Our Expertise
Knowledge • Reputation • Experience
Excellence Through Experience
Our reputation is based on experience and expertise in first-in-human, oncology and complex early phase studies. With almost two decades of international experience and a unique multi-site specialization model, we are a global leader in participant recruitment, adaptive trial design and exceptional delivery in Phase 1 and early stage first-in-human (healthy and patient) studies.
Site Start-Up & Trial Development
Our Site Start-Up team will be your liaison to ensure that your study is supported every step of the way. Starting with ethics submissions, they work together with your dedicated project managers to ensure that our teams have the necessary resources, supplies, product knowledge and training to ensure that your study follows protocol and delivers reliable results.
Project Management
With a strong focus on customer service and satisfaction, our Project Management team lead with a solution-focused approach and leave no questions unanswered. Strong internal collaboration with our expert functional units consider all elements of your protocol and ensure the quality of the delivery matches the expectations of our clients and delivery partners.
Key components of our project management service include rapid project start-up, contribution and collaboration to your overall project design and program strategy, ongoing trend analysis across all project activities, and clear attention to participant safety and data integrity at all times.
Participant Recruitment
With over 100,000 active volunteers in our database, we have the largest and most diverse participant population spanning all backgrounds, ages, demographics and with a wide range of health profiles across our three locations.
We are participant recruitment specialists, with centralized Recruitment and Marketing teams skilled at attracting, screening and matching healthy and patient volunteers to study protocols. We use sophisticated multi-channel marketing strategies to target to secure new participant leads via targeted digital and print advertising campaigns, ensuring we meet recruitment targets in scale, and in specific demographic requirements.
Medical Team
Led by our Chief Medical Officer, Dr Jason Lickliter, our dedicated medical officers and nurses are in daily contact with our participants to deliver trial outcomes. Inspired by the opportunity to improve lives, our medical team takes pride in providing a safe and supportive environment for participants, while ensuring the study proceeds according to protocols, and provides reliable data that our clients can use.
Pharmacy
Our onsite pharmacies are equipped to provide a comprehensive suite of pharmacy-specific services required for various Phase 1 trial types. Supported by A-class facilities and equipment, our team of skilled pharmacists and technicians ensure that the importation, storage and dispensing of your trial products are safely prepared and handled.
Services Include:
- In-house secure/restricted access Pharmacies.
- Dedicated Australian Health Practitioners Regulation Agency (AHPRA) registered team.
- On-site compounding, Aseptic preparation and Powder handling, including:
- Dedicated Class 2 A2 Biosafety cabinet.
- Grade C cleanroom and Grade A laminar flow.
- Schedule 8 poisons permit (controlled substances).
- Overseeing/maintaining study blind.
- Centralized temperature monitoring system (TempTrack) for all storage clinics.
Laboratory Services
Our scientists work in dedicated clinical trials laboratories containing centralized temperature monitored equipment and systems to ensure that samples are safely monitored and stored.
Capabilities include:
- Processing and storage of pharmacokinetic samples.
- Pharmacodynamic processing capabilities.
- Shipping frozen samples to USA, Europe and China for bioanalysis.
Quality Assurance
Our experienced in-house Quality team assures all of our studies meet global regulatory standards. All data produced through our clinics is FDA and EMA ready. As well as adhering to ICH preclinical toxicology and safety pharmacology guidelines, Nucleus Network has been audited by the FDA and inspected by the EMA. Our independent vendor audit performance history spans over 100 sponsor audits.