Automated agility boosts use the of electronic document systems

Until even fairly recently, document management systems have been viewed ambivalently by the pharma industry, seen by many organisations as an ill-afforded luxury; a nice-to-have rather than a 'must-have'. Keeping offices freer from clutter and enabling some degree of automation, systems have appeared to offer some solid advantages, yet with a cost and integration burden that has been unpalatable to some. Until now, that is.

Recent research conducted on behalf of ISI suggests that a shift is taking place. The research, from a series of focus group sessions in late 2007, explored the current concerns and priorities of mid-size and emerging biotech firms. The groups were attended by executives from firms in Boston, San Francisco and San Diego in the US - three high-impact regions in the biotechnology industry.

The study's aim was to establish a better understanding of emerging companies' evolving business models, processes and strategies, and to identify current challenges and requirements.

The findings suggest that attitudes towards technology are changing, under the influence of new industry requirements and mounting competitive pressures. Technology adoption is now happening at an accelerated pace, designed to keep partners and regulators happy, and, as a natural extension, to drive greater cost-efficiency into operations.

Certainly, there is growing demand for submissions to be made using the electronic common technical document (eCTD) standard. Even in Europe, where the practice is not mandatory, or in situations where a company does not have plans to take a drug to NDA, firms still need to produce their documentation in the eCTD format because of pressure from big pharma partners they may want to work with in future.

And, although many mid-sized companies have limited resources and personnel, solutions that can be implemented quickly and at a low cost, and with an immediate impact, such as eCTD-based solutions, have considerable appeal - especially if they promise a positive knock-on effect on other areas of the business too.

Traditionally, use of technology for time-consuming administration tasks has been limited among mid-tier biopharma organisations, due to a lack of cash flow, internal expertise and forward planning. The move to eCTD adoption has begun to change that, especially as this has been made more palatable now by the growing availability of affordable and easy-to-implement software packages.

At the same time, mid-sized firms are beginning to wise up to the strategic advantage of automating more of their activities. The ISI focus groups found that, while most small and mid-size biopharmaceutical companies were still handling most regulatory filings on paper, many were now keen to turn that situation around. Many had an eye on the future too, looking for solutions that could be scaled up as their activities grow, and as they submit regulatory filings in more territories.

While regulatory forces were clearly driving the change, the impetus to invest was also encouraging mid-sized firms to streamline their processes and gain control of their documentation, to integrate their activities more closely, remove duplication, speed processes and improve accuracy. The highest priority was noted to be identifying scalable solutions that would grow with their needs.

For the mid-market company, packaged, 'ready to go' solutions have particular appeal, allowing firms to get started quickly, while minimising the overall cost of ownership. Having been put off large, complex, comprehensive document management systems in the past due to their high cost and unwieldy scope, organisations remain keen to adopt systems that are more relevant to their size of operations.

With this in mind, and noting that the challenges faced by mid-tier organisations extend beyond submissions, ISI joined forces storage specialist, EMC, to develop a collaborative, multi-dimensional solution for this under-served market. The resulting pre-packaged, integrated regulatory compliance solution, Compliance-in-a-Box Submission Edition, enables midsize and smaller companies to build affordable regulated document management and compliance solutions.

Since software alone can't achieve miracles, firms need to prepare themselves for change and strive to become efficient, streamlined businesses, with defined processes and centrally managed documents and data. As long as they continue to foster a silo mentality, with poor communication between departments and a disjointed approach to technology implementation, efficiency, productivity and competitiveness will be compromised.

Again, smaller firms have the advantage, typically being more cohesive and nimble. Add greater document control into the mix, and smaller or midsize pharma organisations can exploit this deftness to their competitive advantage. Failure to properly manage information and documents increases an organisation's risk of losing or misplacing critical documents and data and, potentially, the loss or theft of intellectual property.

The ideal scenario, then, favours a shift to a centralised electronic document management system (EDMS) and eCTD publishing solution.

The rise of hosted solutions

Companies hesitant about being too ambitious, not least because of cash flow limitations and a lack of internal resources to manage and support new systems, are finding the remotely-hosted, 'pay-as-you-go' software delivery alternative holds great interest. This offers access to the latest technology without fear of obsolescence, or the burden of having to manage and support the IT systems themselves. Costs become predictable and spread out (and can therefore be planned and budgeted for), while ownership and support of the software and hardware systems remain someone else's problem, reducing internal administration costs.

For mid-market organisations that need to rein in expenditure while remaining nimble, this is an ideal alternative to making a potentially large capital investment in specialist software.

If firms want to take the benefits even further, they can farm out some of the related, non-core business processes, too. Professional managed services now exist to support almost every function, from drugs application submissions, clinical trials and post-submission tracking, to medical writing, regulatory consulting and training. But perhaps the biggest plus of all is the flexibility and scalability offered by the SaaS delivery model. Because the firm doesn't own the IT systems, but merely 'rents' them, it can switch the functionality on and off (paying only for what it uses).

If a new cross-licensing agreement is reached, or a merger is on the cards, additional capacity can be added quickly and easily. This is also an advantage given the sheer scope of the molecule-to-market drug development lifecycle, and the relatively sporadic need for different software systems at the various stages.

The cost of ownership arguments for SaaS are highly persuasive. Whereas, in the traditional software purchase scenario, every US$1 spent on a software system typically generates a further US$3 in validation, project management and resource allocation, these figures are radically reduced with the SaaS model. Here, firms stand to eliminate each US$1 in ownership costs along with US$2 of the US$3 spent on administration and support. Instead, they pay a nominal set-up charge, and a modest and predictable pay-as-you-go service fee.

This affordability also means that software functionality can be employed tactically, for short projects, if needed. The 'rental' model makes this financially viable, because they are only ever paying for the capacity they use, while rapid deployment helps build the case, too (while firms implementing their own software systems internally might have to wait six to 12 months before a new system has been specified, fully validated and rolled into production, tapping into a SaaS-based system could give them the functionality they need in a matter of weeks).

It's not just smaller firms that can benefit from this. Even those at the upper end of the market can see the advantage. Showing just what's possible, pharma giant Boehringer Ingelheim chose to invest in a SaaS-based system last year because it was rushing to meet the fast-approaching deadline for eCTD electronic submissions.

Tight FDA deadlines precluded developing an in-house system so Boehringer Ingelheim opted for the SaaS solution. This not only ensured rapid compliance, but also allowed the firm to cut internal support costs by 40 per cent compared with the alternative. What's more, Boehringer Ingelheim retained the option to resume ownership of the systems at any point, giving the firm complete flexibility for the future.

Mid-size firms stand to benefit in much the same way, particularly as their capital budgets and internal resources are relatively modest.

- Adam Sherlock is Managing Director of Image Solutions Europe. For more information, www.imagesolutions.com.

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