Continuing the discussion about digital transformation strategies in clinical research, the People angle, which would be the most critical angle.
Like any other business process reengineering, it is people who will make it success or failure. It is more important in digital transformation, because in effort to make people more powerful and effective, and, empower them with accurate data and insightful intelligence for correct decision making, in a way, we are also generating indirect fear – making them irrelevant.
In spite of being far from truth, this fear, if not satisfactorily addressed, can make things worse.
Earlier, digital transformation strategists used to face opposition in the name of GxP compliance and CSV guidelines and so on… There was also dearth of knowledge about clinical research as a subject among group of IT professionals as the subject itself is niche. Now, with the guidelines readily available, and interpretations more or less standardized, the knowledge about the subject and GxP requirements is penetrating faster among non clinical research professionals.
While we talk about people in digital transformation in clinical research, there are sponsors, there are employees, there are regulatory agencies and there are partners. As far as clinical research goes, they cannot be distinguished or segregated and taken into confidence one after another. Rather, one needs wholistic approach to bind all of them in comprehensive single outcome.
Clinical research is a knowledge industry and people are at core in knowledge industry. When we enable digital transformation, we also tag processes and data around people to make them more efficient and effective by eliminating redundant processes and repetitive efforts.
Also, there would be paradigm shift in certain type of work, for example, Quality control, who is responsible for control in-process quality by routine monitoring, can now strategize and implement process work flows and data validation rules in digitally transformed clinical research processes.
However, from organizational perspective; lots of practices on human capital management front needs to be redefined or changed – and the most important would be reskilling people. Fair amount of repetitive and mundane tasks would be replaced with analytical and result oriented monitoring.
As digital transformation sets it, continuous training and learning would become necessary for each and every employee at all the levels. Unlike other industries where digital transformation requires complete skill transformation of many people, here at clinical research, one can easily run reskilling workshops and change management sessions.
In conclusion, to be successful in digital transformation, CROs need to embed digital capabilities in working procedures.