MAPS expands from startup roots into Phase 3 clinical research

The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit research and education organization focused on advancing the understanding and therapeutic use of psychedelics and related compounds.

What began as a small startup has rapidly evolved into a growing clinical research organization, now advancing into Phase 3 trials. With headcount expanding from around 20 employees to over 100 in under a year, the organization’s operational needs changed just as quickly as its scientific ambitions.

When growth exposed the limits of paper-based quality systems

As MAPS scaled, its quality management processes struggled to keep up.

Standard operating procedures were not consistently tracked, training oversight relied heavily on manual systems, and critical documentation was managed through spreadsheets and paper-based processes. This created both operational inefficiencies and potential compliance risks.

With more studies, more personnel, and increasingly complex regulatory expectations, the gaps in the system became harder to ignore.

The team also conducted a cost analysis comparing continued use of paper-based systems versus transitioning to a cloud-based solution. The results were clear: inefficiencies in time, resources, and oversight meant the return on investment for a digital system would be realized within the first year.

Searching for structure, visibility, and control

MAPS needed more than a document repository. They needed a system that could support controlled documentation, ensure training compliance, and scale alongside a rapidly growing clinical program.

The organization selected Montrium’s Quality Connect platform to centralize SOPs, training records, and quality workflows in a single, compliant environment.

Moving from spreadsheets to a connected quality system

With Quality Connect in place, MAPS transitioned away from fragmented tracking methods and manual logs toward a structured digital quality management system.

SOPs and controlled documents could now be created, updated, and linked directly to training workflows. This allowed teams to identify gaps in training more easily and ensure employees were aligned with the latest procedures before starting their roles.

Training management also became significantly more efficient. Onboarding workflows that once required substantial manual effort were replaced with automated assignment and tracking through Training Connect.

Even distributed and remote teams could now collaborate more effectively through centralized, cloud-based access to documentation and training materials.

Strengthening compliance while improving day-to-day efficiency

Beyond onboarding and training improvements, MAPS also saw significant gains in compliance control and audit readiness.

Controlled documents could be tracked more reliably, reducing the risk of outdated or missing SOPs. Training requirements for both internal staff and external contractors became easier to assign, monitor, and verify.

Electronic workflows replaced manual coordination, allowing teams to process documentation faster and maintain clearer oversight of investigational medicinal product (IMP) requirements, including shipping and labeling documentation. As a result, compliance shifted from a reactive effort to a continuously monitored system embedded into daily operations.

Impact summary

By implementing Quality Connect, MAPS modernized its quality management infrastructure and reduced reliance on manual, paper-based systems. The organization improved training efficiency, strengthened audit readiness, and significantly reduced operational costs while supporting rapid organizational growth and Phase 3 clinical development.