Lean and structured authoring
Factual information for easy interpretation
Improved efficiency through tabular formats
Too bad the exchange standard of regulatory dossiers is primarily based on PDF documents. By applying structured content approaches, the auto-population of data in tabular formats is a matter of programming and lifecycle of data in a regulatory information management system.
Start with lean authoring and structured content management (SCM)
Our consultants train Regulatory-, Technical- and Medical writers on where to provide what information across CTD documents and will educate them on lean authoring, formulating clear statements and firm justification. This leaves less room for misinterpretations and unnecessary questions from internal reviewers and external regulators.
Qdossier has been involved in various structured content projects and we are more than happy to share this expertise and guide SCM implementation projects.
'Sending unambiguous messages requires the ability to pretend being the recipient.'
Transfer concise and unambiguous messages
Transfer of messages is not about what is sent, but about how it is received. Too often regulatory documentation contains gobbledygook (language that is meaningless or excessively technical). Too often, authors put their full train of thought in writing, assuming the recipient has the same background information for understanding what was meant.
Lean concise messaging clarifies what is meant and what is not meant. Reuse of the same messages in different context also adds to the understanding. It was Mark Twain who wrote ‘I did not have time to write you a short letter, so I wrote you a long one’. This is exactly what happens too often in regulatory documentation, causing different and unintended interpretations. Moreover, redundant information becomes hard to manage in the future dossier lifecycle, resulting in inefficient use of resources and increased risks for inconsistencies within the dossier and/or across dossiers. These inconsistencies cause a regulatory compliance risk and does not build trust in reliability of the documentation as a whole.
Qdossier’s best practices define that factual information is to be presented in tabular formats. One will be surprised how much information can be presented in a table, which is more intuitive and unambiguous than a narrative text.