"...About a year ago we began a multi-center, global
clinical trial in 16 countries. Our goal was to randomize 1500 patients by the beginning
of March 2004. We have just met our timeline a month and a half ahead of schedule.
The success of this trial is due in large part to our Russian investigators.
Their success is due in even larger part to EVIDENCE CPR, the CRO that managed the
conduct of the study in Russia... We were very impressed with the professionalism
of the staff assigned to our project... Overall, our experience with EVIDENCE CPR
has been hugely successful and we would not hesitate to work with them on future projects.
We would recommend them highly to prospective clients."
Sincerely,
Silvana R. Giustino
Sr. clinical Study Manager
Atherosclerosis Group, Dual Therapy
Pfizer Pharmaceutical Group
"Dear Dr. Varshavsky,
We would like to thank you for your remarkable work in getting MAGIC
started in Russia and other Eastern European countries that you coordinate...
Since we started collaborating of this project, we have been very impressed by
the skills and experience of the team you lead...The sites you recruited are now
enrolling patients at or above the average rate we expected. We also have been
very impressed by the timeliness and quality of the data entry and data control
procedures... as well as by your understanding of the protocol...
Once again, we at the National Heart, Lung and Blood Institute are very grateful
for all your efforts and are looking forward to a
long and fruitful collaboration."
Very sincerely,
Yves Rosenberg, M.D., M.P.H.
MAGIC Co-Project Officer
Clinical Trials Scientific Research Group
National Heart, Lung and Blood Institute
Michael Domanski, M.D.
Head, Clinical Trials Scientific Research Group
MAGIC Co-Project Officer
National Heart, Lung and Blood Institute
"... The investigator sites selected by CPR/DWCC
(former name of EVIDENCE CPR) "have not only met our expectations regarding patient
recruitment, they have far exceeded them... Furthermore, CPR/DWCC has continued
to play a crucial role in maintaining the enthusiasm of these investigator
sites for this very difficult trial. The Russian centers identified and initiated
for us by CPR/DWCC are among the most highly productive CARISA centers
in the world... . I highly recommend CPR/DWCC for clinical research services
in Russia and Eastern Europe."
Sincerely,
Andrew A. Wolff, M.D., F.A.C.C.
Senior Vice President
Clinical Research and Development
CV Therapeutics, Inc
"... I wanted to take a moment to characterize CV Therapeutics' experience to date
performing Phase 3 clinical trials in Georgia... Specific to Tbilisi, ...
I can assure you than in my 10+ years in the business of clinical research and development,
I have never seen such efforts made BETWEEN centers to identify and screen potential
patients for each other... Both local and international monitors as well as
international their party accredited auditors found the centers in Georgian
to be in complete compliance with CVT protocols, and very well versed in GCP
standards for clinical trials. We would return without a moment's hesitation
to any of the Georgian centers included in our study."
With Kindest Regards,
Rafael Escandon, Ph.D., MSc
Director, Clinical Operations
CV Therapeutics, Inc
"...Over the past year, New England Research Institutes (NERI)
has been working with CPR Institute/DW Coordinating Center on the MAGIC
(Magnesium in Coronaries Trial in Russia, Latvia, Ukraine, Bulgaria, Slovakia and Georgia
. MAGIC is a 10,500 patient worldwide multinational
study sponsored by the National Institutes of Health.
Professor Antman of Harvard University is the study Chairman.
CPR/DWCC has provided NERI with about 100 quality sites.
They also operate a central pharmacy in St. Petersburg to distribute drug throughout
the Russian Federation... CPR/DWCC has not only met our expectations regarding
site and patient recruitment, they have far exceeded them.
They have played a crucial role in maintaining enthusiasm in a challenging trial
and are the highest recruiters... I would not hesitate to use this organization again,
and would highly recommend them for clinical research services
in Russia and Eastern Europe."
Sincerely,
Sonja McKinlay, Ph.D.
President
NERI
"...CPR/DWCC has provided The Medicines Company with 86 quality sites (for the HERO-2 study).
They also operate a central pharmacy in St. Petersburg to distribute drug throughout
Russian Federation. Storage and shipment of the study drug require special conditions: +2 - +8
degrees Celsius. The pharmacy has passed several independent GCP audits by AAC Consulting
Group of Bethesda, MD. The auditors are former FDA inspectors.
The same group has also audited clinical sites and the CPR offices in St. Petersburg.
Overall, CPR/DWCC has not only met our expectation regarding site and patient recruitment,
they have exceeded them. They are the highest recruiters among all Regional Coordinating
Centers... I would not hesitate to use this organization again, and would highly
recommend them for clinical research services in the former
Russian Federation countries."
Sincerely,
Ian D. Fier, BS, MBA
Sr. Director, Product Development
The Medicines Company
