Customer Stories: Expediting regulatory filings through process improvement

2-minute read

In today’s highly competitive healthcare industry, organizations that can expedite time-to-market for new products place themselves at an advantage. Here’s how our process improvement experts helped one of the world’s leading biotech companies to streamline its clinical trial documentation process, resulting in significant time savings in bringing new products to market.

The Challenge

As part of the go-to-market process for new products, healthcare companies must document their clinical trials and file the paperwork with the FDA and other regulatory agencies. As this complex process involves numerous departments and a series of internal procedures, any improvements can help shorten overall time-to-market and make life-saving therapies available faster.

Our client’s existing process to compile and submit their clinical trial paperwork required 26 weeks, whereas some of their competitors only required 12. To preserve their competitive edge, our client set an ambitious goal of matching their competitors’ 12-week timeline, which required an end-to-end analysis and revision of their current process.

We had successfully completed a process improvement roadmap for this client that will optimize their protocol authoring procedures and expedite their time-to-market by up to six months. Having seen first-hand the results we deliver; they requested our help in expediting their filing process.

The Solution

Our first step was to meet with the client’s subject matter experts (SMEs) from around the world and create a detailed map of their existing clinical trial documentation process and specific pain points.

Using the data collected from these meetings, we identified numerous opportunities for improving the process, including

• Eliminating duplication of work
• Filling in the gaps between the end of one step and the beginning of the next
• Creating a real-time progress tracking system
• Removing unnecessary repetition of quality control (QC) processes
• Resolving disconnects between internal deadlines and the amount of work required to meet them

After analyzing the process from beginning to end and validating our finding with the SMEs, we applied process improvement strategies in developing recommendations for reducing the total timeline, including the following:

• Begin steps simultaneously if one is independent of the other, which sometimes requires adding resources.
• Automate repetitive tasks.
• Leverage existing data and content to pre-populate lengthy regulatory filings.
• Improve communications to keep the process moving.
• Standardize the QC process and eliminate unnecessary repetition.
• Implement data quality controls early in the process, where incomplete or faulty data can be corrected quickly and efficiently.
• Standardize the medical writing process and implement collaborative authoring between writers and scientists, which decreased the writing timeline from four weeks to two by reducing the need for edits and rewrites.

The Result

By streamlining our client’s clinical trial documentation process, we helped them shorten their total go-to-market timeline by a matter of months, giving them an edge over competitors that could mean millions in additional revenues. Even more importantly, we’re helping them save and improve more lives by expediting the delivery of critical technologies to the patients who need them.