Serving the Pharmaceutical Industry
The Sooner the Better
As a drug industry professional, you know that the government is your first
customer. Every new drug must be approved by the FDA (or another government
agency outside the U.S.) before it can be put on the market and every day they
spend reviewing your application is one more day you're not getting revenues for
your product.
This brings us to your other "product": documentation. You have to
prepare this documentation for your New Drug Application. As you know, the data
has to be in a format the government reviewer can use.
But you can do more than just meet the minimum requirements. After all, the
more effectively government reviewers can browse this documentation, the sooner
you can start selling your drug.
When preparing a New Drug Application, there are two ways to save time:
- Get it to the government as soon as possible.
- Get it approved by the government as soon as possible.
The second item is not beyond your control. You can speed up the government's
review process by converting your information to a format the government can use
effectively and efficiently. But first things first...
Get it to the Government
Getting an NDA to the government often means converting your documentation.
The question is, how are you going to do it? One option is to try to do it in
yourself, but an in-house solution is not going to save time if you wind up
having to extensively revise the converted material, or worse, sending
substandard and/or inaccurate materials to the government.
A thorough setup phase will allow you to do it right the first time and, with
the proper resources, you will be able to automate much of the work. Working
with a conversion expert enables you to accomplish both goals.
Data Conversion Laboratory was hired by Acme Drug Company (actually a
composite of the many drug industry clients of DCL) to convert 100,000 pages of
Interleaf documenting its New Drug Application to Folio, which their government
reviewer likes to use.
Knowing the format is not enough. DCL knows from experience that there are
multiple ways of laying out and structuring data, so when Acme delivered its
first set of Interleaf documents for conversion, DCL worked with the customer to
eliminate ambiguities. By delivering a sample, DCL helped Acme to visualize the
end product, which enabled them to better understand what their needs were and
to determine if those needs would be met.
Next, DCL developed a conversion specification, which thoroughly itemized all
of the elements to be converted. This document is an important service to our
clients as it defines and standardizes the conversion, allowing for as much
automation in the process as possible.
Automation is key to saving time and effort. Because DCL has extensive
experience in all areas of data conversion, it was able to guide Acme in mapping
out the most cost effective way to combine automation with manual editing and
review. As is typical, the time for marking cross references and index entries
was cut in half by DCL's process.
Get it Approved
The condition of your data is key to its approval by the government. First of
all, it needs to be accurate. DCL guarantees 100% text accuracy for converting
electronic data. Data that must be keyed from hard copy can be double or triple
keyed and then proofread for accuracy rates upward of 99.995%.
But accuracy of the text is not the only issue. Is the NDA formatted
correctly? Such concerns are subjective, and some people feel they can't explain
everything they need. That's why DCL works closely with the client, using such
feedback mechanisms as the conversion specification, samples and weekly
deliveries and reports. In this way, DCL develops requirements that accurately
reflect the client's needs. The data is then guaranteed to comply with these
requirements.
When it comes time to review your converted data, you'll find that cleanup
and rework of layout and formatting has been minimized by our internal quality
control process, which allows you to focus your review on medical and
engineering issues. We facilitated the review process for one client by
providing a scanned image of every page of hard copy linked to the electronic
data.
But there's no reason to stop at being accurate. You can also speed up the
process by making the document as easy to browse as possible. Government
reviewers rarely go page by page through a New Drug Application. For one client,
we installed links to allow the reviewer to go from one part of the
documentation to another with just the press of a button, based on the client's
projections of where he/she would need to look.
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