GEM Programming Solutions

GEM Programming Solutions offers high quality Statistical Programming expertise to the Pharmaceutical and Biotech sector. With over 4 decades of combined service working for AstraZeneca, Directors, Mark and Graham have a wealth of SAS Programming, Leadership, Alliance Management and Clinical Trial experience. Our expertise spans Phase I to IV and submissions in the Oncology, Infection, Inflammation and Respiratory therapy areas. Specialist services:- Leadership of Statistical Programming activities Study level Submission work Regulatory defence Guidance on Quality Assurance framework Independent QC / validation Bid defence, CRO selection and Alliance Management Industry data standards (CDISC SDTM/ADaM) SAS Programming Creation of SAS datasets and TFLs Ad hoc reports Interim Management Support with recruitment activities General statistical programming consultancy Contact us to discuss whether our flexible and efficient service could meet your Programming needs:- Short term fixed contracts e.g. 3 to 12 month contracts to provide experienced programmers to lead programming activities for your drug project(s) Programming consultancy e.g. work with your preferred suppliers programming team to assure quality Deliver discrete pieces of work e.g. deliver programming requirements to support an Interim Analysis