ProTrials Achieves a Scalable Quality System and 98% Training Compliance with ZenQMS

Running a contract research organization means every process must stand up to scrutiny, from client audits to regulatory inspections. For Kristen Regan, Quality Assurance Specialist at ProTrials, ensuring compliance across teams and projects is an everyday priority.

“We’re a small but mighty CRO – about 100 to 125 people,” Regan said. “Our QA team is just two of us now, but we’re the super users of ZenQMS. I spend a great deal of time in the system, tracking training, CAPAs, and audits to ensure the workflows are moving efficiently.”

Before adopting ZenQMS in 2022, ProTrials relied on manual systems to manage quality. 

Previous training documentation was captured via an electronic signature platform, tracked in a Microsoft Database, and housed in Quality Assurance files. That approach worked when the company was smaller, but as the business expanded, the limits of a paper-based system and the need for more efficiency became clear.

“We were paper-based before Zen. Our group had to manually make sure the right people were receiving the right training. Human error could easily be introduced there.”

In 2021, ProTrials brought in a new QA Director who made modernization a priority. The goal was to find an electronic quality management system (eQMS) that could bring structure, automation, and traceability to every core process.

Choosing Configurability Over Complexity

When evaluating options, ProTrials looked for a platform that could adapt to the way its teams already worked. The essentials for a small QA group supporting a growing business included:

• Flexibility
• Usability
• Cost efficiency

“Cost was certainly a consideration. But also, the fact that we could implement it the way we wanted to – that was really big.”

ZenQMS provided the configurability that ProTrials needed to align the system with existing SOPs and internal terminology. The QA team could design workflows around their specific needs without custom code or lengthy implementation projects, and it was all supported by ZenQMS’s transparent, growth-friendly pricing that makes quality management accessible to teams of any size.

“We could configure our documents in the way we wanted, capture the training the way we wanted, stage things out our way.”

That alignment allowed the company to transition smoothly from manual oversight to an automated, transparent process. 

What began as a software implementation became the foundation for a scalable, organization-wide quality framework.

Achieving Over 98% Training Compliance

ProTrials implemented ZenQMS in 2022, beginning with its training program. The goal was to eliminate manual tracking and ensure every employee completed the right training at the right time.

ZenQMS automatically assigns courses based on company roles and SOP updates, while real-time dashboards help QA monitor progress across the company. The change was immediate.

“We don’t often fall below 98% when a training deadline approaches – and we pride ourselves on that.”

That high level of compliance reflects both the efficiency of the platform and the engagement of ProTrials’ staff. With automation handling reminders and assignments, QA can focus on analysis and continuous improvement rather than chasing completions.

Key Results

• 98%+ on-time training completion across departments
• Automated role-based training assignments
• KPI dashboards and training visibility for management

“It’s a big time saver,” Regan added. “You upload the updated training, and ZenQMS automatically pushes it out.”

Managing CAPAs and Audits with Structure

Beyond training, ZenQMS has streamlined how ProTrials tracks CAPAs and manages audits. For a CRO balancing multiple clients and timelines, keeping every quality issue on schedule is essential.

“If we have something like a CAPA, it has to be closed in a certain amount of time. Zen lets us configure those timelines so we are on track.”

The visibility those reminders provide helps not only QA, but also project and clinical team members who balance multiple client priorities. With clear timelines and automated notifications, everyone stays aligned on what’s due and when, ensuring issues close on time and projects stay on schedule.

ZenQMS also houses all controlled documents, providing a single, current repository that simplifies audits and client reviews.

“Clients always want to see our controlled documents. They’re all in Zen. Everything’s current and version-controlled, so we can respond quickly when clients or auditors ask for something.”

The result is a structured, reliable approach to audit readiness – every document, CAPA, and training record available in one place, backed by consistent version control and supported by ZenQMS’s validated, audit-ready platform built for data integrity and regulatory compliance.

Support That Feels Like Partnership

For Kristen and her colleagues, ZenQMS’s value extends beyond the platform itself. The customer support and implementation teams have become an ongoing resource for refinement and collaboration.

“I should send a bouquet of flowers to the support team. They’re always responsive, and have been hands-on to find solutions or workarounds when we need them.”

This partnership has helped ProTrials adapt its workflows and respond quickly to regulatory or client changes. The QA team continues to work closely with ZenQMS as new capabilities are introduced.

A Scalable Culture of Quality

Three years after implementation, ZenQMS remains a core part of ProTrials’ compliance infrastructure. The QA team continues to refine how it uses the system, expanding into new reporting and access controls to manage sensitive information.

“ZenQMS is easy to use once you’re in it every day,” said Regan. “The support team is nimble, they listen to feedback, and they make changes that help us work better.”

What started as a system replacement has become a long-term strategy for scalable, transparent quality management. Today, ProTrials operates with a level of structure and visibility that supports both client confidence and internal growth.

For other CROs looking to modernize their quality systems, we offer practical guidance in our eQMS Quick-Start Guide for Contract Research Organizations. The guide outlines best practices for implementing a right-sized, validated quality management system that scales with growth.

Learn More

To see how ZenQMS helps organizations like ProTrials strengthen training compliance, CAPA management, and audit readiness – check out our 3-minute demo.