Editor’s Note: Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA. He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that.
So, last time, I told you about assembling a team of believers. Those believers are the “customers” you serve on both sides of the fence in regulatory operations. Not only are you getting documents from all the different members of the extended filing team (Regulatory, CMC, Pre-Clinical, etc.), but you’re then serving a different master in your health authority. If you need to review, please read the previous post.
This time, I want to focus on getting the most out of the tools and process which drives your efficiency. Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.
You could certainly PDF all your documents one at a time from MS Word and then code the XML in notepad. But, using the PDFMaker plug-in for word will automatically link your TOCs and cross-references for you and any of the software packages out there made for eCTD will do all of your XML for you. Tools that help you do that work have many different price points, enterprise license options, hosted solutions, etc. Just Google “eCTD software solutions” and you’ll see what I mean.
The point is, you do not need a million dollar, validated system to build your eCTD’s. But, eCTD lifecycle is a serious commitment, so you have to be prepared to have an ongoing relationship with those tools. The maintenance submissions far outnumber the original filing, so getting to know and trust the software companies that make those tools will be crucial to your success. There are point solutions, desktop solutions, web-based systems, hosted systems – the choices are many and varied.
Certainly, outsourcing is trending these days. There are some extremely capable partners with extensive eCTD experience out there. Do your homework, ask colleagues at industry meetings, go to message boards online. No software is perfect, and no vendors are perfect…but, some are better than others. This is a long term relationship you’re entering into, so do not take it lightly.
Be sure that the tools you select maximize your talent pool at your disposal. There are very few MS Word experts out there – so if you have one, maximize that potential and give the authors a break. Medical Writers in Pharma and Biotech do not need to be MS Word experts, but many operations groups do try to force them to be just that. They should be experts on science and data. Keep that in mind as you start to pull your submissions together.
In summary, much like building the best team, choosing the right tools that fit your needs is a very strategic and important decision. Look at all your options and choose wisely. Consider budget, long-term implications, and what makes the most sense for your situation before jumping into anything this big and in order to maximize the efficiency of electronic submissions.