Calendar Creator (CD-ROM)
By Encore Software

Buy new: $19.99
4 used and new from $10.99
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First tagged "software" by T. J. R. "way up north"
Customer tags: calendar software(3), software, encore, creator, calendar creator, calendar, broderbund

In the pharmaceutical industry the clock is ticking at the rate of warp-speed "drug years." Pharmaceutical industries have 8 (possibly up to 12 years) to discover, conceptualize, define, develop and commercialize--as opposed to market--pre-market drug information. This process of course results in a financial tab of about $200-$900 million dollars--numbers that are subject to vary depending on your sources and on the amount of time taken for the various phases of drug development. At any rate however the monetary costs of a new start-to-finish drug (and more so for failed drugs) are likely to be impressively enormous. No matter how you look at it the pharmaceutical wallet becomes reciprocally thinner as the "drug-years" clock continues to tick.

Drug Patents: How can pharmaceutical companies achieve the greatest patent advantage without compromising patients?

Another motivating factor for pharmaceutical industries to rush the clock are patent laws. Drug patents, of course, create a window--a very large window if strategized correctly--to a monopolized gain on the sale of a new drug. Current laws place patent years at around 17 so if a company spends 11 years in the development phases it has exactly six uninterrupted years to achieve market gain to the fullest--no easy task for even the BIG guys.

Both financial costs and patent pressures cause pharmaceutical companies to rush, to lose their opportunity for sales completely, or worst case scenario, to cause eventual problems, even death, for patients. How can pharmaceutical companies achieve the greatest patent advantage without compromising patients?

Enter Web Document Management

Web document management, when utilized in small, medium, or large pharmaceutical companies and in conjunction with their satellites and CROs can literally shave drug years off the pharmaceutical clock. Web document management solutions combined with web process, quality, regulatory, training and submissions preparation solutions can subtract even more drug years leaving more free-for-all patent time. Best of all however these solutions systematize and automate solutions, trend information and make it easier to get quality, regulation, training, documentation and all company processes under control so that patients stay safe and pharmaceutical companies gain.

As in so many instances technology steps in and effortlessly ties two endeavors together with increased effectiveness on both ends of the spectrum.

One Solution at a Time: Start with Web Document Management

For pharmaceutical companies that cannot invest in all of these solutions at once, start with a web document management solution. A web document management solution will and should be able to manage tens of thousands and even hundreds of thousands of documents from lab notebook entries, study data, biomarkers, formulation studies, statistical analyses, GLP compliance docs, patent analyses, lead generation reports, market analysis, financial statements, manufacturing scenarios, patent filings, product commercial path scenarios, IND submission strategies, toxicology reports, templates, etc., etc.

The web document management solution should also provide web-based collaboration features, the technology to quickly scan paper documents into the system, a user-friendly interface, tracking/audit trail features, 21 CFR Part 11 compatibility, revision controls, reporting features and compatibility with training software controls. The system should also be compatible with common ERP solutions.

Conclusion

When used correctly technology (such as the increasingly popular web document management software solutions) is always an enabler and essentially allows pharmaceutical companies the ability to get the data they need faster so that the right decisions can be made for both patients and the interests of the company and its employees. Pharmaceutical regulatory, quality, IT and management representatives should select four or five web document management software vendors and compare them seriously. The web document management software vendor chosen could be the means of a pharmaceutical company's success after its next successful IND.

Marci Crane is a copywriter at MasterControl in Salt Lake City, Utah. For more information about web document management in pharmaceutical environments, please feel free to contact a MasterControl representative.