Whitepaper: Specific RIMS upgrades as data-driven submissions ambitions grow

Although the regulators are providing guidance around the data submission requirements in an iterative manner, the companies should consider getting their RIM system configurations upgraded, existing data remediated, processes optimized and data quality and governance functions in place now, instead of awaiting final requirements to be shared by the health authorities.

Life Sciences industry regulators have become increasingly focused on data-driven submission processes as a means of managing marketing authorization submissions. A raft of new and updated standards has created new impetus for drug and device companies to tighten up and broaden their regulatory information management across the product development lifecycle as a matter of strategic importance.

Potential associated benefits to companies themselves, of embracing enhanced process and data quality rigor is a cornerstone to support data-driven processes, include

• improved trust in data to suggest essential decision-making;
• tighter integration of core data with business processes and reporting;
• optimized/accelerated health authority interactions;
• increased regulatory intelligence;
• streamlined data exchange between business functions.

Holistic approach

Effective initiatives will involve a rethink not only of current system capabilities, but also of the processes involved in capturing, managing and using the richer data reserves that companies should consider now building.
The more that original data (rather than compiled documents) becomes the foundation for submissions and associated regulatory exchanges, and to inform internal decisions, the more robust and reliable the quality, and completeness of that data needs to be. This means regulatory information management system (RIMS) upgrades should be approached holistically, and not just as a technology-specific project.

This paper sets out some of the associated challenges that can emerge as companies tackle their RIM solution upgrades and provides targeted considerations for getting ahead and effectively realizing the fuller business benefits of a well-rounded, data-driven RIM capability.

Authors

Oliver Steck
Partner Deloitte US

Adnan Jamil
Manager Iperion, a Deloitte business

Arushi Kumar
Manager Deloitte US
Risk & Financial Advisory practice