Supporting the Future of RIM

By Caroline Masterman-Smith, Senior Manager of Technology & Innovation at Kinapse and Aatif Kababi, Consulting Manager at Kinapse

Regulatory operations has significantly evolved in the past few decades. From collating, managing, and publishing terabytes of data in the printed paper form to using state of the art systems for consolidating and publishing outputs in just a few clicks. Regulatory operations has transformed into a smarter function.

We believe there are three major contributors to this change. The first one is the evolution of regulatory requirements like eCTD, xEVMPD, and IDMP, which harmonize information management practices within the industry. The second factor is increasing pressure to find more efficient operating models and smarter ways of working due to rising lifecycle management burdens and shrinking budgets. The third factor is the maturation of cloud-native and digital technologies, which transform regulatory process and drive efficient operations. With the dawn of end-to-end solutions like Veeva Vault RIM, pharma companies can now unify regulatory data and content, enter data only once, and make critical, seamless cross-functional connections to quality, clinical, and safety.

However, regulatory functions are still struggling to realize the full benefits from these multi-year, multi-million dollar transformations. While smarter technologies like Veeva Vault RIM can help improve operations, it is still critical that regulatory operations groups utilize their functionalities in a way that is specific for their organizations. The most important success factor for any organization deploying these new cloud-native or digital solutions is to embrace the opportunity to standardize and simplify business processes and operating models. By doing so they can dramatically improve the global user experience and achieve greater business benefits. At Kinapse, we understand that people, process, and technology need to co-evolve for successful operations and benefit realization.

Companies need to develop smarter and simpler operating models to realize system and process efficiencies. They should focus on end user experience and develop human-centered applications that are intuitive and smart. Their operating models must simplify human-technology interaction and improve confidence in system data quality. Companies also need to clearly define their organizational roles and structures to efficiently execute regulatory processes.

User acceptance and buy-in are also critical elements for successful transformations, and involving the end users throughout the transformation is key. Companies need to think about smarter and more digital ways to engage with their user community, especially when it comes to change management and communications. This may feel like a lot of work upfront, but it significantly pays off in the long run.

The biggest arguments for embarking on extensive RIM transformation are usually process efficiencies and productivity gains. However, organizations need to realize that merely replacing systems will not take away all pain points. Until a few years ago, regulatory discussions focused on capabilities (e.g. document management, registrations management, etc.) and most vendors sold capability-focused solutions to clients. Now, we’re seeing companies and software vendors shift to a process-centric view and end-to-end solutions, like Veeva Vault RIM, are leading the way. The onus is on companies to stop looking at individual capabilities, data, or content, and take a holistic view of these technologies to understand how they can use them to manage day-to-day processes. A smart and innovative technology solution combined with well-defined processes and good quality data can significantly reduce costs and improve efficiency by up to 30%.

Another challenge for companies is underestimating the data migration effort. Companies often assume that they can extract data from their current systems and it will automatically match up with the new system. What they may not realize is that they need to establish a thorough data migration strategy and cleansing process before the actual data migration. This is a significant business effort, often requiring months, and must be incorporated in the plan.

Companies need to embrace innovation and technology to further improve user experience and simplify processes. While other industries like e-commerce, aviation, and banking were quick to implement digital solutions, the pharmaceutical industry lagged behind. This can be attributed to several factors, among them being an overly complex approach to validation. It is time for the industry to think more rationally and start questioning the value of complex validation cycles and reviews in light of cloud-based, pre-validated suite solutions like Veeva Vault RIM. It is also important to explore and embrace other digital solutions that may improve business processes and complement Veeva Vault RIM. For example, companies are beginning to challenge the binary concept of onshore vs. offshore resourcing. Companies should look for automation within Veeva and beyond to reduce cycle times, improve efficiency, and reduce costs. It is important for companies to start thinking about these digital technologies as real solutions and use them to simplify operations.

Lastly, it is also important for the bigger community – pharma companies, vendors and consultants –to think more broadly about R&D. Developing strong, end-to-end RIM capabilities is only the first step towards enterprise-level process harmonization where information can freely move between clinical, quality, regulatory, and medical functions. We all look forward to the day when a drug product is defined in regulatory in exactly the same way as it’s defined in clinical, supply chain, manufacturing, or quality!

To hear more about how Kinapse is supporting the future of RIM, join our session from 3:45-4:30pm ET on September 9, 2019 at the Veeva R&D Summit.