Nucleus Network is Australia’s leading clinical research organisation for the conduct of Early Phase Clinical Trials - its people, facilities and problem-solving culture provide excellent service to global pharmaceutical and biotechnology companies.

The clinical trials performed at Nucleus Network involve either healthy volunteers and/ or patients with specific medical conditions.

Its main features include:

• State-of-the-art in-patient facilities (46 beds) with access to diverse patient and volunteer populations and specialized investigator networks.
• Clinical trial consulting services available to create a full clinical development plan and regulatory filings for clinical trial approval and marketing authorization for Australian and international agencies such as TGA, FDA and EMEA.
• Extensive experience working with international companies- 75% of Nucleus Network’s customer base is located in the USA and Europe; Nucleus Network currently conducts clinical trials for 7 of the top 10 global pharmaceutical companies
• GCP trained, experienced and dedicated clinical research professional staff.

Study facility capabilities

• Telemetry units to all dosing beds
• Call bell services to all beds
• Oxygen and suction available to all beds
• Recreational and computer rooms
• Dedicated study monitor area
• Technical Laboratory with centrifuges and temperature monitored -70ºC, -20ºC and 2-8ºC storage facilities for samples

Volunteers and Specialised Patient Groups

• Caucasian, Japanese and Chinese Cohorts
• Pharmacy Services
• Full time Clinical Trial Pharmacists
• Capabilities include aseptic reconstitution, cytotoxic admixing, blinded packaging, comparator supply, labelling, import permits and temperature monitored storage
• Radio-pharmacy

Full Range of Clinical Testing Services:

• Cardiology (Echo, ECH, Holter monitoring)
• Vascular (Duplex Scans, ABI)
• Respiratory function testing (Full range)
• Neuroscience testing (Ultrasound, EEG, EMG, NCS, evoked potentials)
• Sleep laboratory testing

X-Ray, CT, MRI, Pet Scanning

• Preclinical GAP Analysis
• IND, IMP, CTX and CTN Preparation
• Investigational Brochure and Protocol Preparation
• Pre-IND Meeting Packages and Requests
• Australian, EC and US Marketing Applications
• Trial planning and management
• Cost estimates and timelines
• Preparation, submission of, liaison with EC
• Data entry/management