Quality IT

Clinical quality systems and processes aren’t
equipped to support commercial volume

Robust quality management platforms will drive manufacturing readiness and audit-preparedness in ways that spreadsheets cannot

At Project Outlier, we’ll partner with you to determine the right technologies to invest in, at the right time, to prepare your organization to scale.

As early as Phase 2 trials, we’ll develop a comprehensive IT quality strategy and roadmap that outlines the systems needed to drive commercial quality, such as quality event management and electronic document management systems, predictive quality solutions, and any integrations needed to support end to end workflows
We’ll determine the timing and sequence in which to implement these capabilities, ensuring you invest in the right solutions at the right times without blowing your budget

In accordance with your IT quality strategy and roadmap, we’ll help you select the specific technology platforms that are best suited to your organization’s needs
We’ll translate the roadmap into detailed implementation plans and will onboard the resources needed to deliver each solution
We’ll manage the implementations from start to finish and will oversee the IT quality roadmap as a whole
Where appropriate, we will leverage automation to streamline administrative portfolio, program and project management activities, enabling both efficient and effective delivery

We’ll ensure your quality systems go live before you receive NDA / BLA approval so you can confidently know that your systems are working as expected prior to launch
After go-live, we’ll provide ongoing training and support to maximize end user adoption
As part of ensuring IT quality readiness, we will also onboard managed services vendors to support and administer your new IT quality ecosystem

In collaboration with IT, we will finalize and oversee the post-launch IT quality roadmap to scale and improve your quality tech stack as the business matures
Plus, we will oversee managed services vendors to ensure your systems receive ample suppor

Clients Love Us Because We Help Them Deliver

Mary Echevarria

Senior Director, Global HR

You all have a lot to be proud of. We said it wouldn’t be easy, but you delivered above and beyond expectations. I am standing up and clapping very loudly.

Doug Walker

Senior Vice President, IT

Project Outlier is known to get things done—if you have a critical IT project that needs to get done, they will bring in high-quality talent that will organize and plan the work, drive the work to completion, and gain the respect of your peers along the way. When given the choice, I always use Project Outlier to get my IT projects done.

Gudrun Finn

Vice President IT

Project Outlier is my preferred vendor for project management and continuous improvement services. They deliver high-quality services on-time, within scope, and on-budget, every time, adeptly communicate across organizational levels, employ creativity, and resourcefulness to address challenges, and demonstrate foresight to mitigate risks proactively. Project Outlier resources are trustworthy, skilled, and positive.