Medical device trialsMedical device trials share many characteristics with biopharma trials, but have important differences including shorter timeframes, smaller subject groups, procedure training, and continuous product innovation (adaptive trials). BELTAS has undertaken many device studies on behalf of companies ranging from start-ups to large international firms. It is one of just a handful of CRO's around the world, which manages a substantial number of medical device studies. Currently New Zealand has a particular advantage for device trials, as these do not require regulatory authority (Medsafe) approval. Ethics Committee (IRB) approval for device trials is required. BELTAS notifies the local regulatory authority and reports six-monthly safety data. New Zealand and Australian sites run trials of devices in areas including interventional cardiology, diabetes, respiratory, orthopaedics and urology. BELTAS has managed a number of medical device trials in European centres under the EU Directive, and companies have found our European/Australasian experience in devices helpful in advancing their device development programs. Medical Device Development: US and EU Differences
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"Contract research organizations (CROs) provide substantial global capacity to drug developers and have become a critical contributor to clinical trial activity" - Tufts CSDD |
