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Description: Many people choose a career in the healthcare or pharmaceutical research to save and improve lives. Over the course of a year, we are implementing process improvements to the clinical trial lifecycle. The end result will save tens of thousands of additional lives and help the company realize additional hundreds of million of dollars.

In the pharmaceutical industry, the costs of new drug design and discovery, combined with the expense of taking a new product to market, can easily run into the hundreds of millions of dollars. Organizations that can shorten their time-to-market window, even by a small percentage, are poised to save millions — not to mention saving or improving hundreds or even thousands of patients’ lives.

One of the most time- and resource-consuming aspects of new drug development is the clinical trial stage, which involves numerous departments and takes years to complete. Any time-saving improvements to clinical trial processes can help organizations get their drugs to market faster, which reduces costs, creates a competitive advantage, and enables them to help more patients sooner.

Our teams are working with one of the world’s leading biotech companies to implement process improvement strategies in two key phases of the clinical trial process: the creation of study protocols and the execution of the study itself.

The Challenge

Before entering the clinical trial phase of drug discovery, teams must build out a study design, called a protocol, which describes how the trial will be conducted, including objectives, design, methodology, statistical consideration, and overall organization.

The protocol rolls into the operational plans and activities that must be performed during the study, which can include processes for opening test sites, recruiting patients, and conducting and closing out the study.

Our client has noticed roadblocks to decision-making in their protocol creation process that are causing significant delays. In addition, processes currently require a significant time-spend on document creation, pulling researchers and clinicians away from their focus on the science. Approaches to protocol writing vary from team to team, depending on the people and skills available at the time, resulting in inconsistent output and frequent rewrites.

The Solution

Our teams will streamline the study design and execution phases to reduce our client’s overall time to market. We are working across the organization with the business, science, and operations teams. By design, our lean team requires minimal time from the science team; our goal is to keep the focus on drug discovery.

By revamping how clinical protocols are authored and executed; we’re taking the client to being near the top in their industry. We’ll be improving the study design workstream by formalizing the writing processes and restructuring how teams author and collaborate. Our team is focusing on lean study design to drive efficiencies and process improvements.

Additionally, we’ll develop an end-to-end study plan that includes study start-up, trial, and closeout to drive time savings and coordination. During this process, we’ll identify pain points and develop the solution to create a high-level future state design.

We will partner with our client’s project teams to:

• 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

Once we’ve designed the process improvement strategy, we will go on to create training materials, including the plan outline and supporting documentation.  

The Result

By shortening the clinical trial lifecycle by upwards of six months per clinical trial, this solution that will save tens of thousands of lives over the next several years. The project has a direct and significant impact on the firm’s bottom line and will help our client realize hundreds of millions of dollars in additional revenue over the next several years.

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