People usually use this phrase when trying to describe the tendency to become too involved in the details of a problem versus looking at the situation as a whole. Could this same concept apply to an industry such as life sciences?
During our webcast, “Improve Compliance by Gaining a Complete View of Regulatory Activity” held earlier this week with IDC, we polled the audience.
- The first polling question asked, “Which of the following is a primary concern at your organization today?” 37.5% of the respondents answered, “Eliminating data silos and creating a unified information architecture.”
- The second polling question asked, “What would you consider to be your highest RIM priority in the next 2 years?” 57.9% of the respondents answered, “Centralizing/integrating systems to unify RIM functions (single authoritative source.)”
In an industry where most life science organizations have historically taken a siloed approach to product development—that is, they create, manage, and store information by function (clinical, regulatory, manufacturing etc.); could these survey results indicate a potential opportunity for transformative change?
Well, let’s start with how information flows across the lifecycle of a drug in a pharmaceutical company today. As a new compound is discovered and goes through non-clinical and clinical testing, information must be shared internally with Regulatory Affairs (and ultimately with health authorities) in order to gain approval. Information from across the drug development process must be shared and overviews, study reports and summaries authored, reviewed and approved. Once an application is submitted to the regulators, there are on-going interactions with them through approval, and then continuing on for the life of the drug. Upon approval, specifications and formulas which originated in R&D, now have to transfer to production manufacturing. And the process continues on through sales and marketing, pharmacovigilence etc.
So, what would the process look like if it was redefined? How transformative could it be? What if information residing in each functional area could flow seamlessly throughout a drug’s lifecycle? For starters, workers wouldn’t have to export and import information from system to system along the drug development lifecycle. By leveraging a consistent data model, information could be linked across solutions. This could reduce the risk and inefficiencies of manually exporting and importing information, stem the proliferation of multiple copies and eliminate the difficulty associated with determining final versions of documents. In addition, this would provide an authoritative source for drug development information and provide detailed audit trails across the process. Most importantly, it could help streamline the process helping to get needed drugs to market faster. This makes sense, doesn’t it? Organize information according to the business process and lifecycle of products rather than by business function.
What do you think? Do you think your organization is beginning to see the forest that includes the trees and embark on this type of transformation?