Introduction

The Drug and Device Phase I Clinical Research Ward/Demonstration Research Ward of Shanghai Sixth People's Hospital covers an area of 1,400m2 and employs 19 research medical professionals, including 6 research doctors, 11 research nurses, and 2 study coordinators. The ward is divided into two sections. The Phase I ward comprises 24 beds equipped with bedside/portable electrocardiogram monitoring equipment (30 units), resuscitation carts, defibrillators, ventilators, electrocardiographs, infusion pumps, and injection pumps, among other devices. It provides a private and cozy environment for healthy volunteers, spacious and bright observation rooms, clean and tidy dining areas, and comfortable recreational spaces. To ensure the authenticity, completeness, and traceability of all data collection and management, the Lakestore system is utilized, making all examination original records traceable.
Through collaboration, the Demonstration Research Ward effectively navigates the complexities of conducting first-in-human trials for innovative drugs, safety and tolerability studies, Phase I pharmacokinetics/pharmacodynamics, biologics, bioactive drugs, new dosage forms, food-drug interaction studies, drug-drug interaction studies, and bridging trials. Additionally, the Ward houses 30 beds for Phase II-III clinical research patients, which are available for researchers to initiate clinical studies as soon as they pass ethics verification. The unit is equipped with a pharmaceutical dispensary, sample processing and storage rooms, and a temperature management system for drugs and samples monitoring, including transportation, reception, storage, and testing.

Moreover, the Demonstration Research Ward provides research platforms such as single-cell sequencing, multi-color fluorescence microscopy, and third-generation sequencing. Adhering to the principle of "Everything for the Patient" in Good Clinical Practice (GCP), the ward cooperates sincerely with sponsors and Contract Research Organizations (CROs), following scientific and ethical principles, rigorously, objectively, and normatively conducting every project. The team continuously strengthens team building, ensures the quality of clinical trials, and constructs a high-standard drug clinical trial research center.

Specialties

All clinical trials operate under strict adherence to international and local Good Clinical Practice standards, ensuring meticulous management and monitoring of clinical studies with standardized management systems, quality assurance mechanisms, and a volunteer screening database system. Each functional area is equipped with independent access controls and corresponding authority settings, while bathrooms are fitted with emergency call systems and observation rooms. With 24-hour closed monitoring management and high-speed wireless AP coverage, research physicians are enabled to conduct comprehensive medical monitoring of subjects.

The single rooms are intended for patients requiring "intensive care unit" treatment, equipped with the latest equipment for bedside electrocardiographic monitoring, and laminar airflow control is implemented for immunodeficiency patients. A mobile rescue vehicle, stocked with emergency medications and respiratory balloons, stands ready for in-situ rescue operations and swift transfers to the NICU via the green channel, ensuring the safety of subjects.