Skip to content
1 (2)

ARMR Sciences Strengthens its Quality Management Foundation Ahead of Clinical Trials with ZenQMS

Customer Story | ARMR Sciences
ARMR

About ARMR Sciences

ARMR Sciences is a biotechnology company developing biodefense countermeasures to prevent overdose and addiction. At the center of their platform is ARMR-100, a first-of-its-kind immunotherapy being designed to generate long-lasting protection against fentanyl by neutralizing the drug in the bloodstream before it reaches the brain.

The program represents more than six years of collaborative research with the Department of Defense, scientists at the University of Houston, and other leading U.S. institutions. With plans to begin a Phase I/II clinical study in late 2025 or early 2026, ARMR Sciences is building the operational and compliance infrastructure needed to support clinical readiness and long-term success.

Success Highlights

Audit Readiness_Security
Built a compliant QMS to support upcoming Phase I/II clinical trials.
Workflow_Change Control
Selected ZenQMS for its ease of implementation and scalability.
Audit Readiness_Security
Strengthened quality assurance oversight with validated, audit-ready processes.

Building a Quality Management System in Preparation for Clinical Trials

As ARMR Sciences prepared to move from preclinical research into clinical trials, establishing a fully compliant Quality Management System (QMS) became a key priority. The team had been using a combination of SharePoint for document storage and Adobe for signatures. This approach worked temporarily, but lacked the compliance and control needed for clinical operations.

“We used SharePoint, which didn’t have the full compliance needed for document storage,” said Thomas Warren, Sr. Director, Quality Assurance at ARMR Sciences. “With ZenQMS, we feel that we have taken the necessary steps to ensure the utmost consistency, compliance, and confidence in every stage of development and execution.” 

The team needed a solution that could centralize document management, streamline training, and support compliant approvals within a secure, auditable environment. 

It was time for a dedicated eQMS.

They turned to ZenQMS, a system designed to help life sciences organizations build inspection-ready quality programs without the complexity or overhead of legacy systems.

 

Choosing ZenQMS: Compliance and Simplicity at the Right Scale

As an early-stage biotech organization, ARMR Sciences prioritized a few critical features while evaluating eQMS options:

  • Compliance
  • Ease of use
  • Cost-effectiveness
  • Fast implementation
  • The ability to scale with their growth

“With the size and early stage of our company, price was a major factor. ZenQMS offered what we needed at a reasonable price point.”

The team also valued how easy it was to align workflows within ZenQMS to match ARMR’s early-stage operations, making it easy for them to build compliance into daily work.

Plus, built specifically for GxP-regulated environments, ZenQMS offers a validated, cloud-native architecture with built-in controls to meet 21 CFR Part 11 and Annex 11 requirements. This is ideal for emerging biotechs preparing for clinical operations.

“Overall, ZenQMS had everything we needed: a compliant way to store and approve documents and capture training. The relative ease of implementation felt very appropriate for our stage as a company.”

By choosing ZenQMS, ARMR Sciences gained access to a compliance framework trusted across the life sciences industry, along with a transparent, scalable QMS pricing model that supports growth without added complexity or surprises.

 

Preparing for Clinical Success with ZenQMS

As ARMR Sciences builds toward its first clinical trial, ZenQMS serves as the backbone of its documentation and training framework. The platform enables the team to support required procedures, manage controlled approvals, and maintain compliance throughout the transition to clinical development.

“The compliance piece is key here; that’s why we wanted an eQMS. Our previous system had risks, and ZenQMS mitigates those. The expected positive impact for that risk mitigation is high.”

ZenQMS’s commitment to trust and compliance reinforces this confidence. With a single validated instance, built-in qualification documentation, and over 99.99% uptime, the platform provides the reliability and transparency essential for regulated organizations entering clinical phases.

Initially, ARMR Sciences is focused on the Documents and Training modules, which provide a strong foundation for its quality assurance program. As the company scales, the team plans to expand its use of ZenQMS to include Issues, Change Controls, and Audits for commercial readiness, taking full advantage of the system to evolve in step with the company’s growth.

 

Looking Ahead

For ARMR Sciences, implementing ZenQMS represents an important milestone in building a compliant, scalable quality assurance foundation. The team values the system’s ease of use and the assurance it brings in meeting regulatory expectations as they progress toward clinical and, eventually, commercial stages.

“We really like the ease of the system. For QA, it’s a simple and compliant way to complete what we need.”

With ZenQMS in place, ARMR Sciences is well-positioned to maintain compliance, manage quality with confidence, and stay focused on its mission to protect lives from the opioid crisis.

 

An eQMS Suitable for Clinical Trials Compliance

ZenQMS provides life sciences organizations with a modern, cloud-based quality management system that’s purpose-built to support GxP and clinical compliance from day one. Designed for scalability, it gives emerging companies like ARMR Sciences the tools to manage documents, training, and quality processes with confidence as they move toward clinical milestones.

See how quickly your team can get started with a system that’s easy to implement, fully validated, and trusted across the life sciences industry.

Don't take it from us