Clinical trials are about bringing safe medicines to patients in need, and apart from trial management issues, the medical monitoring of the study is of paramount importance. Centralized Medical Monitoring centers can be established, but again it comes down to the people on the ground that are not always familiar with the Sponsor's standards of narrative writing and reporting.

National health legislation in Central & Eastern Europe can significantly vary from the standards accepted in North America and Western Europe. Some of the issues that are often multiplied when the study is in multiple countries are:

• Language differences
• Medication coding
• Country specific report submission requirements
• Adequate training on protocol specific medical monitoring procedures

S&P Pharmaterra's experience in Medical Monitoring is unmatched. We closely work with every Investigator, provide all necessary help, training/retraining, and translations of writings if needed. We enforce proper SAE/SUSAR reporting and follow up procedures, compliance to protocol, violation tracking and reporting.