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Your Partner for 
Clinical and Regulatory Excellence

As specialists in the field, we help healthcare companies successfully navigate the complexities of clinical and regulatory compliance.

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.

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Working with Financial Documents
  • Study design & protocol

  • Site recruitment & management (KOL/PIs)

  • Clinical trial monitoring and operations

  • Project management

  • Clinical trial documentation

Learn More

Why Cliniture?

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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.

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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.

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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.

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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):

Aesthetics  |  Dental  |  Cardiovascular/interventional cardiology  |  Orthopedics  |  Mental health |  Women's health  |  Oncology  |  Dematology  General surgery  |  Respiratory  |  Robotics  |  Low-risk devices  |  Absorbable biomaterials

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We are Trusted by Leading Companies

As a demonstration of our service quality, we are trusted by great customers as follows.

"I had the pleasure of working closely with Cliniture on multiple challenging projects. Lihi’s exceptional problem-solving skills and strong attention to detail were instrumental in the success.

I highly recommend Lihi, Victoria, and the Cliniture team members for their exceptional attention to customer needs, dedication, professionalism, and ability to deliver results. Their capacity to understand and anticipate customer requirements was key to delivering outstanding service."

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Natalie Dror, Clinical Affairs Manager, Alma Lasers 

Learning Center | clinitrue

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.

Five Important Concepts to Consider when Writing a Clinical Evaluation Report
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