Direct management of the trial, from design to regulatory submissions.
The clinical trial: evaluating the effectiveness and safety of the device on humans.
Centaur Clinical has a team with expertise in clinical operations and regulatory affairs, which can assist the MD/IVD manufacturer from trial design through to the preparation and drafting of regulatory dossiers and their submission to the notified bodies. The team’s multilingual profile and the partnerships with CROs around the world ensure coverage of the clinical operations in almost every corner of the globe. The team’s multilingual profile and numerous partnerships with CROs around the world ensure that trials are covered in almost every corner of the globe. In addition, its knowledge of FDA and other countries regulations means that the relevant criteria for future extensions in the desired countries can be incorporated right from the outset.
• A clinical trial can compensate people who participate in the study as healthy volunteers.
• The study may or may not have a placebo as a control.
• It can be:
Open-label: everyone knows who gets what product.
Blind: the patient does not know what he or she is receiving but the investigator (hospital or medical site) has the information.
Double blind: neither the patient nor the investigator knows who receives what.
Have a system of randomisation: patients are chosen at random.