With the advent of significant new regulatory requirements, such as IDMP, and the continuing recognition that regulatory information is a largely underutilized corporate asset, we see four promising emerging technology areas as relevant to world class management of regulatory information.
1. Master Data Management (MDM)
It is widely recognized that establishing and using data and document standards across regulatory systems and within systems that contribute to regulatory systems helps ensure regulatory information is more useful and accessible.
In the past, there have been major obstacles to establishing formal regulatory master data management programs. Regulatory groups believed that their systems, process and data met their minimum needs and typically were frustrated by the existence of so many “niche” systems and the cost of integrating these systems. As long as regulatory requirements were met and the company was compliant, even if it sacrificed cost and efficiency, it was “acceptable”. IDMP and UDI are changing the thinking with between 50% – 66% looking to adopt a MDM approach.
Our 2016 survey demonstrates that efficiency of various key regulatory capabilities is very low across the industry (see Exhibit 11), only one regulatory capability (submission production) has a “ok” efficiency rating with the overall study average at only 39%.
We now see an increase in the recognition that efficiency as well as effectiveness is important as new internal and external requirements are identified. A key external requirement is to submit IDMP data for marketed and investigational products, and structured substance information over the next few years. IDMP data source and data quality analyses have shown that meeting IDMP submission requirements will be a multi-year, multimillion dollar effort for mid-size and large biopharmaceutical companies in part due to the need to assemble data from multiple sources within regulatory and non- regulatory areas, such as safety, clinical and manufacturing.
More efficient regulatory information management built on improved data standards, standard processes and true authoritative source identification is emerging as a critical need spurring the re- evaluation of enterprise MDM programs and governance. We also believe that a master data management approach is more cost effective over a 5 – 7-year total cost of ownership period.
2. Business Process Management (BPM)
Some companies are investing in BPM solutions to support standardized business process execution and to simplify the use of complex regulatory software systems. In the last few years, we identified the need to simplify the use of technology for infrequent users of systems. A common complaint is the need to understand a fairly complex user interface and drill down several screens to enter one simple regulatory transaction e.g. a country gains product approval from the local health authority and wants to update the product registration system where the registration status is contained and scan in the approval letter to the submission content management system. This becomes a time consuming transaction in two large and complex systems. This is why some affiliates struggle with compliance and timely data entry.
BPM systems that can fully understand each business process step and context, and provide an easy way to access the specific field in the underlying RIM system could provide significant improvement in timeliness and quality of data in RIM systems.
3. Software as a Service (SaaS) / Cloud ComputingWe have been tracking the interest and adoption of SaaS for regulatory capabilities since 2011. Our data show that while there is significant interest in adopting a SaaS solution for many of the common RIM capabilities, there has been relatively little actual SaaS implementation. The low adoption rate, especially compared to other industries and to some non-regulatory functions in pharma, is likely due to a complex mix of factors including, but not limited to:
- Concerns about data security
- Uncertain ability to meet regulatory inspection criteria
- Lack of evidence of success of peer regulatory groups
- Concern the current system, data and business process environment is not sufficiently mature to be moved to a SaaS environment
However, lessons from other industries and other functional areas in life sciences show that solutions can be implemented faster, made globally accessible and can often be operated at less overall cost than internally provisioned solutions.
In addition, the data and process standardization that is typically part of global SaaS deployments is likely to lead to significantly better global access to the authoritative source of regulatory data.
Our 2016 survey data (Exhibit 12) shows a significant increase in electronic Trial Master File SaaS implementations since 2014. We are tracking this closely to see if it will carry over to the highly integrated RIM capabilities.
4. Artificial Intelligence
Several IDMP data source and data quality analyses conclude that at least 50% of the data needed to meet the current IDMP reporting requirement is located in unstructured documents and reports. Some of this data is unique to the source and some is potentially duplicative or conflicts with other sources. A key emerging requirement is to efficiently and effectively locate the specific data in unstructured sources. The data must then be extracted or, as a minimum, highlighted for evaluation.
Software solutions from other industries, such as the intelligence and legal e-discovery communities, are being investigated to determine if unstructured sources can be mined for IDMP data. These solutions use advanced mathematical methods to identify contextual meaning and relationships of text in unstructured documents without the requirement of coded keywords or pre-established dictionaries.
While these tools are in the early evaluation and proof of concept stage, further analysis and development could provide a very useful service in analysis of unstructured data sources for IDMP and more broadly in regulatory information management search and reporting.
We believe there will be a continuing development and adoption of new technology over the coming years, especially in the search for more efficient regulatory information management methods and practices.