Veeva : 2021 R&D Heroes Tackle the Technical, and Human, Sides of Change

Change management is one of the greatest challenges facing the industry as it moves toward streamlined, modern operations. Behind grand buzzwords such as digital transformation are thousands of small, hard-won victories.

People may question the need for change, fear its impact on their jobs, and struggle to get over the comfort of old, familiar tools. Moving them requires communication, sharing why change is needed, and how it is improving operations. "You can give somebody the best tool in the world, but if they persist in trying to work around it, you will never realize the efficiencies that it was designed to give," says Emma Earl, head of systems support, Global Clinical Trial Services, at Bayer, which is modernizing its approach to clinical operations and data management.

For taking on both the technical and the human sides of modernization, Veeva recognized the special leadership of its 2021 Heroes, including Emma, at the Veeva R&D and Quality Summit, North America. During a time of intense change and uncertainty, they visualized workflows that had never existed before and ways to break down barriers between operations, corporate divisions, and people. Their work continues to help colleagues face fears of the unknown and see a bigger picture that, in the end, promises to benefit patients. Here are their stories.

Emma Earl, Head of Systems Support, Global Clinical Trial Services, Bayer

Emissary of Integration

Emma enabled her Clinical Development Operations function to improve collaboration with research sites, eliminate system silos, and streamline end-to-end processes as she led implementation of Veeva Vault eTMF, Veeva Vault Study Startup, and Veeva Site Connect at Bayer. So far, these efforts have standardized global procedures, provided data for enabling continuous improvement, and changed users' perception of clinical operations management by moving from a "repository"-based eTMF to an integrated approach. Emma's teams' interactions with clinical research sites, which are often burdened by customized point solutions from sponsors, has simplified interactions with sites and helped position Bayer towards its goal as a sponsor of choice.

Emma sees cloud-based technology as a great enabler of efficiency but has no illusions about the challenge it can pose to some first-time users. Paper may have been tedious, but its work processes were simple, well defined, and extremely flexible. For novice users of new systems, "decision paralysis" can set in when they must set boundaries around work processes, she says.

For more about Emma and her team's efforts, watch her fireside chat interview at the Veeva Summit.

Eric Guitard, Vice President of Systems Integration, Lotus Clinical Research

The CRO whisperer

Eric was instrumental in helping Lotus, a clinical research site with expertise in pain management, establish a full-service CRO business. By unifying Lotus' clinical data landscape, he set up a framework for clinical data and operations that has reduced the time and cost of clinical trials, using Veeva Vault CDMS, Veeva Vault eTMF, and Veeva Vault CTMS. A new design environment within Vault CDMS reduced the need for custom programming, allowing data managers to develop most of the studies independently and decreasing study startup times by 67%.

Lotus had gradually moved into the CRO business as more clients asked it to take over operation of their clinical trials. In 2013, the company recruited Eric, who brought a deep insider knowledge of CROs and how they work, as well as experience building, using, and managing clinical data systems. Two years later, Lotus' CRO was an independent subsidiary.

Today, Lotus is thriving as a combined research site and full service CRO. After managing 10 to 12 studies per year independently, Eric recently hired a full-time IT manager and programmer, and the company completed a Phase III study that went to registration with zero findings during an FDA audit. "Veeva has really changed the way we run clinical trials," he says.

For more insights, watch Lotus' former clinical data manager, Andrea Krueger, discuss the implementation.

Diane Larson, Director of IT Account Management, Merck

Unification champion

Corporate mergers may bring new capabilities, but they can also result in redundant legacy systems and complexity. After acquiring Schering-Plough in 2009, Merck gained agility by restructuring its research and its manufacturing divisions. However, its quality management systems had become more complicated, while its different divisions had become siloed.

Diane Larson, director of IT account management, led a team that implemented Veeva Vault QualityDocs and Veeva Vault QMS across both research and manufacturing divisions. The project replaced aging systems that no longer supported Merck's large, complex, and globally dispersed operations. Diane's efforts streamlined workflows and brought greater efficiency and improved cross-functional communication and understanding.

"There's always user fatigue with projects like this, but the key is sharing overall strategy and keeping everyone aware of progress," Diane says. Communication and regular check-ins have been key to the project's success. So far, her efforts have consolidated workflows for seven functional areas and developed a single governance structure for both Vault QMS and Vault QualityDocs, across R&D and manufacturing.

In the future, Diane plans to extend the QMS into risk management and, ultimately, hopes to harness the power of predictive analytics to prevent quality problems at the source. For more information, watch Diane's interview at Veeva's 2021 North American R&D and Quality Summit.

Jason Maze, Director of Global Regulatory Systems and Information Management, Dermavant Sciences

Publishing wizard

Publishing is a challenging endeavor, but the stakes are especially high for innovators submitting their first new drug application (NDA) to the FDA. Jason Maze, director of global regulatory systems and information management at Dermavant Sciences, saw that most life sciences companies treated publishing as a peripheral task, rather than integrating it into day-to-day processes.

He turned this mindset upside down by introducing colleagues to Veeva Vault RIM. "I wanted to move toward real-time publishing," Maze says, "and to push quality check and copyediting upstream to authors." Overall, the team's efforts shortened the time required for publishing by six weeks, shaving more than a month off the NDA timeline. As a result, Dermavant was first to market with its new therapy, while streamlined processes, content, and data will allow its publishing team to work smarter and faster in the future.

Learn more about the project in this case study.