Feasibility Assessment and Site Selection
Our well established relationships with clinical investigators as well as centers of academic excellence contribute to our large pool of potential Investigators. Our local expertise, and our investigator selection result in a very accurate feasibility assessment.
Site selection is our specialty, we can identify the right site for the right project based on infrastructure and previous performance.
Each country has its local regulatory process. Our local expertise with the regulatory authorities enables us to process all requirements efficiently. We partner with local depots and experienced logistic storage and distribution facilities.
We manage the monitoring and reporting of the quality and safety of Phase II-IV clinical trials. We ensure compliance with regulatory authorities on safety reporting and GCP requirements. Furthermore, we offer continuous correspondence with regulatory authorities, regulatory document tracking, collection, reviewing, filing and maintenance of the study master file.
Monitoring of Clinical Trials
Smart Science performs clinical trial monitoring in accordance with ICH GCP guidelines to ensure that the rights and well-being of human subjects are protected. This also guarantees that the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s) and applicable regulatory requirements.
We provide experienced monitors who are well trained and highly efficient. Our monitors receive continuous education and training, and they receive full support on logistics from our main office. We provide the number of experienced monitors based on the size of the project.
Project management is of utmost important to us as it is the key to maintaining a smooth flow throughout the conduct of the study. Our experienced project managers work in a timely fashion and with strict budget controls. They focus on careful planning and giving high priority to each trial, they collaborate with the sponsor in every step.
We provide logistic services for clinical trials through our close partners and dedicated team. We can facilitate import license, custom clearance, storage services (2-8, 15-25 degrees), and distribution to sites.
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