For a period of time I was the only medical writer in a small contract research organization (CRO), working closely with the regulatory affairs department. I learned some project management skills that, I later realized, are valuable tools for writing large, complex regulatory documents.  Regulatory documents, such as clinical study reports, clinical summaries, and overviews, require many interconnected deliverables from numerous team members with constantly shifting timelines. Any delay in one deliverable can potentially result in a large downstream effect. The regulatory writer is a ju ..read more

When I was first given the timeline some months ago, my first thought was "It cannot be done." The company was planning to file an NDA. Two phase 3 studies were to reach database lock in June. I, the lead medical writer on one of the clinical study reports, was requested to complete the first draft of the results (Sections 10 through 13) in 4 working days and the entire document, from TFLs to sign-off, in 3 weeks. I am a fast writer. I have written several first-draft CSRs in three whole days. However, those CSRs were small --- phase 1 or phase 2, involving no more than 50 subjects. The endpoi ..read more

The overarching goal of any drug research and development effort is to find a safe and effective treatment for a disease and get it approved for marketing. This is why regulatory strategies are relevant to anyone involved in this process, even if you are not making critical decisions, such as whether to invest millions in clinical trials that could decide the fate of a molecule.  Ultimately, the fate of a molecule is in the hands of the FDA, which may seem like a monolithic bureaucracy but is an organization just like any other, composed of thousands of physicians, nurses, pharmacists, scient ..read more

Over the years I have written documents of all types and all lengths, ranging from a one-page clinical overview to a 300-page, single-spaced CSR (not including post-text tables and listings, of course). Some studies can be large and complex, with multiple doses and treatment groups, dozens of exploratory analyses, and acrobatic statistical maneuvers. It takes meticulous patience and tenacity to build a long document, brick by brick, sentence by sentence, one table at a time.  The complexity, however, goes beyond the writing. It is the project management aspect that can often pose greater chal ..read more

This may sound like a rhetorical question, but I have worked with many people in the pharmaceutical industry for whom readability is not high on the list of priorities. For documents to be submitted to regulatory agencies, the accuracy of data and compliance with regulations are certainly the most critical concern. After this, however, importance can vary widely among members of a drug development team on specific issues, ranging from strict adherence to in-house templates and styles to how many tables should be replaced by figures. More often than not, team members just want each document to ..read more

This is a question I am asked a lot. Even people who hire freelance regulatory writers do not always have a clear idea on what to expect. It is true that the experience and expertise among regulatory writers can be vastly different. Some can do a, b, c, and d, but not e and f; others can do a, c, d, and f, but not b and e. For example, I can write INDs, clinical summaries, and CSRs, among other things. However, when I was asked to design a CRF (case report form), I politely declined. I know how to read a CRF and even edit it once in a while, but I have neither the expertise nor the appropriate ..read more