Life science companies can be considered risk-averse and stick to paper processes. When teams find a way of approaching electronic solutions to process data, it can take a real effort to break the cycle and be more receptive to newer and smarter approaches.
That’s the exact situation the industry currently finds itself with regard to content and how it is exchanged with health authorities. Organizations are logging and tracking data in Excel and in databases, often multiple databases within the same company. Yet when life sciences firms submit and exchange information with health authorities, they predominantly use narrative documents. When dossiers are received by health authorities, they extract the information from documents and enter that in a database. Only for administrative changes (Type IA variations), this accounts already for 200 FTE across EU agencies and at least as many FTEs in industry. What can be done to steer a path towards a smarter approach of structured content management?
Part of the issue is that when exchanging information with a health authority, much of that information is contained in a narrative document. It is structured in a way that makes tagging a real challenge, and is frequently riddled with inconsistencies, a blight on any data set.
If someone has written articles for scientific journals, then they are used to writing in long sentences, with lots of references and using different words for the same subject. Using this style in regulatory documents, which must be structured to maintain compliance, means too much woolly information resulting in inconsistencies and an inability to link a single effect to a single source.
So the exchange of information can be far more effective and efficient than it is currently – this is where structured content authoring, built on standard terminology can play a major role.
Structured content authoring
There will come a point where most content will be structured content - planned, stored and managed in a way that makes it easy to deliver and exchange, and to extract meaning and insight from.
Structuring content in graphs and tables makes it much easier to tag according to international standards. If information is tagged correctly, documents can be a carrier for the data, meaning health authorities can upload information into their databases, as tagged accordingly. This is much easier for industries to produce documents and authorities to interpret documents. The overall exchange back and forth is much more straight forward.
Structured content management carries data from a data management system to documents that can be compiled into dossiers, a true combination of factual information and scientific evaluations. This works only if the organization has reliable data in its databases and is committed to getting rid of old habits when creating content.
Life sciences is a heavily regulated industry, and health authorities want increasing volume and types of information from life sciences firms – more consistent information and more up-to-date information. Yet adding resources is not the way to address this, and those in the industry need to think smarter about how they manage data and embrace structured content authoring more fully than they have to this point.
To read more about how Life Sciences companies should embrace change when it come to content creation and structured authoring, read Romuald Brauns article in Pharmaceutical Manufacturing, "What Life Sciences Firms can Learn From Other Industries About Optimizing Routine Document Production."
Hans is Director of eCTDconsultancy, a Dutch company that advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes and procedures related to scientific/strategic and operational aspects of drug development. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. He has gained a wealth of experience and a comprehensive view on what is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. Hans has built up a solid reputation as a consultant for the pharmaceutical industry and is a popular and respected speaker at many regulatory congresses.
Ralf Heineke 2min read 15/08/18