When we talk about ‘Digital Transformation’, there are wide range of definitions – the simplest covers digitization of processes, to more complex one that talks about complete revamping and reimaging the business in the era of digital technologies.
Of course, in terms of clinical research; when we talk about digital transformation; we are not thinking in terms of complete revamping and reimaging the business. The research which deals with human life and is done on human being; that makes the same prone to very conservative, step-by-step approach. Interestingly, it is increase in human life span and improvement in quality of life which are most critical value proposition for any research; but penetration of technology has to be slow and cautious.
This is also the area where correct interpretation of regulatory guidelines and implementation of digital transformation strategy in clinical research around the same requires fine balance. Here, by bringing in digital transformation, we are not anticipating large scale disruption; but we are cautiously inching towards improved processes, accurate data accumulation and actionable intelligence around the same. As a result, we are also achieving our ultimate objective of improving safety and managing risk of volunteers and patients participating in such research.
Most of such clinical research projects are tightly driven by well-defined SOPs (standard operating procedures). Digital transformation will require either to disrupt or reengineer such procedures. Digitization around existing SOPs can only serve one purpose — of digitization but would not be able to drive benefits of process excellence, machine learning, artificial intelligence and deep learning. The purpose of deriving benefits around improved safety by capturing early signals, trending alarms and risk mitigation cannot be undermined or ignored.
Unlike most other businesses where digital transformation is expected to radically improve the performance and reach of the business, digital transformation strategies in clinical trials will need to be circled around GCP – Good Clinical Practices, GPVPP – Good Pharmacovigilance Practices, GLP – Good Laboratory Practices, CSV – Computer System Validations, 21 CFR part 11 compliance and other well established norms and practices.
As any other business, digital transformation strategy in contract research organizations (CROs) is formed around people, processes and tools.
This was the first; discussed about processes. We will discuss about tools and processes in upcoming articles.
