Archive for December, 2009
Designing Documents for the Regulatory Reader
Over the years I have heard numerous presentations or read articles by regulators at FDA that suggest the documents submitted by pharmaceutical and medical device companies are not designed to support the reader tasks of the regulatory reviewer. When considering these comments, I’d suggest the core problem is that these documents are written from the [...]
Blended Model for Writing and Review
To address the complexity of authoring documents like clinical research reports, most pharmaceutical organizations apply the “blended” model for writing and review. The research report has a lead writer, commonly referred to as the medical writer, who is responsible for compiling sections from contributing authors—typically a biostatistician and a clinician. In the blended method, the [...]
Consider Review Best Practice
To create high-quality life science research and development documents in the most efficient manner requires applying review best practices.
Best practice recognizes the differences between the task of reviewing a document versus merely inspecting the document for matters of accuracy and style.
In best practice, reviews take place at various stages of document development and no matter [...]