| According to Peter Reynolds, of Image Solutions Inc, remotely hosted submission software and services could be the key to the dynamism and agility pharmaceutical companies now crave
As the pharmaceutical industry embraces the electronic common technical document (eCTD) standard for drug licence submissions, companies with foresight are seizing this as an opportunity to streamline their internal submissions-related processes to achieve multiple gains.
Drug licence submissions are a necessary evil for the pharmaceutical industry. Fall foul of stringent industry specifications and your company could be closed down. Getting the processes and documentation right is paramount. Yet processing paperwork is hardly core business practice for experts in science. An integral activity it might be, but it is a rare pharmaceutical enterprise that sees efficient processlogging as a competitive differentiator. The discipline required is laborious, resource-intensive and costly, and is something most pharmaceutical companies would gladly offload to a third party if only they could make that final leap of faith required to let someone else co-manage it.
REMOTE SYSTEMS BECOME THE NORM
The good news is that this process has now become much easier. Worldwide, cross-industry acceptance of the benefits of centralising and remotely hosting IT systems, and now buying software functionality as a service (Software-as-a- Service (SaaS)) is giving organisations unprecedented freedom in the way they prioritise and manage their business operations.
With access to broadband communications now taken for granted, and network security integral to companies’ IT infrastructures, organisations large and small are taking the opportunity to move out and centralise their systems, so that these can be managed more cost-effectively, properly secured, and shared more readily. The benefits and practicalities of hosting email servers and other core applications remotely are now taken as a given, to the point where this is becoming common practice even in markets sectors once considered overly conservative and risk-averse, such as financial services and government.
Indeed, respected global analyst firm the Gartner Group believes that this will become the software model of choice by 2008, with more than 50 per cent of all software purchases being made on a subscription rather than licence basis. The pharmaceutical industry provides no exception to the growing interest in on-demand software, itself now starting to embrace the opportunity as a means of unburdening itself of some of the regulatory commitments to which it is bound. While relinquishing control is out of the question, the opportunity to let external experts host and even co-manage the submissions process is a welcome one. |
