A. Stein Regulatory Affairs Consulting provides professional support in the planning and management of clinical trials, including feasibility and pivotal clinical trials, as well as Human Factors and Usability Engineering Studies. Our team has extensive experience in:
Clinical Study Protocol Development and IRB Submissions
Study documentation, Site location, Contract and Budget Negotiations, Site Initiation Visits (SIV)
Electronic Case Report Form development
Risk-Based Monitoring Plan, On-site, Off-site & Centralized Monitoring
Clinical data analysis according to a Statistical Analysis Plan (SAP)
Results and conclusions of the clinical study
A. Stein Regulatory Affairs Consulting’s experience covers numerous multicenter studies over the US, Europe and Israel, with hundreds of subjects and more than 15 sites for regulatory submissions, in the medical fields of mental disorders (MDD, OCD, etc.), Cardiovascular (IVC Filter), Aesthetic treatments (circumferential reduction, wrinkles, acne, etc.), AI Software Diagnostic devices (Diabetic Retinopathy, Stent placement, etc.), Orthopedics (robotic navigation of tools/implants), Erectile Dysfunction (thermal treatment), bladder cancer (hyperthermia combined with chemotherapy), breast cancer (early detection) and more. Furthermore, we have overseen numerous FDA BIMO audits of clinical studies with consistently successful outcomes.
Let’s discuss how we can accelerate your path to global market access with clarity, efficiency, and consistent compliance.
Contact A. Stein Regulatory Affairs Consulting Ltd.
Address: 18 Hata’as St. Kfar Saba, ISRAEL , 4442518.
Phone: +972-9-767-0002
Email: office@asteinrac.com