I am right in the middle of a 3-month consulting project to review data traceability through one function in a customer’s business. It’s a complex system of business processes involving multiple stakeholder groups across EU and US; we are only scraping the surface to give an initial overview. One point that stood out quickly is that data or information transparency is a common challenge across groups and processes.


Information transparency is a hot topic in life sciences today. Two frequently discussed areas are big data and risk based monitoring. Risk based monitoring for us is all about information transparency – if you don’t know what is going on and what matters, how can you make good decisions? In the big data area the discussions I have followed have focused on applications such as CROs leveraging their experience to guide site selection, or pharma being able better to mine information from trials. Yet it seems there are lots of other areas where a lack of access to the right information causes reduced efficiency and effectiveness: One example I have seen in both CROs and pharma is incident/CAPA systems that don’t provide global reporting built on processes that silo knowledge on issues and solutions. Another is HR and learning solutions that do not mine the knowledge of the organization and the wealth of information available from external sources, and do not empower the employee. A third is a discussion I just had last week about how to effectively track work in progress in a software project configuration shop; something that was a significant challenge in my past lives.


In the current project the information points needed and their attributes are fairly simple but many different groups use them. This leads to duplicated data entry, storage in multiple systems, redundant and duplicated paperwork, e-filing of PDFs etc. Moreover the fragmented nature of the system is mirrored by a lack of visibility across the process. If we imagine laying out the high-level end-to-end process we should be able to point to where any particular unit of work or data is at any point in time. The inability to do this isn’t something new for many companies I suspect, but the ability to do it will surely be a competitive advantage for companies in the information age. Just look at retailers like Wal-Mart to see the advantages they gain from being able to effectively and efficiently manage movement of information and/or stock.


Of course there are quick and easy answers to all of this – catchphrases such as “business intelligence”, “reporting layers”, “visualizations” etc. Yet the truth is that the lack of visibility is as much a symptom of the way the people and process are organized. To get the maximum savings and improvement to quality from applying these technologies we need to first re-engineer people, process and tools to simplify and facilitate information transparency. Example – if you have the same information recorded in 3 places, which is the “source”? Once you decide that and you know you will be giving visibility across the siloes, why record it in the other two places? Whilst re-engineering you can determine what data to monitor and where and when.


Only once the process is efficient and effective can we apply reporting and know it will provide true insights, not just a rear-view mirror to what happened yesterday. Nonetheless, despite the challenges, the future is bright…