Document review in pharma and medical device enterprises is a system of diverse and complex functions that requires proficiency in technology, process discipline, and most importantly intellectual capital.
In terms of technology, there is the management and optimization of the review platform capabilities, the appropriate use of technology assisted review, and effective data security controls throughout the documentation life cycle.
As we think of process discipline, there is the need for various robust policies and procedures and a commitment at a senior level to execute those policies and procedures consistently and effectively. Additionally, there is the need to carefully consider the right time/correct role deployment of people during the various reviews.
As for intellectual capital, I mean there is effective knowledge transfer; knowledge retention; learning, training, technological, statistical, and linguistic acumen applied to every round of review. In essence, the careful curation of document review expertise.
Taking a hard look at review, there are a lot of moving parts and as time lines are reduced and the scale and complexity of document platforms rise, the need for a well-functioning environment rises exponentially and perhaps even geometrically.
From my perspective, this means, the value of organizational competence in document review as denoted by process maturity far exceeds the value of the component parts (people, process, technology). In short, the best technology (if one exists) and the “best” people may be utilized, but if the organizational vision within which they operate is deficient, the result will most likely be sub-optimal. It is process maturity that provides the framework in which the contribution of people and technology can excel or be inhibited.
When it comes to document review in pharma and medical device, I keep thinking about Peter Senge's comment: “Organizations break down, despite individual brilliance and innovative products, because they are unable to pull their diverse functions and talents into a productive whole.”
Gregory Cuppan is the Managing Principal of McCulley/Cuppan Inc., a group he co-founded. Mr. Cuppan has spent 30+ years working in the life sciences with 20+ years providing consulting and training services to pharmaceutical and medical device companies and other life science enterprises.