In today’s complex regulatory environment, pharmaceutical, biotech and medical technology companies are facing increasing pressure. They must comply with evolving regulations and requirements, and keep costs in check, all while maintaining a laser-like focus on improving patient outcomes.
Historically, companies have had limited access to data or data has come from disparate sources that are distributed across numerous legacy systems. But for companies looking to invest in technology and/or partner to improve their technological capabilities, we see five trends having far-reaching effects across the industry.
Master data management that prioritizes validity and sustainability
With master data management, we’re seeing a move away from uncontrolled data spread across a large landscape of systems to data that's easily accessible and verifiable. Depending on the size of the organization, companies are undertaking various activities, including:
Analyzing existing systems and processes;
Performing data cleanup and consolidation;
Implementing a new system to manage the data; and/or
Moving from a manual system that relies on spreadsheets or other simple document formats to a more robust and sustainable process.
Master data management and regulatory information management (RIM) systems offer companies a range of benefits, from a single source of truth and simplified processes across systems, to standardized terms and data that is verifiable and validated. This can ease the strain of tracking clinical trials and regulatory submissions, provide systematic workflows, improve regulatory compliance and enable better collaboration with health authorities and other partners.
Improved access to information through structured data and content management
Regulatory agencies are starting to push for structured data in regulatory submissions and clinical trials. The European Medicines Agency, for example, is in the process of implementing standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). And the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is working with regulatory authorities and the pharmaceutical industry to achieve greater harmonization and standardization.
At the recent Regulatory Submissions, Information, and Document Management (RSIDM) Forum, representatives of the FDA and Health Canada mentioned moving toward more structured data and content, with a vision of future regulatory submissions being in truly electronic form rather than PDF documents. For life sciences companies, these changes will simplify submissions and speed up the approvals process.
Automated data extraction and translation
Along with structured content, we see the industry making more use of automated data extraction. Regulatory agencies will extract data from fillable forms, scan data submissions and translate information for analysis. This will enable them to automatically route submissions to the appropriate review group, or even notify drug manufacturers and the public about concerns or availability of drugs or ingredients. The more that data is accessible and the better the analytics tools, the easier it will be to identify larger-scale safety trends.
A leap forward in natural language processing
Huge strides have been made in natural language processing over the last several years, with a focus on analyzing language for context and meaning. In the near future, we expect to see automation and natural language processing combined. This will enable companies submitting drugs in multiple markets to update labeling and marketing materials, including translated versions, more quickly and with greater precision.
The use of artificial intelligence for predictive analytics and business intelligence
Artificial intelligence (AI) algorithms will also have a huge impact, not just with natural language processing, but by enabling companies to make predictions about required changes based on variations in drug formulas or ingredients. Another exciting advance will be in our ability to apply AI in situations with direct impacts on public health, such as anticipating the most appropriate flu strains when developing flu vaccines and responding quickly to the spread of infectious diseases such as Ebola, to more effectively mobilize volunteers and therapies to quarantine and stop an outbreak.
These five trends will contribute to the ongoing transformation of the life sciences industry, enhancing product labeling, enabling better compliance and collaboration with health authorities, offering end-to-end visibility into regulatory activities, speeding up the time to market for new medicines and devices, and—most importantly—improving the lives of patients.