Regulatory Information Management as a Strategic Asset

Gens and Associates confirms that trend. Regulatory information management (RIM) has become a major focus among pharmaceutical companies. Industry analysts observe that companies are viewing RIM more strategically and seeking to optimise their operational capabilities. And a recent RIM survey from Gens and Associates confirms that trend. 

Data from the Gens 2014 survey- Next Generation Regulatory Information Management and Intelligence: Strategy, Investments, and Status-shows that 60% of surveyed companies view RIM as a strategic asset. RIM’s tactical value in terms of supporting regulatory operations remains as important as ever, but companies are now looking to get greater value from their solutions.

Ultimately, the reason can be attributed to three overarching drivers. The first piece of the puzzle is capability: pharmaceutical companies need to find ways of obtaining and maintaining approvals for their products in the most efficient way possible. The second driver is capacity: companies need to ensure their products are managed successfully in all countries where they operate and that they make the most of data to expand their portfolios and market shares. And third, both of those challenges play out in an economic environment where heads of business require R&D to do more with lower head counts.

Managing those complexities requires companies to improve their processes and increase their efficiencies, which puts them under huge pressure to simplify the management of their R&D data. That’s no easy task, because the owners of the data in even small to midsize companies could be dispersed anywhere in the world and across multiple functions.

Exploring the Data

In the weeks since the survey closed, Steve Gens and his colleagues have been assessing the data and determining trends and industry sore points, as well as separating from other survey participants the top-performing companies in terms of RIM efficiencies.

In total, 41 companies participated in the 2014 survey, spanning small, midtier, and large pharma companies. Delving into the data, Gens found seven companies that stand out from the rest. These Super 7 consist of four large pharma companies and three midtier companies.

The difference between the seven standout companies and their peers is apparent from project inception. Any significant project requires certain key parameters, such as support from the executive office, establishment of project goals and expectations, and ongoing communication. Deeper analysis of the survey data found that the Super 7 report 86% executive sponsorship compared with 47% for the rest of the respondents; 71% are successful in setting expectations compared with 41% that are not; and 71% ensure ongoing communication planning versus a disappointingly low, 26% at the 34 other companies.

Survey participants stressed several priorities for their RIM solutions: (1) they want their affiliate companies to be able to participate in global RIM initiatives; (2) outsourcing is now routine practice and starting to spread into areas once considered out-of-bounds-for example, New Drug Applications; and (3) most companies are undertaking gap analysis and planning for the Identification of Medicinal Products (IDMP), although Europe-headquartered companies are perhaps taking more-strategic and longer-term approaches.

The Affiliate Journey

There is significant emphasis across the board on improving the ways information gets exchanged and shared with the central regional and local affiliate offices. Almost across the board, pharmaceutical companies are eager to both (1) achieve global authoritative sources of information to help improve how information gets shared with and by affiliates and (2) improve global communication. In fact, 91% of companies say collaboration between the central regulatory office and local affiliates is either improving or a target for improvement. And improving the ability of the affiliate office to enter and access regulatory information was cited as a top priority or important by close to 100% of respondents.

Deeper analysis of the data shows that the Super 7 companies have implemented global RIM systems and have participation by at least 75% of affiliate offices. Those companies have higher affiliate participation in registration, labeling, document management, health authority correspondence, and regulatory-knowledge management capabilities. It is noteworthy that publishing is almost nonexistent at the local level, where either the regional or central offices support this activity or the activity is part of a broader business-process-outsourcing programme.

Outsourcing Imperative

The survey also finds that the outsourcing of regulatory activity-everything involving either achieving approval for a medicine or maintaining the medicine on the market in terms of regulatory-is now regarded as normal practice.

According to the Gens survey, 57% of companies outsource small maintenance submissions - that is, the life-cycle maintenance of legacy products - and that figure is predicted to become 74% in the next year or two. Those percentages are much the same for the outsourcing of affiliate marketing submissions.

Data from the survey indicates a big shift in the evolution of the outsourcing of regulated activities during the past five or six years. Just two years ago, most companies were simply undertaking very functional outsourcing of specific types of tasks and activities. Moving to a point where companies are taking the life cycle of a regulatory activity across safety, maintenance, quality, manufacturing, and indeed all of the different business functions and processes and turning that life cycle over to a partner suggests a seismic change in the industry.

In the early days of regulatory outsourcing, the goal was simply cost reduction, but today companies are turning to partners for assistance with organisational head count and workload levels. In further analysis, Gens and Associates found substantially higher cost reductions in dossier outsourcing at the Super 7 than at their peers-86% compared with 25%-as well as much higher success rates in efficiency and overall quality. This would imply stronger strategic relationships, and in fact the Super 7 do state better overall satisfaction with their RIM solution providers.

Tactical or Strategic: IDMP

The impending IDMP data standards-due to come into force in July 2016-have earned plenty of industry attention. The survey shows that close to 70% of companies were expected to have developed their IDMP strategy by the end of 2014, and leading industry consultant Andrew Marr says that that figure is consistent with other anecdotal findings.

Marr notes, however, that many challenges lie ahead, including (1) putting strong internal strategies and policies in place and (2) getting ready to manage the impact of the implementation guides once the guides become available. Consideration also needs to be given to (1) the way the IDMP will link in with internal master data management programmes and architectures, (2) ensuring a budget for cross-functional systems, and (3) convincing management not to leave the strategies to the last minute.

Another troubling survey finding is that participation in the IDMP by some departments is quite low. For example, 49% of respondents say manufacturing and supply chain are participating in IDMP requirements analysis. However, Marr says, because IDMP pushes significantly into aspects of manufacturing, technical operations, and chemistry, manufacturing, and control regulatory, those functions should participate more.

Overcoming Inefficiencies

In its 2014 survey, Gens and Associates included several questions on efficiency, expanding from the focus on the effectiveness of RIM capabilities. What the survey found is that although having effective compliance in place is critical, improving efficiency is seen as a priority.

Companies are now concerned not only with meeting their regulatory obligations but also with improving their business processes and productivity across the global enterprise. However, efficiency gaps remain. Although companies are starting to become more efficient in areas that have been fundamental to even the earliest RIM solutions-publishing, R&D document management, and safety reporting-inefficiency remains in many other parts of the business.

Companies across the board are keenly focused on improving efficiency levels in those other business parts-particularly at the key touch points between regulatory and manufacturing change control and product supply release. In fact, just 18 months ago, only 35% of companies were working to streamline those touch points, whereas now 88% cite such improvement as a pressing need.

In further analysing the data, Gens finds that the difference between the high-performing companies and the rest of the survey participants is quite significant. What may be most surprising is that in the three most established areas-publishing, R&D document management, and safety reporting-the Super 7 are close to 100% efficient, whereas many other companies are average in their efficiency ratings. And in the areas of dossier management, product registration, and submission planning, the difference is noteworthy, with the high performers at around 70% efficiency and the other companies at less than 40% efficiency.

But across the board, areas such as labelling and translation management remain highly inefficient, and having an integrated view to report analytics remains a sore spot for the majority of companies.

A Progressive Strategy

Companies are feeling immense pressure to improve collaboration with affiliate offices, achieve an authoritative source of information-often referred to by companies as a single source of truth-and enhance data quality.

Next-generation RIM solutions and strategies will need to more closely heed those requirements while responding to changing data standards-in particular, the IDMP. As Marr has stressed in IDMP discussions, taking a strategic approach to the standards presents an opportunity to establish a single, authoritative source of data for multiple purposes. And in so doing, companies gather insights, improve the quality of their data, and gain greater efficiencies across the business. 

About the Author

Adam Sherlock (asherlock@productlife-group.com) is CEO of ProductLife Group.