Nucleus Network   Overview Nucleus Network aims to deliver solutions to the industry for managing the bio-pharmaceutical product lifecycle. The goal is to reduce the time, risk and cost associated with the development and commercialisation of new medicines and devices. A platform was created for clinicians and researchers to market their talents globally, while providing a shared infrastructure that would keep abreast and lead the way for excellence in clinical research performance. Its main features include: Quality driven specialized Phase I and early phase clinical research capabilities 30 bed and 16 bed state-of-the-art specialized in-patient facilities with access to diverse patient and volunteer populations and specialized investigator networks. All clinical trials in Australia are conducted to ICH-GCP guidelines and recognised by global regulatory authorities. Nucleus Network currently conducts clinical trials for 7 of the top 10 pharmaceutical companies staff are experienced and dedicated to clinical research. Continuous cardiac monitoring (telemetry) to all beds. 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. Business Opportunities (i.e Corporate Alliances/Partnerships) Looking for opportunities to conduct early phase clinical trials for Biotech and Pharma companies. For: Phase I Chemical Entities Biologicals Pharmacokinetic Oral Inhaled Drug Interaction Patient Studies First time in Patient Patient Study Technology/Products and Services Description 30 + 16 bed purpose-built inpatient facilities for healthy volunteers and specialised patient groups Study capabilities: Proof of concept First time in man Patient studies Pharmacokinetic/pharmacodynamic Bioequivalence/ bioavailability Pharmacogenomics Japanese vs Caucasian metabolism Preclinical GAP Analysis Regulatory Development Plans 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 Statistical services Feasibility assessments Consulting in pharmacokinetics Competitive Advantages Flexible and efficient regulatory system (Internationally compliant) Clinical trial data acceptable to the FDA Cost effective Southern Hemisphere Streamlining Ethics and review of multi-centre research (DHS/DIIRD) Website address: www.nucleusnetwork.com.au