A Holistic Approach to Clinical Studies – The Cenduit System Design Center of Excellence
At Cenduit, we’re always working to create innovative strategies and methods to improve clinical trials, from concept throughout the entire lifecycle. This year, we’ve established a System Design Center of Excellence to help our clients navigate the many complexities of their clinical studies, through specialized global service delivery teams.
Creating Unparalleled Competencies in People, Processes and Technologies
Our passion is to achieve excellence throughout every facet of every trial. The Cenduit System Design CoE demonstrates Cenduit’s unique model and holistic approach of designing trials for change. Our Project Management Group (PMG) launched the System Design CoE to maintain the highest corporate standards in competency, processes and technologies. The goal is to expand the breadth and depth of Cenduit’s global team of System Design PMs, who are specialists in various aspects of clinical trials and complex therapeutic areas.
The System Design CoE - as does every Cenduit Department - maintains its own set of experts and quality standards to lead the most critical initiatives in order to have a positive impact each client’s study. Everything the System Design CoE does is focused on improving study delivery for clients through study design and consultation, quality across our people, processes and technology, and ensuring our processes support rapid turnaround for studies and amendments.
The System Design CoE establishes a consistently enhanced framework of processes, tools, templates and trainings; designed to proactively guide PMs through solutions, challenges and opportunities in clinical trial study design. There are four key focus areas of the System Design CoE:
Competencies – Helping PMs expand knowledge as subject matter experts in all aspects of IRT study design and study maintenance
Tools – Ensuring our PMs have the tools needed by working closely with R&D and Cenduit’s OPEX Group to enhance tools and templates in Cenduit’s IRT and the Quantum Interactive™ design platform.
Processes – Continuous evaluation and improvement of operational processes improve quality, increase efficiency and reduce study delivery timelines.
Resources – Ensuring PMs have access to the right knowledge, expertise and materials, with metrics and measurements monitored to facilitate identification of areas for further analysis, action, and improvement.
As with every Cenduit initiative, the System Design CoE also maps to the principles of Operational Excellence (read Vice President of Operations Jinu Jose’s blog on Industrializing Operational Excellence through Quality, Innovation and Expertise here).
While the System Design CoE is a separate entity from the Cenduit Drug Supply Center of Excellence, they can and do work together to support clients’ study objectives.
An Innovative Framework to Build Knowledge and Expertise
In developing the System Design CoE, Cenduit has established a common authority and framework that enables us to offer invaluable education and insights, as well as a centralized forum to bring the best ideas to light. A number of initiatives reside under the System Design CoE umbrella.
● Improving technological knowledge – Through collaboration with different Cenduit departments – in particular sharing lessons learned with R&D and the study development teams – the System Design CoE has a positive impact on the technological proficiency of every PM. It also ensures that learnings are shared and not siloed.
● Improving tools and documentation – Experienced PMs work together through a variety of initiatives to give our PMs the precise tools and templates they need to ensure standardization in quality trial design and build, rapid delivery, and seamless changes as needed.
● Master Classes, trainings and workshops – Educational programs taught by our senior PMs and Technical Consultants build knowledge and core competencies in specific therapeutic areas and indications. For example, oncology trials often dispense drugs to subjects at home as a part of a virtual trial (or decentralized trial) offering, and entails a unique set of system requirements. The SDPM CoE tailors training, workshops or other activities to address these unique considerations.
Through these and other System Design CoE programs, PMs learn and evolve proven strategies to seamlessly manage study builds, protocol amendments and system changes during every phase, while maintaining optimal productivity and efficiency.
Let’s start the conversation about how we can bring a new level of quality, innovation and expertise to your clinical trials.
Posted by Cindie Kazmer, Senior Director of Project Management; and Maxime Schuchewytsch, Project Management Consultant
