Frequently asked questions in clinical research and the biopharmaceutical industry
The project is sponsored by KRC CRO and training services ( http://www.kriger.com/ ) and ClinQua CRO (http://www.clinqua.com/ )Start your Clinical Research Career Now1. the term "Site Management Organization". How do they differ from "Contract Research Organizations?" 2. What is acceptance number 0? 3. how do we calculate about stability, and disintegration time? 4. Is calculate about stability any more cost for investigation of antibiotic drug? 5. How do we connect with "who" 6. I cannot understand the terms ?chemistry-space metrics generated by the software 7. is the typical CRO specialized on certain clinical trial types, is the specialization a foreseeable trend? 8. Is there a way I can get a "hand-on" practice session with MedDRA, or a MedDRA auto-encoding system. 9. While clinical trails are ongoing are the pre-trials being continued at the same time? 10. Does QSR (Quality System Regulations) already replace GMP Good Manufacture Practices officially? 11. Can we consider that piece of vein as a biological device? 12. Can you provide names of some FDA approved ERP software? Who uses it here in Toronto? 13. Can you shed more light on the patent package adopted by Celgene that offered the drug enough protection and presumably made the production of Thalomid profitable? 14. Is it importance to remember these rules like 21 CFR parts i.e. by their numbers and what they relate%2