Clinical Trial Management Efficacy
Multi-Site Infectious Disease Network for Early Phase Clinical Trials To ensure proper recruitment and organization, SGS has developed a hybrid hospital network model which encompasses our historical and main clinical pharmacology unit in Belgium, supported by a satellite phase I unit in a major regional hospital, and several partnering hospitals with infectious disease departments. SGS’s clinical pharmacology unit is located in Antwerp, Edegem with a total of 110 hospitalization beds.
For a faster, targeted clinical trial execution and patient recruitment, clients can rely on SGS’s: • Extensive database of investigators and key opinion leaders with therapeutic experience in infectious diseases. • Specific skill-sets to successfully execute studies in respiratory and infectious diseases. • Favorable regulatory environment in Belgium with very short phase I trial approval timelines (14 working days).
For optimized early phase clinical trials, the unit features: • A biosafety Level 2 quarantine facility
ensures an efficient, harmonized training and study execution level for complex evaluations required in infectious diseases trials. Overall, the multi-site hospital partnership network enables: • A flexible and tailored approach to meet sponsor timelines • Faster study start-up and sites activation through established Clinical Trial Agreements • A high rate and qualitative recruitment level: access to large and diverse patient populations for infectious disease indications. Having a dedicated patient recruitment expert within the CRO team allows reliable and predictable patient recruitment, and the wider the network, the greater the hospitals’ databases are, including newly diagnosed patients or referrals from the established physician network.
• A GMP production facility for on-site formulation • Full eSource clinic automation (EDC) including sample tracking for safety lab data • The Clinical Pharmacology Unit (CPU) has successfully passed several US FDA inspections during recent years. Benefits of The Sites Network Concept The clinical sites bring the infrastructure and a group of referring infectious disease specialists and general practitioners (GP) who are highly motivated to carry out early phase studies. It guarantees a secured access to the targeted patient population. SGS staff within the network
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