Getting to market quickly and efficiently
With over 15 years’ experience in conducting early phase clinical trials for Biotechnology and Pharmaceutical companies, Nucleus Network understands the evolving landscape of drug development.
Access to patients, shortened recruitment timelines, and the evolution of pharmacodynamic (PD) biomarkers are key fundamentals underpinning Nucleus Networks multi-country, multi-site approach to Phase 1 clinical trials.
Different trial designs require different expertise. From complex first in human clinical trials to large volume scale biosimilar and through to the management of severely impaired renal patients, Nucleus Network recognizes the different strategies required. This includes having specialized physical infrastructure and specialized recruitment strategies to deliver for our clients.
Our Phase 1 facilities are supported by a highly trained and dedicated team of medical personnel (FRACP), including clinical pharmacologists, oncologists, nephrologists and infectious disease physicians. Specialized Phase 1 facilities also ensure our teams are highly experienced in particular trial designs, and can be considered specialists rather than generalists in their approach.
The strategic co-location of our Australian Phase 1 facilities in prominent Hospitals, and our USA Phase 1 facility co-located within a life sciences and biomedical research precinct, are ideal locations for safety and accessing specialist PD biomarkers. These locations are also well serviced by public transport for healthy volunteer and patient recruitment.
Each of our Phase 1 facilities have undergone FDA inspections and our Australian Phase 1 facilities have also undergone EMA inspections and ANVISA certification. USA FDA regulatory inspections include NDA, 505b2, ANDA and biosimilar regulatory filings. EMA inspections include biosimilar regulatory filing.