Bioequivalence and Bioavailability Forum

Dear all,

I have few doubts and clarifications on BA/BE studies:
1. BA/BE studies are very short term (only few days)..is it worth to do data management with oracle clinical/clintrial/PDS express?-this is consuming lot of time as we have to design the CRFs, design the database etc for months together for the studies which take up just few weeks!
2. What is the industry standards on BA/BE datamanagment systems? does the BA/BE datamanagement needs to be done in the same way as its done in phase II to phase IV studies?
3. Is RDC/EDC systems better for BA/BE data management compared to paper based?
4. Is it a must to medically code Concomitant medications and Adverse events using medical dictionaries in BA/BE studies?
5. How good is openclinica for RDC/EDC for a BA/BE studies. Is it really cheap in the cost (if an enterprise edition is bought) when compared to the costlier clinical data management systems?

Thanks in advance for your valued inputs.
-Mendakki