How an Oversight Capability Maturity Model and Automation Drive Speed and Quality of Clinical Trials
Interim findings from the 2017 Avoca Industry Research on Risk in Clinical Trials indicate that only 33% of sponsors are satisfied with their providers’ (CROs/FSPs) level of expertise and experience in applying risk-based approaches to quality management overall.
For this webinar, Comprehend has partnered with Avoca to share industry best practice for oversight blended with their best in class clinical intelligence applications.
Janis Hall, Senior Consultant at The Avoca Group will detail the challenges and opportunities sponsors face in providing effective oversight and where/how they can progress their organizational capabilities for oversight in order to optimize clinical trial performance. Avoca developed an Oversight Capability Maturity Model through its Avoca Quality Consortium (AQC). This tool is used to assess an organization’s capability to accomplish a defined set of critical oversight activities. Avoca will outline ten leading practice dimensions of the model that are vital for effective oversight. This AQC Oversight Capability Maturity Model is designed to link users to internal (AQC) and external leading practice guides and tools that can be leveraged to advance oversight capabilities and enable compliance to ICH E6 (R2).
Julie Peacock of Comprehend will follow with a real-world case study of how a sponsor applied technology to manage the Sponsor-CRO relationship, including the automation of quality agreements and oversight plans. This sponsor now monitors issues in real-time and executes against fact-based metrics. Comprehend will provide a live demonstration of how this customer is able to:
- Create, monitor and manage quality agreements and oversight plans
- Proactively identify and mitigate risk
- Manage site performance
- Empower teams through collaboration and workflow
With these capabilities the end result was improvement in milestone achievement, increased productivity and compliance with ICH E6(R2).
Julie Peacock, Client Services, Comprehend
Closely aligned with customers and the sales organization, Julie focuses on enabling prospects and customers on Comprehend’s Clinical Intelligence solutions. She manages go to market strategy, sales enablement, and product marketing.
Prior to Comprehend, Julie spent 18 years at Oracle Corporation in the enterprise application space where she managed strategy, field enablement and launch activities for a series of BtoB solutions. Julie holds a bachelor’s degree in Marketing from Auburn University.
Janis Hall, Senior Consultant, The Avoca Group
Janis Hall has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) she was responsible for R&D sourcing, contracting and supplier alliance management. As the primary point of contact to health authorities for inspection readiness for strategic sourcing, she developed and successfully implemented an end-to-end process for inspection readiness of the sourcing organization.
Prior to J&JPRD, Janis was in several business development roles for Covance. She led a team of professionals who developed strategic solutions for new business development opportunities that spanned all phases and businesses for Covance (preclinical-Phase 4, IVRS, drug packaging and distribution, central lab, and ECG). Prior to Covance, Janis was with a small biotech company focused on monoclonal antibody production and processing. She held numerous positions including manufacturing, quality assurance, product management and alliance management. Janis is a Certified Outsourcing Professional and has been a chair, invited speaker, and panelist at numerous conferences. She holds a MBA from the University of Delaware and a BS in Chemistry from Towson University.
Who Should Attend?
Clinical Operations and Data Management Professionals
- Clinical Trial/Clinical Study Management
- Clinical Data/Informatics/IT
- Clinical Outsourcing
Clinical Research, Technology and Business Professionals
- Business Technology/Applications/Solutions
- Business Analyst
- Project Management
Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend’s Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, and medical monitoring initiatives. Comprehend gives life sciences companies a new source of competitiveness and the confidence to deliver high quality trial submissions at a new speed. Comprehend: the speed to quality results. Learn more at www.comprehend.com
The Avoca Group
The Avoca Group is a driving force behind the continuous improvement of outsourced clinical research. As a developer of progressive solutions to challenges faced in clinical research, Avoca makes a tangible difference to the operations of pharmaceutical companies and clinical service providers.
A pioneer in clinical outsourcing research and consulting, Avoca has for years both tracked and influenced the progression of the sector, making it the ideal partner for companies seeking to better understand the dynamics of their business relationships today, and establish structures to improve the management of those relationships tomorrow. Avoca’s clients include top five pharmaceutical companies and global contract research organizations, as well as small companies within the pharmaceutical industry.
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