In the period from 2011 to 2012, we received the follow audits :

• DAICHII SANKYO PHARMA DEVELOPMENT
  Audit for the Phase 1b/2 study Protocol No. U31287-A-U202 “A randomized, placebo-controlled double blind phase 1b/2 of U3-1287 (AMG 888) in combination with trastuzumab plus paclitaxel in metastatic breast cancer (MBC ) of newly diagnosed HER2 positive."
• DEPARTMENT OF PHARMACOLOGY, NATIONAL INSTITUTION OF MEDICINE, A.N.M.A.T.
  Inspection for BioAnalytical Laboratory- Protocol Codes: 1700- 1300- 1301- 1400- 0210 and 0211.
• RICHMOND LABORATORIES
  Audit of BioAnalytical Laboratory for Protocol Codes: 0209- 0210- 0211 and 0212.
• INDEPEDENT ETHICS COMMITTEE
  Audit for Protocol Codes 1700 and 1300

Internal Audits

• F.P. Clinical Pharma established an Annual Plan of Internal Audits of the Quality Management System and Good ClinicalPractices.
• Intense audit activity from our clients, both domestically and abroad, guarantees the quality and reliability of our work and our facilities. Over 10 pre and post study audits affirm our excellence.

Monitoring

• We collaborate with monitors.
• We understand that by being monitored by the sponsor is essential to ensure the quality of our investigation, which is why our clinical team is dedicated to actively cooperating with the monitors.
• Along with the Study Coordinator, a Medical Investigator always welcomes the monitor and acquiesces to his/her requirements.
• We have a pleasant work area for the monitors, fully equipped to satisfy their needs.