SGS | Phase I Patient Unit-Mechelen

Phase I Patient Unit AZ Sint-Maarten Hospital, Mechelen, Belgium

Health Inspired, Quality Driven.

SGS's Phase I Patient Unit supports early phase clinical trials in patients. A qualified site for enrollment and study conduct.

The Phase I Patient Unit at AZ Sint-Maarten Hospital is part of the SGS Health Science clinical trial network. This unit supports early phase clinical trials, providing access to patient populations, and working as a qualified site for enrollment and study conduct.

Site information This Patient Unit is situated within AZ Sint-Maarten Hospital in Mechelen, Belgium, and is dedicated to the early phase testing of medication in patients. The safety and quality of the studies is ensured thanks to a staff of highly experienced and multilingual professionals.

Facilities The Phase I Unit for patient studies occupies a wing in proximity to the intensive care unit of the hospital. In addition to the dedicated clinical trial patient rooms, the unit is equipped with a sample preparation/storage area and individual bedrooms adequate for multi- day stays. The AZ Sint-Maarten Pharmacy and Lab, with its experienced staff, are fully adapted to support patient studies under controlled procedures. SGS’s Antwerp CPU is in close proximity and provides lab and pharmacy support when needed.Special IMP- preparation requests are handled by SGS’s Antwerp CPU production facility, which is GMP-licensed.

Operational ownership by SGS medical staff and investigator 24/7 medical control of trial participants Full time availability of hospital emergency staff

Patient recruitment & study execution The unit was created to significantly increase reach and patient trial capabilities in early phase clinical trials within Belgium. This Phase I Patient Unit has constant and reliable access to most of the patient populations treated in the AZ Sint-Maarten Hospital. The AZ Sint-Maarten Unit plays a crucial role in the early phase studies conducted by our SGS Clinical Research personnel and Clinical Project Managers. As part of the SGS Health Science clinical network, the AZ Sint-Maarten Unit can operate as single Unit or in a multi-site approach, depending on the needs of the study.

Clinical trial safety and quality are primary concerns throughout the entire study at AZ Sint-Maarten, and the professional staff at the hospital are there to provide full support, such as crash teams on stand- by 24/7.

Added value in clinical trials

Dedicated therapeutic and clinical development experts, assessing feasibility and ensuring smooth study conduct An experienced SGS-team of Investigators, Patient Site Managers, and Clinical Trial Nurses, with a proven track record in a variety of studies An experienced AZ Sint-Maarten team of clinical trial coordinators and study nurses

Single patient bedrooms, dedicated to phase I clinical trials Close proximity to SGS’s primary Clinical Pharmacology Unit in Antwerp, Belgium allows for easy multi-site coordination and cross-site support Fast study start-up due to short turnaround time for Regulatory Authority and Ethics Committee approval (favorable compared to most countries in Europe) Solid recruitment capacity for patients, ensuring rapid subject enrolment and study delivery within timelines AZ Sint-Maarten physicians co- operating with SGS recruitment team Additional support from SGS’s in-house Patient Site Managers

Experience & Therapeutic areas AZ Sint-Maarten Hospital has been conducting early phase patient clinical trials since 2016. Hospital physicians are collaborating with SGS to conduct these studies. We offer a full package service with complete project oversight and dedicated therapeutic expertise, including:

Cardiology Endocrinology Geriatrics Gastroenterology Hepatology Neurology Orthopedics Pneumology Vascular Surgery

Health Science Health Inspired, Quality Driven.

Contact us SGS Clinical Research

+32 15 27 32 45 healthscience@sgs.com sgs.com/healthscience sgs.com/healthcommunity

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