Clinical Trial Planning and
Management
Working as an extension of your team, Cliniture provides decades of expertise in clinical trial management to expedite your trials and boost success rates.
We understand that every clinical development program presents distinct challenges, which is why our flexibility and experience supports and tailors solutions to your trial's specific needs. With a global reach, our dedicated team assists all aspects of the clinical trial management process.
We can help you plan an optimal study, designed to collect sufficient data to pass the FDA, Notified Body, or any regulatory authority. And most importantly, we take your budget into consideration.
Why Cliniture?
Focus on Quality
We excel in addressing the intricate details related to your device. We know how to ask the right questions and craft coherent regulatory justifications. Our rigorous internal practices enable us to repeatedly provide high-end deliverables for clients.
Specialists
We understand high standards in regulatory compliance matters. Our team’s biomedical master’s degrees, combined with deep industry know-how and expertise in clinical and regulatory processes allows us to surpass industry expectations.
Service-Orientated
We create a personal bond with our clients. Our service-oriented commitment ensures rapid and accurate responses tailored to our clients’ particular requests, including their tight deadlines, to achieve success.
World-Class Clinical Expertise
The Cliniture team specializes in a wide range of therapeutic areas and fields across medical devices, diagnostics and digital therapeutics (SaMD):
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Aesthetics | Dental | Cardiovascular/interventional cardiology | Orthopedics | Mental health | Women's health | Oncology | Dematology | General surgery | Respiratory | Robotics | Low-risk devices | Absorbable biomaterials
Learning Center
Five Important Concepts to Consider when Writing a Clinical Evaluation Report
Writing a Clinical Evaluation Report (CER) is a complex task. Throughout the process, manufacturers frequently discover that there are more documents and further analysis that they should have prepared. These tasks include fully defining the intended purpose of the device, completing thorough systematic reviews of both the scientific literature for ‘state of the art’ research and ‘pivotal’ (device specific) research as well as comprehensive vigilance database searches. To make life easier, we have created a short list of five essential principles to consider before starting a CER.