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SPONSOR: DERMIPSOR LTD, Israel

STUDY: A multi-center phase II placebo-controlled psoriasis study on 168 patients. (5 recruiting sites)

Study regulatory approval and import license obtaining -- 35 days.
Customs clearance-- less than 24 hours. Study drug distribution from the centrally located warehouse to the sites--24-48 hours.
Enrollment:
To summarize, 168 patients enrolled in less than 6 weeks. Up to date -- three protocol deviations: one subject enrolled with exclusionary laboratory values; one temperature excursion event; four blood specimens lost in transaction.
Sponsor Quality Assurance Audit -- no major findings.
Patient compliance -- as of today no patient drop outs due to non-compliance or due to the informed consent withdrawals.
CRAs -- bilingual CRAs with medical background and knowledge of local health care system and FDA/EMEA requirements.
Sites -- all academic sites approved by the Ministry of Health.

 

WE DO IT ALL AND WE DO IT RIGHT, FROM RECRUITMENT TO RESEARCH TO COMPREHENSIVE SUPPORT SYSTEMS.

STUDY: Preparation begun for the Phase III psoriasis study with expected enrollment of 1,800 patients in 6 countries (USA, Russia, Ukraine, Belarus, Latvia and Bulgaria).
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