Pharmaceutical Project Management IN Information Technology Era

by Hugh G. Davis, Senior Instructor , Kriger Biopharmaceutical Career Training Program www.kriger.com , info@kriger.com

This article has been published by the International Biopharmaceutical Associationwww.ibpassociation.org

The project is sponsored by KRC CRO and training services ( www.kriger.com ) and ClinQua CRO (www.clinqua.com )

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To find the proverbial needle of information in a haystack of data, biopharmaceutical organizations turn to knowledge management systems. Finding it is no small feat, but managers are increasingly focusing on ways to reuse that needle throughout the entire organization, to stitch together successful drug submissions and improve operational efficiencies.

Consequently, biopharmaceutical companies are turning to document or content management systems with workflow features to run more efficient organizations. Systems such as those from Canto, Documentum, Open Text, and Xerox, are being used primarily to create a searchable repository of files. Once a repository is in place, organizations will also add a structured, collaborative system that efficiently manages and reuses the information throughout a drug's entire cycle, from R&D to post-approval marketing.

Most biopharmaceutical companies focus a large effort on setting up formal procedures for managing normal documents. Typically, documents start life as Microsoft Word files, which then get reviewed, edited, and approved. Later on, many companies convert these files to Adobe Acrobat PDF format because of more options to lock down the content.

At some stage, work on a document is completed. That usually results in a large collection of Word and PDF files, which is no problem for many document management systems.

But a shift is occurring that is altering some of the requirements for selecting a management system. For instance, it has been found, many times, that what started out as a traditional document management effort quickly expanded to include electronic documents, Web content, and rich media (such as artwork, packaging, and training information).

Incorporating these alternative types of data into one content management system allows re-use of information in additional ways. For example, products sold in Europe might require a package insert with information in 10 languages. The information is sent in English and goes to subsidiaries in the 10 countries to be translated into the native language permitting simultaneous dissemination to a much wider audience.

Today, most document systems that support these needs are traditional, where a Word or PDF file is handled by a content management system. But as the industry starts to adopt electronic submission using, for example, electronic common technical document (eCTD) specifications, companies must go through a great effort to put information in the right form, and they must do that many times over.

Indeed, when it comes to managing such documents, the pharmaceutical industry lags behind other industries such as automotive and manufacturing. These industries have lots of technical documents and continuously updated information that must be inserted into those documents. However, using eCTD within the life sciences would mean adopting a more ‘granular’ approach to handling information, with eCTD, the documents are broken down into very small fragments.

A good example is a clinical trial report. Currently, a revamped version might be sent to someone using Microsoft Word, who can see the modifications to the document by turning on the word processor's Track Changes option.

A better approach would be to use a granular document and send only a page that lists which elements of the document changed, along with the date and version number of any changed items. But implementing such a change is unlikely to happen on a wide scale anytime soon.

Contemporary Pharma IT developers are already using traditional document management techniques in a granular approach to support multi-element package inserts, and a re seeing the benefits of having a standard operating procedure and workflow policies in place throughout an organization.

For all the options available to manage information, the common thread that cuts through all applications is the need to ensure that proper policies and procedures are followed when information is created, approved, and saved. In that way, many groups within an organization can safely reuse the information, thus realizing the benefits of operational efficiency.