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European Pharmaceutical Contractor
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| Nancy Smerkanich of Octagon Research Solutions charts the evolution of electronic submissions, and calls for a convergence of standards within the regulatory arena
Over the past 10 years there has been an evolution in electronic submissions to regulatory authorities both in the US and Europe. Companies who develop drugs for the purpose of marketing them in multiple markets were early adopters of the technologies that facilitated electronic document use and reuse for these purposes. This evolution was initially driven by the US Food and Drug Administration (FDA), but the EU has been involved, through the activities of the International Conference on Harmonization (ICH), in developing the standards that will take current submission formats to the next level, namely the electronic Common Technical Document (eCTD). This article attempts to provide the history behind eCTD as well as the direction and areas it can and most likely will move forward.
TECHNOLOGY PLATFORMS
There are some basic technologies or platforms that have formed, and will continue to form, the basis for electronic submissions. The first of these is portable document format (PDF). Word processed documents can be easily converted to PDF and have the advantage of preserving the formatting of the document in which they were created. In addition, as the functionality of the software for creating these documents has matured, there are many more features that can be leveraged that add navigation to the PDF documents. These include: hypertext linked tables of contents; heading styles that convert to bookmarks; and cross-references that are retained as hypertext links within the document. PDF documents can also be created from image-based sources, but with less functionality.
Text-based PDF (that is, where the source is a word processed document as opposed to a scanned image of a paper document) can be searched by term and can easily be cut and pasted, using readily accessible software, into documents and reports by agency reviewers. Because PDF documents preserve the format of the original or source documents and because they can be viewed through the use of tools such as Acrobat Reader (freeware), they became acceptable as both the review copy as well as the archive copy of the submission. |
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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