Consulting

Leading Practices in Clinical Outsourcing

Avoca has spent more than 15 years analyzing and driving the evolution of leading practices in clinical outsourcing. Having worked closely with sponsors and clinical service providers, gathered and authored more than 250 leading practices as part of The Avoca Quality Consortium, and built a team with decades of experience, Avoca offers a unique perspective on the state of clients’ outsourcing strategies today and how they can improve their approaches for tomorrow.

Outsourcing Models & Strategies

Avoca is the team sponsors turn to for help in deciding on outsourcing models and strategies. Whether a sponsor needs advice on determining the best outsourcing 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, Avoca’s mix of experience and customized research and consultation capabilities delivers data and insights to inform the process.

Oversight of Quality in Outsourced Trials

Avoca has helped many biotech and pharma organizations (including those in early stages) evaluate, develop, and implement “fit for purpose” best-in-class approaches to quality management and effective oversight in outsourced clinical trials. 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 and quality oversight practices that can be operationalized quickly and effectively by organizations. Avoca focuses on helping minimize micromanagement, strengthening relationships, proactively managing risk and developing efficient communication channels.

Quality Metrics

Sponsors are challenged to define how best to utilize quality metrics to optimize quality outcomes, measure aspects of quality that are meaningful across global matrixed organizations, and eliminate metrics that are not adding value. Avoca has developed a taxonomy and framework for quality metrics and has worked closely with leading pharmaceutical companies to determine and implement this taxonomy. Linking metrics to outcomes, the Avoca taxonomy can help your company organize and synthesize your quality-related measurements so that meaningful, actionable conclusions can be drawn to achieve improved project outcomes.

Risk Management

Avoca helps sponsors 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 to find and implement the mix of tools and processes that are fit for purpose for their businesses.