Lihi Levin
How long does it take to write a clinical evaluation report (CER)?
Recently, as Israel resumed normal operations, someone asked me, "What is the typical duration for composing a clinical evaluation report...
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About us
Helping You Successfully Navigate
Clinical and Regulatory Compliance
At Cliniture, we specialize in expert clinical and regulatory writing and clinical trial management services for medical manufacturers to help boost regulatory compliance and trial success. With a seasoned team holding biomedical backgrounds combined with industry expertise, we are dedicated to delivering timely, cost-effective solutions that uphold the highest quality standards in clinical-regulatory documentation.
The Challenge
Remaining updated on clinical and regulatory changes is critical but complex. Notified Bodies rigorously oversee clinical and regulatory records, demanding industry expertise for quality delivery.
Under FDA requirements and the new Medical Device Regulation (MDR), manufacturers must meticulously search, analyze, and adhere to current evidence and guidelines, necessitating attention to detail, expert knowledge and understanding of past lessons learned.
With our full range of clinical writing and clinical trial management services, Cliniture was founded to help manufacturers overcome these challenges
Our Approach
At Cliniture, we work hand in hand with our clients to achieve the shared goals of project success, high-quality clinical evidence and regulatory compliance. Our dedicated professionals help you navigate the intricate landscape of clinical and regulatory requirements to ensure the delivery of high-quality work. Serving as an extension of your team, we prioritize accuracy, dedication, and efficiency in all that we do.
By harnessing your existing data and fostering innovative thinking, we work with you to uncover the most low-risk and cost-effective solutions. Driven by a passion for excellence, we are steadfast in our commitment to delivering exceptional results.
Our Founder & CEO
Lihi Levin, MSc
With nearly a decade of experience in clinical writing and scientific research, including MDR clinical-regulatory documentation, scientific articles, and literature reviews, Lihi is a seasoned expert in the field. Founding the Cliniture group four years ago, Lihi has been dedicated to addressing the clinical-regulatory strategy and writing needs of healthcare companies and entrepreneurs in light of the new EU MDR changes.
She has written over 50 Clinical Evaluation Reports across diverse medical specialties such as radiology, dentistry, aesthetics, mental health, and minimal invasive
Our Resources
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