Clinical Trials

Following is a list of our facility specifications

Clinical Equipment

Device	Brand	Description
1.ECG	Edan SE 1200 Express	12-channel electrocardiograph
2.Infusion pumps	BD Alaris	Volumetric pumps with Guardrails safety software
3.Defibrillator	Stryker	Lifepak Cr2
4.Thermometer	Covidien/Cardinal Health	Genius 3 Tympanic Ear Thermometer
5. Patient scale	Wedderburn WM302	Medical Weight Scale + integrated height rod
6. Sphygmomanometer	Welch Allen	767-Series with cuff and mobile stand
7. Suction Pump	CA-MI	ASKIR 230/12V Surgical Suction Unit
8. Vital Signs monitor	Edan iM3	Digital vital signs machine

Laboratory

Device	Brand	Description
1.Freezer (-20°C)	Matos PLUS	Eco 125 F Medical Freezer*
2. Freezer (-70°C)	Haier DW-86L100J	Ultra-low temperature Freezer*
3.Centrifuge (x2)	Kubota S300TR	Benchtop Refrigerated Centrifuge
4. CRT Cabinet (20°C)	NuLine	NLMi1000 Refrigerated Incubator Cabinet
5. Portable Air Con (x2)	Carrier	Portable Aircon/Heater

* HCTL has an account with Marken NZ to provide dry ice to site within 1 hour in the event of compressor failure

Medical Room

Device	Brand	Description
1.Refrigerator	Matos PLUS	Cloud 300 R/GDT
2. IMP storage	Built in cabinet	Ambient temperature; coded entry
3. Portable Air Con	Carrier	Portable Aircon/Heater

Other

Device	Brand	Description
1.Temperature monitoring	Matos	Ambient & critical equipment temperature monitoring system
2. Air conditioning     a. Normal work hours	Built in	Facility central air conditioning system with room-by-room ambient temperature sensing with individual zone set points
3. Air conditioning     a. After hours/weekend	Carrier (x2)	Floor standing units in Medication Room & Laboratory maintain temperature at 20-23°C when central aircon is off (6pm – 7am weekdays; 6pm Friday – 7am Monday)
4. Back-up generator	Honda	Generator back-up power supply to Medication Room and Laboratory (Essential Supply circuit); Email notification of mains power off/generator on. Approximately 14h run time before fuel tank needs to be refilled.

Electronic Medical Records system – MOSAIQ 

Guest access can be provided – limited to specific trial participant files.

User Agreement required for access. Unique credentials per user.  

Clinical Trial Management System – CRIO 

CRA/Monitor access can be provided – limited to “Monitor View”. 

User Agreement required for access. Unique credentials per user. 

• eSource 
• eRegulatory
• eISF  

Electronic Site Files – FLORENCE 

Guest access can be provided – limited to specific trial binders.

User Agreement required for access. Unique credentials per user. 

• eRegulatory
• eISF Document Management 

MATOS Real-time Temperature Monitoring System 

Our MATOS RTTMS enables live temperature viewing via an online portal, automatic reporting, and email & SMS alerting in case of a temperature breach and/or hardware fault (e.g. loss of network connectivity).

• Fully automatic 24/7 real time temperature and humidity level online monitoring
• Cloud storage integrity guaranteed for at least ten years 
• Full audit history on temperature data and alert history (minimum storage of 15 years) 
• FCC, NZ & Australian Compliance 

Mains power loss

UPS on the IT network maintains data transmission to the cloud.  

IT network downtime

Backup battery in the data loggers allows onboard data collection which synchronises to the cloud once IT systems are restored ensuring no loss of monitoring data.