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REGULATORY ISSUES IN U.S. & OVERSEAS



US Branch strictly follows FDA Regulations:

• Focused on the details, objectives and outcome
• Full compliance to the GCP and strictly following SOPs
• Demonstrated service and commitment to quality, accuracy and time
• Locally available well reputed IRBs as well as use of centralized IRB reasonably
• Innovative leadership
• Selection of well experienced, dynamic and knowledgeable principal investigator
• Well trained study coordinators to the sites selected by ASI-CRO
• We have great experience and knowledge of site selection for maximum and accelerated recruitment of subjects
• Well organized investigators meeting
• Commitment to employee growth and retention
• Comprehensive training & development
• Great communication and ease of access to the clinical study staff 24/7
• We have proven to be effective liaison between our client and the Food and Drug Administration

CLINICAL TRIAL OVERSEAS:

ICH-GCP guided related services provided globally…

• Strategic planning & communication; we speak your language
• Global scale, Universal Standard
• In-depth, global experience
• Regulation guidance and compliance with international requirements
• Interface with regulatory authorities internationally, for fast approval of study protocol
• Locally available US trained energetic clinical research associates for accurate monitoring services
• On schedule submission of study results electronically
• Centralized labs experienced in clinical trials with electronic data capture through LIMS
• Protocol design in coordination with Physicians and Statisticians