Effective regulatory information management (Reg IM) is about so much more than compliance – or it could be, if only pharma organisations were tuned in to the wider commercial advantages. Yet, according to a recent survey, only 20% of life sciences companies have so far fully implemented a formal Reg IM strategy. Adam Sherlock, director at CSC Life Sciences, expresses his surprise.
In the data-dense world of pharmaceutical R&D having timely access to accurate and up-to-date information is critical, not least to patient safety and internal risk management. It might seem obvious that data used in product submissions, or about manufacturing methods, where products are marketed and so on, could have longer-term value. Yet the silo’d way in which the industry has operated in the past has not been conducive to providing pan-organisational business insight.
Until now that is. Thanks to the introduction of electronic submissions and the development of industry standards for managing data, there has been a growing emphasis on consistent, digital data gathering and content sharing, which in turn has begun to fire organisations’ imagination about how this information could be harnessed strategically and to commercial advantage. Or has it? New research has found that to date only 20% of pharma companies have fully implemented a formal strategy for regulatory information management (Reg IM). The independent study, conducted for CSC by Landmark Solutions Exchange Survey in May this year among senior regulatory information personnel, revealed a significant gulf between where organisations need to be and where they are today.
The study’s aim was to provide a reality check, determining how far companies have come in bringing content creation and management under centralised, automated control, and how they felt about the transition.
The findings started positively. Asked to sum up their perceptions of regulatory IM, more than half of respondents defined it as a “method of bringing together all of the pieces of information and data that tell the complete stories of all products for the purposes of compliance with regulatory authorities’ requirements and improvement of commercial decision-making.” This suggests an appreciation among companies of the importance of getting their regulatory affairs in order as a business priority as well as an administrative necessity. Only 15% described regulatory IM as a necessary evil designed to keep regulators happy.
That as many as 80% of those responding to the survey admitted that they had yet to fully implement a formal strategy for Reg IM is surprising. This is not only due to the strict regulatory requirements (to adopt a more consistent and automated approach to process tracking and reporting, and submissions management), but also because it means companies are missing out on the substantial efficiency benefits made possible by tighter information control and digital content sharing.
The main reason for this inertia, it seems, is an internal skills deficiency. Asked to highlight the barriers they had encountered in introducing a fully-functioning Reg IM solution, 59% cited human issues – ie having the right capabilities in house to implement a system or train users.
Technology challenges feature too, however. Forty-three percent of respondents indicated that they were struggling to create an infrastructure capable of fusing disparate data sources. Combined, people and technology issues are shown to present more of a hurdle than financial constraints; only a third of respondents cited budget as a primary inhibitor to progress, while just 18% felt a lack of senior buy-in to be the issue.
There was some evidence that companies are still short on imagination about the broader benefits of formalising regulatory IM, and this may be limiting their enthusiasm for pushing projects through. Although 57% identified Reg IM as a means of establishing a more comprehensive picture of their operations, only 14% cited enhanced commercial insights and opportunities as the main benefit of the discipline; rather, 89% cited improved internal communications around product submissions and products on the market as the chief advantage they expected. Forty-five percent indicated improved compliance, and 43% accelerated submissions.
Prompted into action by regulatory necessity, it seems the majority of pharma organisations are still at the early stages of Reg IM implementation and have yet to comprehend or quantify the fuller benefits. The bigger picture involves streamlined processes, content re-use and a much clearer view across a company’s activities and performance - which in turn enables commercial decision-makers to understand their business and its strengths and weaknesses at a deeper level.
That a skills gap exists - which may be preventing organisations from making optimum progress - must be addressed to ensure companies derive maximum return on their IT investments, and end up with solutions they believe in and fully support. Being mindful of the reduced burden of administration and stress usually associated with amassing accurate content to meet a deadline, ought to help boost employee buy-in to new processes and systems – because ultimately these will make people’s lives easier and their jobs more rewarding.
It is understandable that life sciences organisations won’t naturally have all of the new skills they need in house – nor should they. Regulatory IM is a largely administrative discipline which can be outsourced to a greater or lesser degree to experienced experts who understand the technology and what’s needed to ensure compliance. Simply throwing technology at a situation rarely delivers the results intended, so organisations need to make sure they attack their project holistically, engaging the right advice and surrounding support services to deliver all possible benefits.
Seen at its broadest level, Reg IM is really about the asset management of a company’s products worldwide. Capturing detailed information about every part of every process involved in every product’s creation, development, evolution, marketing and distribution is highly valuable commercially. If this happens reliably and consistently, and the content can be readily accessed, shared and re-used, the strategic opportunities for the different parts of the business are unlimited.
The whole point of automating a company’s information management and reporting activities, from an internal perspective, is that it lightens the load and gets things done faster and better, giving the organisation competitive advantage. If Reg IM projects are not aiming for or achieving these higher goals, they are falling short.
Adam Sherlock is Director, CSC Life Sciences and has extensive experience in the life sciences.
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Last updated on: 16/07/2012 11:29:28