Emphron Clinical Services for Regulatory Trials
Emphron services for sponsored clinical trials (for regulatory purposes) include:
- Full data management, based on paper CRFs or eCRFs. This service includes the following optional components:
- Generation of the study database, with either paper CRFs or eCRFs. This includes programmed edit checks.
- Generation and maintenance of a data management manual;
- Double data entry and verification;
- Discrepancy checks and query management;
- Medical coding using MEDdra;
- Data exports to SAS.
- Hosted clinical data base services for regulatory studies . We generate and validate a 21CFR11 compliant data base based on paper CRFs (which we can supply) or eCRFs. The data base contains edit checks, and discrepancy management tools. The data base is hosted in our enterprise class data centre, meeting the most stringent security and stability requirements.
- Complete Biostatistical analysis, including study design, protocol review, generation of a statistical analysis plan, randomisation and generation of randomisation enveloped, SAS code and statistical reports. The Emphron Biostatistical quality process can be tuned to meet the needs of individual clients, ranging from an agile standards and test based process through to dual desk independent SAS coding.
All of our services are covered by an established quality process with a comprehensive suite of SOPs.