The CRO team brings strong expertise in designing, conducting, and managing both interventional and observational clinical studies across medicines, medical devices, and dietary supplements.
Contract Research Organization
SCF is a CRO committed to supporting sponsors throughout the entire clinical research journey, always ensuring full compliance with Good Clinical Practices (GCP), ISO 14155, and Ministerial Decree DM 15.11.2011, underpinned by a strong quality system.
From Phase I trials to Real World Evidence (RWE) studies, SCF stands as a trusted partner for all stakeholders involved in the design and execution of clinical studies.
Clinical Operations
At SCF, medical writing is a collaborative effort, working closely with investigators and sponsors to meet the needs of Ethics Committees and regulatory authorities. We support the development of synopses, protocols, Investigator’s Brochures (IB), and all study-specific documents, while handling regulatory submissions and managing the Clinical Trials Information System (CTIS) efficiently and reliably.
Monitoring
Our monitoring activities ensure that every piece of data is accurate, complete, and fully compliant with the protocol and regulations. From the Site Initiation Visit (SIV) to the Close-Out Visit (COV), we oversee the study at every stage, ensuring the proper start of the study, monitoring progress, and a quality-driven conclusion. This proactive approach prevents issues, promote best practices, and delivers results that are both reliable and transparent.
Statistics
Statistical activities start from the study design phase, including sample size determination and the development of the Statistical Analysis Plan (SAP), continue throughout the study, and culminate in data analysis and the preparation of the final statistical report. This comprehensive approach ensures robust, reliable, and high-quality results.
Clinical Data Management
Data collection and management is a crucial aspect of clinical trial documentation, which SCF ensures through Clinical Data Management activities. These include the design of pCRF/eCRF (FDA 21 CFR Part 11 compliance), the preparation of the Data Validation Plan, query management, and SAE reconciliation.
SCF provides data collection services for clinical trials (Electronic Data Capture/EDC) with a strong focus on reducing study design timelines—from database development and validation to user training optimization and the implementation of EDC platform phases
Quality and Audit
SCF always operates under robust Standard Operating Procedures (SOPs) to ensure that all activities are fully compliant with GCP and regulatory requirements. SCF performs GCP audits following EU Annex 11, ICH E6, and ISO 14155 standards, as well as clinical research audits supporting Phase I–III studies, guaranteeing quality and compliance at every stage.