The Background
Early clinical-stage US biotech DiaMedica engaged Novotech to provide CRO services and help it take advantage of Australia’s supportive early stage research environment and the country’s rapid regulatory processes.
Early clinical-stage US biotech DiaMedica was keen to take advantage of Australia’s supportive early stage research environment for its next phase I study but knew it would require guidance in accessing the country’s rapid regulatory processes and large network of phase I units.
Challenge
Appreciating Novotech’s depth of regional experience in running clinical trials in Asia-Pacific, DiaMedica engaged the CRO to help them select a phase I unit and manage the clinical trial in Australia.
Novotech reviewed the proposed protocol and worked with DiaMedica to finalise a number of manufacturing and clinical trial logistic elements. Novotech advised DiaMedica to engage a private phase I unit for the trial, allowing the company to access a private ethics committee and rapid regulatory approval process – saving DiaMedica up to two months in startup time.
Our Actions
Working with the chosen phase I unit, Novotech project managed the trial, and exceeded recruitment targets with over 50 healthy volunteers enrolled. As part of its clinical trial management service, Novotech was also able to provide DiaMedica with access to several high-level IT platforms such as ARGUS, SharePoint, EDC and IMedidata.
Results
Novotech’s DiaMedica team managed the trial from start to finish, providing medical writing and clinical trial management services. Armed with positive data from the trial, DiaMedica was able to expand their product to include a second indication.
“Despite never having undertaken research in the country (Australia) before, we knew undertaking our phase I trial in Australia would be a great opportunity for the company, clinically and financially – but we also knew we would need a regional specialist to access these benefits. Novotech understood both our clinical and business needs and our limitations. They provided clear and insightful guidance at every step. They made it clear from the start they saw themselves as a being our research ‘partner’, not just a service provider.”
DiaMedica, Chief Scientific Officer