THE HARD WAY - the pharmaceutical industry has yet to make serious headway with efficient, formalised regulatory information management (Reg IM), according to a new survey.
Author: Adam Sherlock, Director, Regulatory Solutions Group, CSC Life Sciences, a provider of regulatory software and services for the Life Sciences industry. asherlock2@csc.com, www.csc.com
Despite inescapable compliance requirements, the pharmaceutical industry has yet to make serious headway with efficient, formalised regulatory information management (Reg IM), according to a new survey. This isn’t only a worry from a regulatory perspective, but also a sign that companies are working harder than they need to to derive commercial advantage from the data they record each day, says Adam Sherlock, director at CSC Life Science
Startling new research has found that just 20% of pharma companies have fully implemented a formal strategy for regulatory information management (Reg IM) - despite pressure from the authorities to abide by new rules governing data capture, tracking and submissions. 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. 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.
Low adoption
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 – not least 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.
Myopia
It appears companies are still short on imagination about the broader benefits of formalising regulatory IM too, 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; by contrast 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.
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. Awareness of the broader advantages of a joined-up, automated data management environment should help boost employee buy-in to new processes and systems, because ultimately these will make people’s lives easier and their jobs more rewarding.
Knowing your limits
It is understandable that life sciences organisations won’t 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.
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 systematically, strategic opportunities for the different parts of the business are unlimited.
18th July 2012
Author: Adam Sherlock - Brief bio
Adam Sherlock is Director, Regulatory Solutions Group, CSC Life Sciences, a provider of regulatory software and services for the Life Sciences industry. Email asherlock2@csc.com, www.csc.com
