Consulting & Research Services (DV)
With our decades of experience, WCG Avoca is a trusted partner to help maintain quality and compliance in a perpetually evolving clinical trials landscape. Our consultants contribute their deep experience in observing and influencing CRO and sponsor relationships to help our clients prosper in today’s fast-moving industry. Clients also benefit from the Avoca Quality Consortium’s (AQC) 500+ leading practices, tools, and templates as well as our industry research on trends and critical components for maintaining quality and compliance and strategic partnerships.
CASE STUDY: 27 DAYS TO INSPECTION READINESS
Leveraging Quality Expertise, WCG Avoca Provides Root Cause Analysis to Drive Process Improvement
CASE STUDY: NOT JUST A MOCK INSPECTION
With Storyboarding, WCG Avoca Gives Pharma Client the Insight & Tools for a Successful Regulatory Inspection
With our range of services, you can choose the right one(s) for your organization’s needs.
|GCP QUALITY AND COMPLIANCE|
|1. GCP Quality, Compliance, and Oversight: Biotech, pharma, and CRO organizations across the spectrum of size and tenure receive assistance with evaluating, developing, and implementing “fit for purpose” best-in-class approaches to quality management in clinical trial execution. Avoca’s consulting team works closely with key stakeholders to design and develop a quality management framework and set of standard processes for implementing quality management practices that can be operationalized quickly and effectively. As a result, organizations are able to quickly improve ICH E6 (R2) compliance, align with risk-based approaches, and ultimately, become inspection ready. Avoca’s services and proven processes range from quality and compliance at the site level to eTMF health assessments.|
|2. Quality Tolerance Limits: Sponsors and CROs are challenged to navigate the ICH E6 (R2) requirement for Quality Tolerance Limits (QTLs). Moreover, the use of varying terminology throughout the industry causes confusion about what is required. Avoca provides organization-level training on QTLs. In addition, we lead workshops that provide your teams with a key set of QTLs, thresholds, and actions needed to meet those thresholds.|
|3. Risk-based Approaches to GCP Quality: Avoca helps sponsors and CROs adopt proactive approaches and processes to identify, measure, and manage areas of risk. From the development of overarching risk identification and management frameworks, through to the review of technologies to organize, track, and visualize metrics, Avoca works with sponsors and CROs to find and implement the mix of tools and processes that are fit for purpose for their businesses.|
|4. Inspection Readiness: Our agile inspection preparation process is based on industry-leading practices and tools for inspection readiness and proactive, ongoing inspection preparedness. We offer mock inspection and audit services as well as remediation. Avoca’s services help to discover trial-related issues with sufficient time to effectively manage the inspection risk, provide your staff with the experience and tools they need for inspection preparedness, and avoid delayed product launches and internal remediation costs resulting from inspection findings.|
|DEVELOPMENT AND ENHANCEMENT OF CRO/SPONSOR PARTNERSHIPS: Based on our experience, we help establish best-in-class governance and strategic approaches to building and maintaining strong alliances. To maximize everyone’s satisfaction with the outcome, we start by gaining an understanding of both the sponsor and CRO’s perceptions and expectations.|
|DEVELOPMENT OF EXCEPTIONAL PERFORMANCE BY CRO STUDY TEAMS: CROs are supported in identifying factors that may be preventing study teams from high-level customer satisfaction. We develop best practices for operating within the sponsor/CRO relationship and work with the CRO study teams on relationship basics, developing best practices, and ensuring client satisfaction.|
|DEVELOPMENT OF PROGRAMS TO PROACTIVELY IDENTIFY AND MANAGE RISK: Avoca creates systems for understanding, in a detailed and quantitative fashion, the relationships between process quality, process adherence, and other risk-related variables and outcomes. CROs receive assistance with developing processes for managing desired outcomes in a rational, risk-sensitive manner.|
|LEADING PRACTICES IN CLINICAL SOURCING AND OVERSIGHT: Clients benefit from our 20+ years working closely with sponsors and clinical service providers and analyzing and driving the evolution of leading practices and tools in clinical outsourcing, including our Diligent® Qualification Platform. Through our experience, we offer a unique perspective on the current state of your outsourcing strategies and improvements in approaches for the future. Avoca’s consulting team works closely with key stakeholders to design and develop a set of standard processes for implementing quality oversight practices that can be operationalized quickly and effectively by organizations.|
|SOURCING MODELS & STRATEGIES: Sponsors turn to Avoca for help choosing sourcing models and strategies. Whether it’s advice on determining the best sourcing model, help in developing consistent practices for managing relationships with clinical service providers, or support with ensuring expectations are met on a particular outsourced trial, the process is informed by data and insight from Avoca’s mix of experience and customized consulting capabilities. Our Diligent® Qualification Platform was developed as a comprehensive mix of consulting services, tools, and technology to support vendor qualification decisions.|
Avoca delivers practical solutions to strengthen relationships and increase effective management of outsourced clinical trials between clinical service providers and their customers.
Sponsors (Pharma, Biotech, & Device Companies)
With our deep knowledge of the needs of sponsors and CROs, Avoca guides you through mitigating risk and optimizing opportunities from changes in regulatory guidance, innovation in technology, and the new clinical trials environment. We equip your team with the ideas, strategies, and processes it needs to thrive.