Clinical Trial Data Services (CTDS) is a specialized clinical research organization with specific and focused expertise in data management, statistical analysis and medical writing services for clinical trials. CTDS helps medical device, biotech and pharmaceutical companies move from research through the clinical trial process. Regardless of study size or scope, we provide customized solutions that produce quality data suitable for FDA submission and regulatory rigor and scrutiny. We have many years of experience helping companies improve clinical trial processes, optimize resources and achieve compliance. By working with CTDS, you can decrease costs, improve data quality and assure data integrity for every trial. We offer comprehensive, customized solutions covering a broad range of therapeutic areas and types of clinical studies. Our service areas include: •Study Design – We investigate appropriate clinical trial designs and perform sample size calculations. •Clinical Services – We provide CEC/DSMB facilitation. •Database Development – We design database solutions specifically for your study •Data Management – We collect, clean and code clinical data to ensure data integrity and quality •Statistical Programming – Our team performs statistical analysis and reporting based on protocol-specified endpoints. Generation of SDTM and ADaM datasets is also performed •Statistical Consulting – Generation of SAPs, determination of which statistical analyses to use, input into CSR, FDA representation