Streamlining regulatory submissions

By Ethan Smith, Director of Life Sciences Solutions, Metastorm

Ethan Smith explains how to automate submission document processes for strategic advantage.

“A common misconception is that BPM and content management are competing disciplines, which is absolutely false”
-Ethan Smith

Regulatory submissions are critical to every life sciences organisation. What does it mean to automate them?
ES. Given the fact that submission documents contain the content upon which regulatory agencies make decisions, recommendations and ultimately grant approvals, they are in fact one of the most - if not the most - important sets of documentation for every life sciences organisation. While this point is widely accepted, the processes by which these documents are produced, reviewed and approved before submission are not always well understood or documented and often depend heavily on manual intervention and heroics to meet submission deadlines, despite the fact that these deadlines are typically known many months in advance.

Automating the planning, writing, scientific review, quality assurance, approval and issuing processes using business process management (BPM) software entails web-enabling the work steps involved, capturing critical information about both the content and process logistics and then using this information as the basis for resource planning, performance metrics, and ultimately process improvement. There are several key benefits gained from a BPM solution, including timely access to and incorporation of clinical data, shortened review cycles, improved global resource management and productivity, and significant transaction cost savings. And ultimately, BPM enforces adherence to submission deadlines, which in turn contributes to strategic advantage.   

How does the automation of the submission document processes with BPM relate to content management solutions employed by life sciences companies?
ES. A common myth is that BPM and content management are competing disciplines - which is absolutely false. Content management is a competency and set of technologies that are complemented and extended through the utilisation of a BPM solution. With respect to submission document processes, the content management solution remains the secure, validated repository for controlled documents and associated content. The business processes for creating and processing said content and documents is what BPM handles - essentially providing a process wrapper around the validated content management repository.

By extracting the business process from the physical content artifacts, the business processes become much more agile and controllable by the business, without the risks and costs associated with custom changes to validated enterprise content management applications. Once the business processes have been defined, the BPM application can access controlled documents by way of hyperlinks to ensure the version control features are not altered while also providing business users immediate access to the working documents associated to a specific process in a seamless fashion. This approach takes advantage of the strengths of both technologies to empower the business to better manage and control the business processes and activities while simplifying the maintenance and management of the validated content management system for IT.

Globalisation is a key tenet of the life sciences regulatory environment today and is likely to become more important over time. How does BPM support globalisation?
ES. With the many challenges the industry faces today, globalisation is one of the key opportunities for life sciences companies in two major ways. With growing disease incidence and increased access to care in emerging markets, globalisation represents a key growth segment. At the same, rising cost pressures are forcing life sciences companies to look for ways to globalise their operations for sustainable operational cost reductions.

Automating submission document processes offers a unique way to take advantage of lower offshore resource costs while at the same time improving turnaround times for the submission documents. By virtue of the fact that the automated processes are accessible online, work items can be handled by any resource regardless of location with complete visibility to management. Not only does this allow companies to more effectively leverage offshore resources, but it also enables work items to 'follow the sun' and be worked on across time zones to maximise working hours in a 24-hour period. These two advantages make processes both faster and cheaper while at the same time providing management with clear visibility into where each document resides at any point in time and giving them the ability to reprioritise and reassign work with ease. BPM makes all of this is possible while still maintaining the content in the same validated repository where it has always been.

Ethan Smith sets the strategy for Metastorm's life sciences solutions globally. He has over 10 years of experience consulting to the industry and solving process-related problems to create tangible business value.