Phase I (Early Phase)           Early phase studies involve the careful assessment of preclinical information obtained to design First-in-man study to assess safety and tolerability in human. We offer comprehensive early phase services by translating the pre clinical data into the well planned and executed phase I study.           Phase I (study services)     First-in-human Proof of concept studies PK/PD studies Micro Dosing Biomarkers Dose escalation studies           Phase II to IV (including NIS & PMS trials)     Clinical Plan Development Project management Teleconferences Project meeting Organizing investigator meeting Communication with sponsor/Investigator Tracking Regulatory documentation Distribution & tracking of IND safety reports EDC – trials (MARVIN System / 21 part 11)   Site Feasibility & Investigator Selection Database of Experienced Investigators Wide Geographic Distribution Site contract and budget negotiations IRB Submissions Trial Master File Maintenance Investigator Meeting Coordination and Conduct Site Training & Management Site monitoring/In house monitoring Site identification, qualification & initiation Site personnel training Site close out Drug accountability Source data verification