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Clinical Trials Management

Complete Clinical Trial Management (CRO) Services

Dedicated, Experienced, Tailored Solutions

Working as an extension of your team, Cliniture harnesses decades of expertise in clinical trial management to expedite your trials and boost success rate. We understand that every clinical development program presents distinct challenges, which is why we provide the flexibility and experience to tailor solutions for your program’s specific needs. With a global reach, our dedicated team works closely with your clinical and regulatory teams to support all aspects of the clinical trial management process. 

Cliniture Clinical Trial Management Services 

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Study Design & Protocol

Cliniture ensures your clinical design and protocol are expertly crafted to meet your trial goals. Our experienced team collaborates closely with you to develop a robust study design and oversees a smooth submission process with the ethics committee (EC) and regulatory bodies. With a focus on optimization and efficiency, we strive to design protocols that yield reliable data and accelerate the path to market approval.

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WORLDWIDE

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Site Recruitment & Management (KOL/PIs)

Leveraging our networks and expertise, Cliniture oversees investigator and site selection, including contract negotiations and Contract Research Organization (CRO) management. We engage with key opinion leaders (KOLs) and principal investigators (PIs), fostering collaborative relationships to expedite site selection and enrolment. By providing ongoing training, high-quality data collection and vendor management expertise, we adhere to timelines and optimize trial performance. 

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Clinical Trial Monitoring and Operations

Cliniture's dedicated team offers comprehensive clinical trial monitoring and operational support. From site initiation to closeout, we monitor visits on-site in Israel and globally (if required), to ensure protocol adherence, data accuracy, and regulatory compliance. We proactively identify and address issues, providing timely resolution and maintaining trial integrity to facilitate successful trial execution.

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Project Management

A poorly managed trial can incur extra costs, This is why Cliniture’s experienced project managers oversee all aspects of your clinical trial to ensure its successful execution within budget and established timelines. With comprehensive project plans, regular status meetings, clear milestones and timelines, our team closely coordinates activities across multidisciplinary teams. Our proactive approach to risk management and communication ensures efficient resource allocation, timely decision-making, and successful project outcomes. 

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Clinical Trial
Documentation

Cliniture assists in the preparation and management of all essential clinical trial documentation. We ensure compliance with relevant guidelines and standards, handling everything from protocol development to regulatory submissions. Our team prepares study documents, including Clinical Study Reports, Case Report Forms (CRF/e-CRF), and Informed Consent Forms (ICF), investigator brochures, and maintains accurate and up-to-date regulatory files throughout the trial. With our expertise in clinical writing, you can navigate regulatory requirements seamlessly and focus on advancing your clinical program.  

Cliniture Clinical Trial Management Leadership

Sharon Goldfarb

Senior Medical Device Consultant

Sharon has over 20 years of experience in Clinical, Quality, and Regulatory Affairs for medical devices. She has successfully managed multi-national clinical studies, secured FDA marketing clearances, and led CE Mark and ISO certifications. Sharon is a certified lead auditor for ISO13485 and has expertise in Medical Device Marcom, IP management, and customer support. Sharon holds a Master’s degree in Regulatory Affairs and a BSc in Life Sciences from Tel Aviv University, Israel.

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Hilla Ben Ezra

Senior Clinical Trial Manager

Hilla Ben Ezra is a highly experienced Senior Clinical Trials Manager with over 16 years of expertise in the medical device field. She has demonstrated success in managing clinical studies globally, from initial design to execution, encompassing phases from First-in-Human (FIH) to post-marketing studies for FDA and CE-approved products. Hilla holds an MA from The Open University and a BA in Sociology & Education from Tel Aviv University, Israel. 

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“We engaged Cliniture's services to revise clinical evaluation documents and develop PMCF and Clinical Development plans for MDR certification. Lihi and her team were highly motivated and dedicated, and were also very proffesional. They demonstrated an open-minded attitude, and excellent communication skills. Importantly, they adhered to the committed due date, ensuring a timely and efficient process.” 
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Malki Epel, VP QA & RA, Taryag Medical

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