Study teams and sites want more with less: more patient information, more clinical insight, and more control, and less system complexity and burden.
This is what we deliver with Clinical One—the most advanced eClinical platform, built from experience, to support the most complex trials in the simplest, most user-friendly way. Clinical One changes the way clinical research is done, empowering you to
think and
act differently.
Welcome to Clinical One. Welcome to the future of clinical trials.
Medical device manufacturers and device clinical trials face unique challenges compared to their pharmaceutical counterparts, which includes (but is not limited to):
- Less experience in running clinical trials, and the need has been accelerated by the regulatory changes over the last few years
- A device’s safety and effectiveness functions facilitate a clinical outcome that is a combination of the professional user’s competency operating in parallel with the patient-device interaction
- The device design or procedure may be modified during the trial based on feedback from physicians or patients, and often many device trials assess iterative improvements on previous-generation devices
- Use of placebo’s. blinding or randomization is impractical owing to the nature of the device or the condition under study
- Manufacturers are required to report all SAEs, even if they are not directly related to the device or the procedure in which the device is used
Join us to see how Clinical One can
optimise operations for Device Manufacturers and Clinical Research Organisations to design, and manage device clinical trials from pre-market analysis to post-market follow-up.
