Avoca Blog

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

Implementing Risk-Based Quality Management
Post in Process Improvement

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: […]

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The Power of Metrics in Clinical Trial Programs

Posted in Process Improvement

Leading Practices for Provider Qualification

Posted in Process Improvement

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

Posted in Process Improvement

ICH E6 (R2) Requirements for Vendor Oversight

Posted in Process Improvement

Ensuring Compliance with Standard Operating Procedures (SOPs)

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Process Improvement

De-mystifying the Qualification of Decentralized Clinical Trials

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Risk Mitigation

The Avoca Group Shares Inspection Experiences

Posted in Process Improvement

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

Posted in Risk Mitigation

You Can’t Manage What You Don’t Measure

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Process Improvement

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

Posted in Risk Mitigation

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

Posted in Risk Mitigation

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

Posted in Process Improvement

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

Posted in Process Improvement

Patient perspectives on clinical trial participation and engagement

Posted in Patient Engagement

ICH E6 (R2) is top of mind

Posted in Regulatory, Risk Mitigation

Firefighting – Heroism in need of change?

Posted in Risk Mitigation

One challenge, two industries, a similar solution!

Posted in Process Improvement

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

Posted in Regulatory

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

Posted in Regulatory

Is creativity needed in the search of qualified CRAs?

Posted in People Management