AQC-Pattern Accordion-Collapse Accordion-Expand Agenda-Map CROs Consulting Download Email Fax Filter-Check Filter-Remove LinkedIn Map-Pin Member-Login Pharma-Biotech-Devices Phone Summit-Registration Survey-Research The-Avoca-Group-Consulting-And-Research-Services-Horizontal The-Avoca-Group-Diligent-Prequalification-Platform-Horizontal The-Avoca-Group-Quality-Consortium-Horizontal Training avoca-logo-coloravoca-logo-graycheckconsulting_logo2 diligent_logo2 dots dotted-01 dotted down-arrow GroupCreated with Sketch. minus plus quality_logo2 right-arrow twitter

Category: Process Improvement

De-mystifying the Qualification of Decentralized Clinical Trials

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 […]

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

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 […]

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

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 […]

The Avoca Group Shares Inspection Experiences

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 […]

You Can’t Manage What You Don’t Measure

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, […]

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

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 […]

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

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 […]

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

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 […]

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

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 […]