes and a discounted rate for additional attendees.

–

2024 Summit Sponsors:

The post Hear from Industry Leaders at the 2024 Avoca Quality Consortium Summit appeared first on Avoca, a WCG company.

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 a comprehensive suite of solutions that brings together integrated services to drive adjacent operational improvements and support industry needs across the study lifecycle.

Learn more and connect with an expert today!

The post Navigate clinical trial complexities with holistic, data-powered solutions appeared first on Avoca, a WCG company.

–

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 augment our innovation initiatives to increase sustainability in clinical trials.

The healthcare sector is responsible for 5.2%^[1] of greenhouse gas (GHG) emissions, which is approximately 2.7 billion metric tons of CO₂. This is more than double that of global aviation (2.5%)^[2] and equivalent to the emissions of 720 coal-fired power plants.^[3] Moreover, in clinical trials, we contribute up to 100 million tons of CO₂ to that total, or about 27 coal-fired power plants which equals 19.5 million US homes’ electricity usage for one year. The World Health Organization (WHO) has noted that to effectively protect the health of populations, health systems have the double responsibility of building climate-related health resilience and reducing their own carbon footprint.^[4] As scientists, we must seek solutions to this crisis. We must prioritize the search for opportunities that lead to a healthier, cleaner, and safer environment rather than continuing current “business as usual” practices.

Clinical trialists have a unique opportunity to lead medical innovation while also acting as environmental stewards. In this series of blogs focused on sustainability in clinical trials, we hope to provide a landscape for tactical and specific actions you can take in your role in clinical trials. Health systems consist of organizations whose primary intent is to promote, restore, or maintain health.^[5] Whether you are a CRC, CRA, or CEO, and whether you work in a small CRO or a large Pharma company, you can contribute to increasing sustainability in clinical research to protect the health of current and future generations.

Some AQC members’ solutions include:

• The PPD clinical research business of Thermo Fisher Scientific, is composting leftover food at a Phase I clinic that enrolls over 2,000 patients and screens 8,000 annually and its Phase II-IV clinic uses Uber Green (hybrids and EV) wherever available for patient transportation.
• Bayer has been donating surplus lab kits from clinical trials in the US to Kits4Life since 2020, thereby diverting unused kits from landfill and repurposing them for humanitarian aid and to educational institutions. Expanding its work with Kits4Life outside of the US is ongoing.
• Novartis has smartly consolidated medication shipments to clinical sites, reaching a reduction of almost 50% or –42,000 shipments in 2022. Additionally, they have introduced reusable shipper boxes across almost all cool-chain clinical site shipments and have put policies in place to avoid the medication frontloading of clinical sites prior recruitment once feasible.

Consider this an opportunity for you to find out what actions your company is taking related to sustainability as well as specifically thinking about how you and your team can contribute to running clinical trials with a reduced environmental impact.

AQC members can view a recording of the sustainability initiative kickoff meeting in the Knowledge Center.

We look forward to you joining us as we continue the conversation into 2024.

–

Learn more about becoming a member of the AQC to get involved!
Contact Us

–

–

Authors:

Jürgen Wieland

Development Environmental Sustainability Lead; Novartis

–

Carly Santer

Impact Officer; Bayer UK & Ireland

–

Michael J. Cohen

Senior Director, Environmental Sustainability, Digital and Decentralized Solutions; PPD

–

–

References:

[1] Romanello, M, et al., “The 2022 report of the Lancet Countdown on health and climate change: health at the mercy of fossil fuels”. Vol 400, Issue 10363, 5-11. Nov 2022.

[2] Hannah Ritchie, “Climate change and flying: what share of global CO2 emissions come from aviation?” 2020, Published online at OurWorldInData.org, https://ourworldindata.org/co2-emissions-from-aviation.

[3] US EPA, “Greenhouse Gas Equivalency Calculator,” www.epa.gov/energy/greenhouse-gas-equivalencies-calculator#results.

[4] WHO, “Operational framework for building climate resilient and low carbon health systems,” 9789240081888-eng.pdf (who.int).

[5] Sustainable Markets Initiative, “The Digital Solution for Sustainability in Clinical Research,” https://a.storyblok.com/f/109506/x/42119be232/smi-hstf-digital-health-whitepaper.pdf.

–

Published: December 2023

The post Examining Sustainability in Clinical Research appeared first on Avoca, a WCG company.

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 importance of proportionality and risk-based approaches with focus on quality while encouraging continued innovation; this is a significant update to the conduct of clinical trials for the industry.

In addition to submitting comments on areas that may warrant additional clarity, we have also highlighted training opportunities that may be critical to the successful implementation of this guidance. We anticipate that robust training will strengthen understanding for individual stakeholders as well as ensure consistency across all clinical trial stakeholders.

The Power of Collaboration – thank you to all our members who contributed feedback!

See the comment submission ››

–

Learn more about becoming a member of the AQC and access over 1,000 leading practices and metrics to stay up-to-date on industry guidances.
Contact Us

–

–

Published: September 2023

The post The Power of Collaboration: AQC Submits Comments to FDA for Consideration to Draft ICH E6(R3) appeared first on Avoca, a WCG company.