Chuck Williams – IQVIA

For any pharmaceutical company setting up a clinical trial, the amount of regulatory paperwork to be signed and filed can be daunting. The time-consuming and manual process can easily take 100 days or more.

But that will no longer be the case with what IQVIA’s developing, according to IT Director Chuck Williams in Boston.

Innovations to step up the pace and create efficiencies in the legal documentation process are well underway with development of IQVIA’s new cloud-based platform. Soon, everything from patient consent forms to clinical trial contracts will be updated, authorized and managed through an automated process. Following the initial deployment scheduled for this fall and a subsequent release in the spring, pharmaceutical companies and research sites worldwide can expect to see an improvement in the contract template authoring and negotiation process.

“Until now, this process was largely done manually, so the goal of this project is to compress the time it takes to onboard a site into a study by 25 percent,” Williams says. “That’s truly significant. Multiply that by the number of companies and the numbers of studies and it’s easy to see that this will save our customers millions, if not billions of dollars.”

Log jam

Formed through the merger of IMS Health and Quintiles, IQVIA is a leading global provider of advanced analytics, technology solutions and contract research services for the life sciences industry. IQVIA is also a global leader in protecting individual patient privacy. More than 65,000 employees are carrying out its work in 100 countries.

Williams came into the mix in 2018 as a team lead following IQVIA’s acquisition of DrugDev in 2017. In 2019 he started his current role as IT Director/Cross-Functional Architect as part of the IQVIA Technology team.

The need to streamline contract processing was acute, he says. Biotech, medical device and pharmaceutical companies, medical researchers, government agencies and other health care stakeholders needed help getting clinical trials up and running fast. What’s more, he says they needed technology to better manage all aspects of their paperwork and contracts.

With signatures required on everything—from consent forms to drug protocol information to payment structures—studies couldn’t get underway without the proper documentation, and that was resulting in significant backlogs.

Chuck Williams, IT Director

If at first you don’t succeed, …

As Williams tells it, since 2007 there have been five attempts to create the platform.

“Initial attempts failed, but we didn’t give up,” adding that the project was reinvigorated with the 2017 acquisition. “We drew from past experiences and starting using prior information as base code, allowing us to morph the platform into serving the purpose we originally envisioned. It now allows anyone to author any type of document in the trial management process.”

Now known commercially as “IQVIA’s Clinical Document Architect,” the initial version came to fruition in the fall of 2019, with updates ongoing.

“IQVIA’s Clinical Document Architect is part of a platform that is a one-stop shop for everything needed for clinical drug trial management on a software as a service (SaaS) platform. Users will not have to go to multiple systems and worry about things like data integrity or managing the end to end lifecycle of every project,” he says.

Project timelines

With a working concept in hand, IQVIA added 13 staff to the project in April 2019; the goal being to bring the project to the finish line by fall.

With the initial release underway, user acceptance testing started in early November. Williams—who is serving as the cross-functional architect for the project—will continue to oversee testing and validation. A general release is slated for March 2020, once the testing is successfully completed.

Entrepreneurs working on laptop in creative office space

“At this point we are fine-tuning the platform and making it work as seamlessly as possible,” he says.

By March of 2020, Williams will oversee a second release of the active platform supporting the use of the technology in formal live clinical trials.

“This will all be done with real-life circumstances,” he says. “It is our expectation that we will be able to offer this capability on a broader scale to the industry in the second quarter of 2020.”

One process, many different applications

The beauty and economy of the cloud-based platform, Williams says, is that it doesn’t matter which documents need to be signed or authorized: the platform can be easily adjusted to handle them all.

The platform is made possible with the use of Amazon Web Services (AWS), an innovative comprehensive cloud platform for health care and life science organizations. With more than 100 HIPAA-eligible services; advanced machine learning and analytics tools that are simple to build and deploy; and data interoperability frameworks, IQVIA is able to leverage AWS’ capabilities to create a digital clinical trial platform that is working to improve patient experiences and health outcomes.

“This will streamline countless aspects of the clinical document authoring process, adding value every step of the way,” he says. “We will continue to build on our success. Our goal is to be the de facto platform for clinical drug trial management.

Playing to his strong suit

If there’s anything that has contributed to Williams’ success—particularly for a project like this—it would be his penchant for enterprise application integration and his strength in business process automation, he explains.

Williams got his start perfecting those skills by earning a bachelor’s degree in computer science and music at Dickinson College in 1984.

Since his graduation, he’s immersed himself in a career chock-full of technological jobs, many of them in the Boston area.

“I enjoy solving the unique problems such a platform presents,” Williams says. “It wasn’t built from a single source; its development expanded with the acquisitions and incorporates nine different technology stacks largely deployed on Amazon’s AWS platform. By having these modules integrated into a seamless platform, our customers will be able to manage the entire clinical operations process through a single solution. That is our novel vision and what differentiates us in the marketplace.”