At a glance

One of the world’s leading biotech companies set out to shrink their timeline for filing new products with the FDA and other agencies.

Customer challenge

In the highly competitive healthcare industry, delivering new products to market quickly is essential for staying ahead of the competition. Part of the go-to-market process involves compiling and submitting the paperwork for filing new products with the FDA and other agencies, which involves numerous departments and a series of internal procedures.

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.

Approach and solution

Logic20/20 had successfully completed a process improvement project for this client that optimized their protocol authoring procedures and expedited their time-to-market by up to 12 months. Having seen first-hand the results we deliver, they knew we were the right choice for this project.

We met with our client’s subject matter experts (SMEs) from around the world to map their existing clinical trial documentation process. In conducting these meetings and analyzing the outcomes, we identified numerous opportunities for improvement, including

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

After analyzing the process from beginning to end and validating our findings with the SMEs, we developed a series of solutions aimed at reducing the timeline, including the following:

• • Begin steps simultaneously if one is independent of the other, which sometimes requires adding resources.
• • 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.

Value and benefits - “the wins”

In shrinking the window for our client’s clinical trial documentation process, we helped them shorten their total go-to-market timeline by several months, creating a competitive advantage that could mean millions in additional revenues. Even more importantly, by speeding up the delivery of critical technologies to the patients who need them, we’re helping them save and improve more lives.