Clinical Trial Management
Expedite Your Trials & Boost Success Rates
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.
Our Services
WORLDWIDE
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 protocol in compliance with regulatory requirements. With a focus on optimization and efficiency, we strive to design protocols that yield reliable data and accelerate the path to market approval.
Site Recruitment & Management (KOL/PIs)
Leveraging our networks and expertise, Cliniture manages investigator and site selection, including contract negotiations and Contract Research Organization (CRO) management. We collaborate with key opinion leaders (KOLs) and principal investigators (PIs) to expedite site selection and enrollment. Through ongoing training, high-quality data collection, and vendor management expertise, we adhere to timelines and optimize trial performance.
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.
Project Management
Cliniture's dedicated project managers oversee every aspect of your clinical trial, ensuring it stays on track within budget and established timelines. Through meticulous project planning, regular status meetings, and clear milestones, our team facilitates seamless coordination across multidisciplinary teams. By proactively managing risks and maintaining open communication channels, we optimize resource allocation, facilitate timely decision-making, and drive successful project outcomes.
Clinical Trial Documentation
Cliniture assists in the preparation and management of all essential clinical trial documentation. We ensure compliance with relevant guidelines and standards, writing and handling all the applicable documentation, from protocol development to all submission forms, trial worksheets, and conclusive reports. 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.
Our Leadership
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, including 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.
