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May 16, 2019

The Challenge

Pharma industry today faces a complex challenge when it comes to managing regulatory information for a product life cycle. The complexity is borne out of the quantum of disconnected information stored in disparate systems backed by software solutions that do not integrate well with each other.

With the expansion of emerging markets, multiple stakeholders, changing local and regional regulatory requirements, and evolving compliance needs, the complexity has grown multifold. Process dependencies, iterations, and rework has added to the inefficiency of the processes and resulted in delayed submissions, and in turn late market launch for drugs. It is no surprise, pharma companies are struggling with streamlining of regulatory information management (RIM) framework.

Based on the business and IT strategies, budgets, and leadership buy-in of the pharma companies, different firms are focusing and adopting varied phased-approaches to make RIM more efficient. The current focus is on the transformation of regulatory IT landscape including consolidating and changing the silo systems into a single integrated platform. In addition, the intent is to simplify and add flexibility to systems with interoperability, as well as ensure a holistic view of regulatory information from product discovery to launch. This in turn should help drive compliance needs while ensuring operational efficiency, productivity and visibility.

Levers to Modernize RIM:

In a bid to achieve increased regulatory operational efficiency with reduced cost and time, following key levers are essential to modernize RIM going forward:

  • Simplification: Simplification of processes and IT landscape has gained traction as a key element to achieving operational efficiency. Opportunities for improvement across regulatory information management processes (e.g. submission) by virtue of metrics and lean methodologies (value stream mapping) are current focus for most of the organizations. Enforcement of standardization for identification of medicinal products (IDMP), clinical trial registration initiative (CTRI), electronic common technical document (eCTD), and fast health information resources (FHIR) are some modes for simplification.
  • Digitization: RIM has started adopting digital technologies to manage data and documents in a more structured manner. It is possible to digitally-monitor record management, collaborate, exchange information and have end-to-end traceability of regulatory events. In addition, digital technologies embracing block chain, master data management, and advanced analytics have transformed current operations.
  • Automation: For manual, repetitive, time-consuming, and quality intensive processes, automation is a real game changer for transformation of RIM. Right from the correct capturing of events, triggering action, down to automating the entire processes via management of workflows, notifications and record updates can be streamlined using various automation technologies like Robotic Process Automation (RPA), cognitive and deep machine learning (NLP, ML, and & AI), hence transforming regulatory operational  efficiency , quality and compliance.
  • Advanced Analytics: By embracing AI-backed analytics, pharma companies are now able to look for insights to build regulatory strategies for submission approval, early drug launch practices, and take well-informed regulatory decisions.
  • Business Intelligence: For strategic and operational reporting needs, it is essential to have visibility across regulatory functions, interdependent processes, and increased interactions with internal and external stakeholders as well as regional and local affiliates. Strategically, global regulatory affairs within organizations have to support portfolio registrations, safety report submissions, clinical operations, and variation management. By leveraging business intelligence capabilities across regulatory functions, organizations can achieve greater operational efficiency, as well as accurate analytics and insights to make better decisions.
  • Collaboration: As new working models come into use, the interfaces with regulatory internal and external stakeholders has become more important. Moreover, with the new trend of outsourcing regulatory businesses, it is difficult to manage the partners dealing with information security issues. This has emphasized the importance of cloud-based collaborative platforms with automated workflows. These can enable better collaboration with partners/stakeholders like CROs, software vendors, affiliates, academia etc.

Given the pharmaceutical companies have to handle large volumes and a variety of data sets there is a growing need for simplified, secured, integrated, and interoperable platforms. These platforms will need to insure innovative technologies, automatic data integration, and metadata management capabilities. Additionally, collaborations are increasingly gaining popularity within the community on all counts including data sharing, as well as for better decision-making. In addition to increased adoption of agile and DevOps for faster and efficient delivery, pharma companies are exploring and leveraging various options to modernize and transform RIM.

Rita Shah is a Clinical Research professional with over 21 years of experience in academic research in the Life Sciences and Pharma domain. She is actively involved in research and development of innovative conceptual solutions leveraging automation technologies. Rita has a PhD in Organic Chemistry from Council of Scientific & Industrial Research (CSIR) and has more than a dozen research publications in peer reviewed journals. She has also worked as a Postdoctoral Fellow and Assistant Research Professor (Molecular Biology) at the Indiana University School of Medicine, USA.


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