A singular focus on clinical research With 20 years of continuous operations dedicated to clinical trials, you can trust us to expertly design and manage your most complex study. Our study experience includes both domestic and international trials. We offer a full range of integrated and customized clinical trial services. Project Management including project feasibility, study budget and timeline management, study tracking reports, risk assessment and mitigation and vendor management. Clinical Operations including feasibility & site / investigator selection, study start-up, regulatory document collection, IRB submission, TMF set-up and maintenance, clinical monitoring, and site management. Study Design & Medical Writing including protocol writing and review / optimization, clinical study report, ISS/ISE, Marketing Approval Applications (MAA) and New Drug Applications (NDA). Data Management & Biostatistics including sample size determination, randomization schedules, statistical analysis plan development, DSMB/DMC establishment and management, TLF programming, and data analysis