Medical Device / Pharma / Advanced Therapies
Two approval pathways: Special trials (hospital-level) and Non-special trials (Ministry of Health).
Arranging the submission dossier, collecting investigator documents (CVs, diplomas, GCP certificates), and managing translation of all patient-related materials to Hebrew, Russian and Arabic.
PI submits the application to the institutional Helsinki Committee for ethical review and approval.
Agreements with study sites and investigators done in parallel to the regulatory approval process.
Obtaining import permit for investigational products.
The site uploads the study to the Israeli Ministry of Health.
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Our team will guide you through every step of the process.
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