Our Compliance and Capacity
Ensuring Quality, Compliance, and Efficiency in Clinical Trials
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We pride ourselves on our unwavering commitment to quality, compliance, and capacity in every clinical trial we conduct. Our integrated approach ensures that we meet and exceed industry standards, delivering reliable and timely data to our clients.
Our Model Ensures Safety & Quality
Our unique model integrates multiple layers of oversight to enhance patient safety, ensuring rigorous compliance and the timely delivery of high-quality data.
Centralized Quality & Regulatory Support
All our sites have centralized support from industry-leading Quality Control, Quality Assurance, Regulatory, and Data Management teams throughout our network.
48-Hour Data & Query Targets
48-hour data entry goal; resolve queries within 48 hours of generation
![Businessman using laptop computer with quality assurance and doc Businessman using laptop computer with quality assurance and document icon for ISO or International Standard Organisation which related quality control and continuous improvement concept.](https://www.fomatmedical.com/wp-content/w3-webp/uploads/2024/07/businessman-using-laptop-computer-with-quality-assurance-document-icon-iso-international-standard-organisation-which-related-quality-control-continuous-improvement-concept.jpgw3.webp)
Streamlined Study Start-Up, Regulatory Compliance, and Data Integrity
Our integrated approach ensures seamless clinical trials through efficient study start-up, regulatory support, and clinical data management. The teams work together to maintain data integrity and regulatory compliance.
Study Start-Up Squad: Accelerates study start-up
Regulatory Support:
- Maintains clinical trial documentation
- Facilitates FDA audits.
- Conducts EDC and source cross-checks.
- Supports data handling and quality requirements.
- Collaborates on project management and training.
Quality Control and Assurance: Ensuring Compliance and Integrity
Our quality control process involves a thorough review of participant source data to identify errors, variances, deviations, or protocol clarifications. A QC review meeting is held before the study begins to ensure protocol readiness and compliance for the first visit. Our team:
- Conducts study start-up training meetings to prevent protocol deviations and equip sites for success.
- Reviews 100% of source data for the first five participants.
- Reviews informed consents, eligibility visits, and ACLOA-C standards.
- Targets reviews for missing concomitant medications, AEs/SAEs, and primary endpoints.
Our quality assurance prioritizes participant safety and data integrity, ensuring protocol compliance throughout the study.
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Develop
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Engage
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Deliver
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Plan
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Educate
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