Pharmaceuticals - Wilmington, North Carolina, United States
DFS Pharma supports pharmaceutical, biotech, medical device and animal health clients with affordable cloud-based EDC database builds and full service, expert Data Management support. Highly experienced and proactive senior-level and director-level Data Management staff can support you within your preferred development model. - Performing full study database builds in affordable EDC cloud-based systems: we can create specifications, build the study, test the study and create the release documentation or a hybrid where you perform what you want and we do the rest. - Provide expert training to you and your database users - Work with you to standardize your data (i.e. CDISC CDASH or SDTM) - Integrate external data sources (core labs and safety systems) - Perform Medical Coding - Create your Data Management Plan - Program listings for manual data review - Program external data reconciliation listings - Review your data; generate and address data queries in EDC - Provide standard metrics We also have seamless partnerships to provide full Biostatistics and Statistical Programming support including: - SAP creation or review - Programming and QC of TLFs - SDTM dataset creation - ADaM dataset creation - ISS and ISE creation We stand out from the crowd. Our goal is not only to provide the highest level DM and statistical support but a great team experience and forthright expectations. We have decades of experience from the sponsor side and are intent on improving/re-inventing the sponsor/consultant dynamic.