Quality and compliance
Quality is a pillar in the way FOMAT runs clinical research. Dedicated teams, clear processes and digital tools support every study so data and documentation stay reliable from start to finish.
Oversight across every visit, from first to last
Before enrollment
- Review of informed consent and other documents used at first visits
- In-house eSource configuration and set up before participants are enrolled
During the study
- Review of consent and eligibility to confirm participants fully meet protocol requirements
- Oversight that study teams follow protocol procedures and visit requirements
Throughout the trial
- Corrective and preventive actions followed to closure
Quality built into everyday operations
These values guide how we work with each other, with clinics and with sponsors. They also describe what we look for in new colleagues.
Dedicated quality teams
In-house Quality and Compliance specialists support all studies and locations.
Layered oversight
Ongoing checks and planned reviews keep potential issues visible early.
Digital visibility
Most study documents are completed and reviewed within a shared electronic platform, improving real time oversight and strengthening data collection quality.
Continuous quality mindset
Standard procedures, templates, and training help teams document consistently, keeping study files ready for monitoring visits and audits.
Teams behind quality and compliance
Quality and Compliance work side by side with clinical, regulatory and start up teams.
Quality control
- Reviews source and system data for accuracy and completeness during participant visits
- Verifies safety data and endpoint documentation are complete and protocol aligned
- Supports smooth monitoring and oversight on all studies
Quality assurance and compliance
- Ensures compliance with study protocols, standard operating procedures, and Good Clinical Practice.
- Maintains audit and inspection readiness throughout the study lifecycle.
- Drives continuous improvement by leveraging trend analysis and risk assessments.