Services Offered: 

Medical device services, Clinical Trial Management, Regulatory Consulting, Site Management, Feasibility regulatory interaction – FDA/ICH/EMA and advice (including CDISC integration), SOP writing services, training courses, process improvement, statistical support on-site, sample size calculations, randomization, protocol / clinical investigational plan development and clinical study planning, statistical analysis plan (SAP), presentations of study design to regulatory agencies, (blind) data review meeting, inferential analysis, pharmacokinetic services, generation of summary tables, figures and listings with SAS, CDISC (SDTM / ADaM / define.xml), updating historic study data to CDISC standards., development of Data Monitoring Committee charters and timely interim data reports. statistical report – ICHE3 compliant and CSR ready, comprehensive support for Clinical Study Report Writing, contribution to publications arising from the study results, integrated summaries (ISS, ISE) and regulatory dossiers (NDA/PMA submissions), Site Selection, Study Start Up, Project Management, Clinical Monitoring, Vendor Management, Data Management, Biostatistics, Pharmacovigilance, Medical Monitoring, Medical Writing, Quality, Legal Representation, Regulatory Services, Consulting Services, Technology, Flexible Resourcing, BIOSTATISTICS, DATA MANAGEMENT