|

TODAY
IN PHARMAEGDE RESEARCH,
INC

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.
|
|
|
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).
|