Questions and Answers

From agreement of the proposal and our master service agreement, it takes 24 hours to execute the contract and for Mobius to commence work.
Yes, all initial contact is with a Mobius Medical Principal and we will ensure the proposal and contractual agreements are as painless as possible so that we can start assisting you. Sometimes one of the owners will work on your project for the duration, or we will oversee one of our amazing project managers or SCRAs as they take the lead for your study.
Yes, it really is. The Australian regulator is Therapeutic Goods Administration. There are two mechanisms for the legal supply of therapeutic goods in a clinical trial setting – notification and approval. Almost all trials will be eligible for the notification pathway allowing the ethics committee and the institutional approval to be the gatekeepers. See the Australian Clinical Trial Handbook
The CTN is submitted to the TGA online by the local sponsor (Mobius, if an overseas sponsor does not have a legal entity in Australia) and, once submitted and paid for, the legal supply of unapproved product in a clinical trial can proceed.
The local sponsor (Mobius, if a sponsor does not have a legal entity in Australia) will assess the IP for requirement of a BICON (Biosecurity Import Conditions) permit (allow 2-3 weeks). This, along with the CTN submission evidence is all that is required (in addition to the commercial invoice).
In Australia and New Zealand, the average time for a site to receive approval for a new study is approximately 12 weeks.
Yes, but there are a number of steps before a hospital will permit this. Overseas qualified practitioners may require AHPRA registration a visa and apply to be credentialed by individual hospital administrations.. Sponsor support staff may be permitted entry to cath. labs etc in Australian and New Zealand hospitals, provided they do not provide medical advice, but pre-approval is required. Presently, there are also strict visitor entry requirements due to COVID .
No, to access this scheme, an overseas Sponsor must have a local Australian entity in the role of sponsor, funding the research. Clinical trials conducted in Australia are fully eligible for this scheme which can attract a cash rebate of over 40c in the dollar.
The guidance that directs all activity is the NHMRC National Statement on Ethical Conduct in Human Research. This, along with ICH GCP and ISO14155 ensure our compliance to global requirements.
Yes, Mobius has experience in clinical trials that involve use of a new medicine requiring Standing Committee on Therapeutic Trials (SCOTT) approval. This is usually a parallel process to the ethical review for clinical trials.
No, medical device trials are not regulated in New Zealand. Medsafe, the regulatory body encourage sponsors to notify them of new research but approval for sponsored clinical trials lies with the ethics committees and district health board (for institutional approval).
Yes, Mobius has been, and is currently involved in, FDA trials as well as trials for CE Mark.
Yes, we do, and access is provided to as many users (with restrictions per role) as required.
Yes, we do. Our EDC has great features for ePRO and at home e-diary completion allowing for hybrid and decentralised clinical trials.
Indeed it does, this feature is easy to set-up and we’ve received ethics approval for decentralised trials.
Mobius carefully discusses clinical case load and encourages honest estimates from investigators at site qualification visits. In addition, we offer specialist recruitment services using the correct balance of different media advertising (radio, posters, social media campaigns) and tracking of interest, pre-screening and screening activity.

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