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Building IND Regulatory Systems:

A Recipe For Success Aligning People, Tools and Process

Utilizing company resources wisely will help your team stay the course when facing tight deadlines and rigid submission criteria.

As a regulatory leader at an emerging pharma company, the pressure to successfully bring a product to clinical trials is significant. There are countless hoops to jump through and, at times, you simply cannot see the light at the end of the tunnel. This challenge will be especially apparent if you have previously worked at larger organizations, with bigger teams and more infrastructure in place.

Irrespective of what led you here, you now find yourself stretched thin and working long hours, trying to maximize available resources as best you can. But meeting Regulatory Submission deadlines can be stressful—particularly initial CTAs (Clinical Trial Applications) and IND (Investigational New Drug) applications—and you worry you won’t get yours submitted on time and following regulations. After all, it’s your responsibility to ensure a timely and compliant submission and cutting corners simply won’t do!

Best practices will tell you to place considerable emphasis on determining which tasks your company should outsource versus which it ought to handle internally. However, while this is an important first step, it is possible and advisable to take this premise one step further to assess exactly how best to streamline various core aspects of your clinical trial application.

This deep dive approach involves optimizing the people, processes, and tools that your organization utilizes over the next 12 to 36 months. Once your team is able to get these three critical components into alignment, you’ll clear the path to starting clinical trials in a way that’s not only productive but also cost effective and fully compliant.

Keep team members productive and aligned using an effective delegation strategy.

Emerging pharma companies who successfully bring one or more products to clinical trial typically do so because they build simplified processes that align with their chosen tools. However, processes and tools are nothing without the people who use them. Therefore, an important starting point in creating a system that runs smoothly and helps your company succeed is... 

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