Change is a constant in the world of clinical study planning. In The Art of Making Changes Part 1: Five Keys we talked about the stress change can generate, and about the five essential elements for achieving painless change management for IRT (IWR/IVR) systems. The present article outlines the components of a successful management process for technical change.
Doctors will tell you that change – any sort of change – is hard on humans. As endocrinologist Hans Selye observed, “Stress, in addition to being itself, is also the cause of itself and the result of itself.” Good changes and bad changes alike elicit stress points on psychological scales.
Most clinical trial Project Managers will say the same thing applies to managing changes in clinical studies – especially those that impact data systems (e.g., EDC, IRT/IVR/IWR, etc.)! This includes configuration changes, protocol changes that require changes in how a technical system functions, data changes, process changes…and more.
The recent Outsourcing Southeast conference in RTP, NC highlighted one of the hot topics currently buzzing in the pharmaceutical industry, i.e., the need to define and implement a more patient-centric model of clinical trials.
The concept of patient-centricity in the drug development world consists of several basic struts:
• Engage subjects/advocacy groups as partners in the process
• Develop protocols, processes, and systems that are maximally user-friendly (i.e., long on feasibility, convenience, and common sense)
• Put patient interests and point of view on equal footing with corporate research objectives
Perhaps one of the most inconsistently fulfilled industry regulations in the world of clinical trials is the process for document management, including policies for document retention. Companies vary widely in their approach to these important aspects of drug development record-keeping despite the longstanding industry axiom that says “If it isn’t documented, it didn’t happen!”
David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider that has been successfully deploying IRT systems globally for more than a decade, has a Master’s degree in Information Science and has spent much of his career, first in large CROs, then as IRT co-owner, establishing Standard Operating Procedures (SOPs) for compliant quality control of clinical trial documentation.