Avoca Blog

A space where we share our musings and encourage dialogue on topics that intrigue, perplex, and create a world of possibilities.

FDA Issues New Draft Guidance on Diversity
Post in Process Improvement

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 – The FDA issued draft guidance on April 13, 2022, on Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials.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 […]

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Avoca Blog

6 Questions Answered about Serious Breach Reporting

Business Continuity Planning for Investigative Sites

AQC Patient Diversity Work Group Members Reviewing Key Site Attributes to Include in Site Assessment Scoring Tool

AQC QbD-RBQM-Quality Improvement CoP Group Exploring Current QTL Practices and Use of KRIs

Is it possible to measure TMF completeness accurately? It may be worse than you think!

QTL Working Group Publishes 3-part Series

Inspection Readiness Storyboarding – Provides a Strong Framework for Alignment

eCOA Process Metrics v3.0 will be released at the Metric Demo and Q&A Meeting on April 27

Patient Diversity Work Group Pauses Metric Discussions to Discuss DEPICT Legislation and the FDA’s Diversity Plan

Metric Demo and Q&A Monthly Meeting Series

Community of Practice Group AQC Meetings

Approaches to selecting sites capable of enrolling under-represented participants in clinical trials.

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

Ask the Experts: ICH E6 R2 Requirements

Ask the Experts: Vendor Oversight

Ask the Experts: Risk-Based Monitoring

Ask the Experts: KRI Thresholds

Achieve More Diverse Trials with the AQC Site Diversity Workbook

Stay in Compliance and Save Time with the AQC Risk-Based Monitoring Plan Template

Fear of Failure May Inhibit Innovation, Lack of Awareness May Inhibit Diversity Efforts

It’s a Benefit, Not a Risk: Understanding and Countering Misperceptions About Decentralized Trials

Implementing Risk-Based Quality Management

The Power of Metrics in Clinical Trial Programs

Leading Practices for Provider Qualification

Inspection Readiness: How Mock Inspections are Part of a Solid QMS

ICH E6 (R2) Requirements for Vendor Oversight

Ensuring Compliance with Standard Operating Procedures (SOPs)

Opportunities and Risks Abound in Transition to Patient-Centric Research Models

In a World of Digital Adoption, How Do We Overcome the Resistance to Technology in Drug Development?

Proactive Risk-Based Preparation for Inspections Moves Your Organization to a State of Readiness

De-mystifying the Qualification of Decentralized Clinical Trials

Bringing the Quality and Compliance Perspective to Clinical Trials; a Look at the Industry with Patty Leuchten

What Are Quality Tolerance Limits (QTLs) and Why Are They Important?

Inspection Readiness: What is it and how do we get there?

Inspection Preparation With a Risk-Based Approach Consistent with ICH E6 (R2) Requirements

The Avoca Group Shares Inspection Experiences

Sites Offer Key Insights to Challenges of Risk-based Methodologies Associated with ICH E6 (R2)

You Can’t Manage What You Don’t Measure

Is Your Organization Prepared for Risk-Based Inspections? Depends on Who You Ask.

Recognizing and Addressing Inefficiencies in Vendor Qualification – One Step at a Time

Technology and Risk: How Systems and Software Are Impacting ICH E6 (R2)

Are Risk-based Approaches to Assessing and Managing Clinical Trials Sustainable?

Risk-Based Quality Management: Working It Out in the Trenches

Proactive Planning is Key to Process and Quality Improvements in Clinical Trials

Sponsor and Provider: Two Very Different Perspectives on Risk-based Provider Oversight

Patient perspectives on clinical trial participation and engagement

ICH E6 (R2) is top of mind

Firefighting – Heroism in need of change?

One challenge, two industries, a similar solution!

Can we move to a world where the word “inspection” does not trigger anxiety?

Brexit – Will it or won’t it change the way drug development is done in Europe?

Is creativity needed in the search of qualified CRAs?