Clinical Pharmacology Unit
Clinical Experience SGS CPU performs on average 30 combined protocol Phase I trials per year and randomizes around 3.000 subjects in this period. We have over 13.000 active volunteers registered in our central database. We are an early clinical development specialist in: • FIM studies (including complex umbrella and adaptive designs) • Regulatory Phase I trials (including: TQT/QTc, BA/BE, DDI, HI/RI trials) • Particular Phase I trials requiring technical complexities on several fields such as laboratory, nursing, medical and pharmacy complexities • Exploratory Phase I trials (including: micro-dosing and POC trials) • Viral (and other) challenge trials
SGS Clinical Pharmacology Unit (CPU) is one of the leading Phase I Units in Europe, conducting complex Phase I-IIa clinical trials, in healthy subjects and as well as in different patient populations. SGS CPU is located on the grounds of the University Hospital Antwerp in Edegem, Belgium and occupies a total area of 6.500 m², in a dedicated, purpose-built building connected to the hospital.
Main CPU Facilities The SGS CPU has 3 dedicated wards with a total bed capacity of 110 beds: (1) a general ward with 64 beds, including a 8 bed special ‘High Care’ unit, (2) a specialized 30 bed isolation unit, (3) a 16 bed isolation unit. Each ward is equipped with dedicated areas to support study execution and assessments: a nurse station, a sample management laboratory and long term storage room and a dedicated material preparation room. Clinical samples
(blood, urine, feces, CSF, PBMC) are handled by a team of dedicated lab technicians, trained to manage complex samples according to the protocol/lab manual. Study participants will enjoy their long-term stay in luxury individual or 2 to 4-person bedrooms, with dedicated lounge/resto area. By conducting healthy volunteer studies at SGS CPU, sponsors benefit from favorable regulatory timelines; only 15-day approval for the Ethics Committee (EC) and the FAMHP, the Belgian Health Authority (HA), allows for quicker study and site start-up compared to other Phase I Units in European countries.
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