ORION Clinical Services | Services | Biometrics






-	clinical research & project management
-	clinical development planning
-	regulatory affairs
-	medical writing
-	quality assurance
-	pharmacovigilance
-	biometrics
	- data management
-	- statistics


Services \| Biometrics \| Statistics Our dedicated team of Senior Statisticians, Statisticians and SAS programmers work in close collaboration with the Data Management, Clinical Research, Medical Writing and Project Management teams. They work to our own in-house procedures or to the sponsor’s SOPs in full conformity with ICH. Their experience covers diverse therapeutic indications and Phases I to IV. ORION’s system is a dedicated Windows NT network, which operates with PCs using SAS. Our services include: Statistical consultation Sample size calculations Preparation of the statistical sections of protocols Preparation of randomisation lists and central randomisation Preparation of Statistical Analyses Plans Programming for statistical analyses Generation of figures, tables, appendices and listings Preparation of data transfers according to client needs including full quality assurance Preparation of the statistical sections of clinical study reports Our internal Quality Assurance Department regularly audits the Biometrics Department in the context of both System and Project related audits.