Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Before implementing Pinnacle 21 Enterprise, the clinical data programming team at MacroGenics faced several operational challenges:

MacroGenics used to outsource the complex task of generating Define.xml files to external vendors, limiting the team’s control over this activity.

Addressing validation issues was also a challenge. Daner had to recount previously used issue explanations from memory, which often resulted in her using different phrasing for similar explanations across studies. This inconsistency made it difficult to have standardized content for issue resolution.

Communication between the clinical programming team, data managers, and third-party vendors also had its challenges. Programmers had to copy and paste issue details into emails to data managers, which was time consuming and made it easy to lose track of progress.

MacroGenics adopted Pinnacle 21 Enterprise in 2019. The platform provided a centralized, collaborative solution that enabled easier communication between teams and standardized validation and issue management processes.

P21E’s user-friendly interface impressed the team. “When we made the decision to adopt Pinnacle 21 Enterprise, I just fell in love instantly. It’s just like using an Excel spreadsheet; I find it really easy to use with little training,” said Daner Li.

Daner was mostly impressed by the Define.xml generator. Instead of relying on vendor support, she could now create the file herself in just two days.

“The first time I was able to generate it myself, I thought: this is the best thing ever,” she recalled. The ability to generate a Define.xml file from validated data also helped uncover issues that manual reviews had missed.

P21E gave MacroGenics’ data managers and third-party vendors access to one centralized platform: a single source of truth. Data managers could proactively identify and resolve data issues themselves, commenting directly within the platform. This made a big difference, especially for complex domains: data managers could understand and resolve many issues independently, saving valuable time for the programming team.

The centralized platform also helped streamline work with MacroGenics’ vendor in India. By providing access to P21E, both teams operated under one set of rules on a single platform, reducing validation discrepancies.

The issue management functionality in P21E allowed Daner to create standardized explanations and fix tips for recurring issues. This metadata could be reused across studies, ensuring that all team members, including newer programmers, had clear guidance.

“All stakeholders are able to access everything very easily in one place, it definitely saves a lot of time and energy,” Daner noted.

With the adoption of Pinnacle 21 Enterprise, MacroGenics saw significant improvement across clinical data operations.

The most significant impact was the time saved. By standardizing issue explanations and reusing them across studies, the team streamlined a once manual process.

“With the issue metadata management functionality in P21E, you standardize everything, and all the future studies can use it,” said Daner. The platform also allowed for rapid scaling to include more data managers and vendors in the process as required.

Another significant benefit was the ability to validate data continuously throughout a study’s lifecycle, rather than at the end. The team could catch and resolve issues as they arose. The data fitness score provided a clear, real-time measure of submission readiness.

“The data fitness score makes my life so much easier. It’s a good feeling when you see the fitness score go up, because I’m always aiming for 100%,” Daner shared. This proactive approach ensures higher data quality and greater confidence at study close-out. “It really helps with the study close out. We catch and resolve all the issues, so we can be confident that this is the best result that we get.”

MacroGenics’ partnership with Certara has streamlined its validation of clinical data management and programming strategy. By moving from manual, siloed processes to a centralized, collaborative, and standardized platform with Pinnacle 21 Enterprise, the team has achieved gains in efficiency and data quality.