At a glance
Biotech and pharmaceutical companies face unprecedented pressure to maintain margins in an environment of increasing regulation and heightened competition. Any process improvement that can expedite time-to-market for new therapies lets manufacturers start earning revenue sooner and gain a competitive advantage.
One of the world’s leading biotech companies recognized that inefficiencies in their protocol authoring procedures were slowing down clinical trials, leading to costly delays in the release of new therapies.
Our client had received a large number of complaints from employees regarding the slow pace and inefficiency of their protocol authoring procedures. Numerous stakeholders who had come over from competitors had commented that the process was overly bureaucratized and took far longer than it did at other organizations. The research team had expressed frustration with the slow pace of approvals, noting that they frequently needed to “go around” the system just to get their work done.
Our client recognized that if they were to keep pace with the demands of the market, the delays caused by their current protocol procedures needed to be addressed. They needed help identifying specific causes of delay and streamlining the process to shorten their overall time-to-market.
The client also faced a knowledge gap concerning process improvement methodology. They needed an approach that would take into account the group’s current level of understanding and educate them along the way.
Approach and solution
The client chose Logic20/20 based on our track record of success in working with other healthcare clients, as well as our background in process improvement and specifically in lean methodologies. They also knew that we had worked successfully with clients with low process maturity and that we could guide their teams through the complexities of process change.
Logic20/20’s approach to the problem entailed employing lean facilitation, baselining the process, identifying process waste, and defining defects. Taking into account the organization’s maturity level around process improvement, we set up the program in a way that allowed us to provide the appropriate levels of foundational education as we progressed.
Our first step was to document our client’s protocol authoring process from start to finish. To ensure an accurate understanding, we conducted a series of workshops, each involving 8–10 members of our client’s R&D and operations teams. We mapped out the process and identified numerous inefficiencies, including
- Too many reviews with too many stakeholders
- Lack of standards around processes, people, and tools
- A large quantity of researchers’ time spent on non-science work
We then developed a strategic plan for eliminating unnecessary checks and balances and implementing a simplified protocol authoring system. We helped our client develop a streamlined procedure that
- Limits the number of reviewers and review stages
- Standardizes project management standards, tools, and templates
- Gives researchers greater autonomy in making decisions
Value and benefits – “the wins”
This project has identified methods for researchers to spend less time revising protocols and more time on R&D, with the potential for our client to shorten their overall time-to-market for new products by up to 12 months.