Clinical trial regulatory support, monitoring and Good Clinical Practice compliance.
FMS Baltic provides specialised clinical development and GCP consulting services to pharmaceutical companies, biotechnology organisations, clinical research organisations (CROs) and clinical trial sponsors.
We support clinical research activities through regulatory coordination, trial oversight, monitoring and assessment of compliance with applicable Good Clinical Practice requirements.
We also support medical device clinical investigation planning, regulatory documentation and compliance with applicable EU Medical Device Regulation (MDR) requirements.
What We Offer
- Clinical trial regulatory strategy and submission planning
- Preparation, review and coordination of clinical trial applications
- Clinical Trials Information System (CTIS) submissions and amendments
- Support for regulatory authority and ethics committee interactions
- Clinical trial documentation review and compliance assessments
Clinical Trial Monitoring
- Clinical research associate (CRA) services
- Site feasibility assessments and site selection support
- Site initiation, monitoring and close-out activities
- Review of trial documentation and protocol compliance
- Identification, documentation and follow-up of monitoring findings
GCP Compliance and Quality Assurance
- GCP gap assessments and compliance reviews
- Preparation for sponsor audits and regulatory inspections
- Remote and on-site GCP audit support
- Review of clinical trial standard operating procedures (SOPs)
- Corrective and preventive action (CAPA) planning and follow-up
Clinical Trial Regulatory Documentation
- Trial Master File (TMF) and Investigator Site File (ISF) review
- Assessment of essential documents and trial documentation completeness
Flexible Clinical Development Support
FMS Baltic offers project-based clinical trial regulatory and GCP compliance support, including defined monitoring, documentation review and audit-related assignments. The scope of each engagement is agreed according to the study, jurisdiction and applicable regulatory requirements.
Discuss Your Clinical Development Requirements
Contact FMS Baltic to discuss clinical trial regulatory submissions, site monitoring, GCP compliance or medical device clinical investigation support.