Clinical Operations-Design to Execution

BayBiotech.NET Conducting clinical trials in developing countries usually are faced with several local challenges and one of them is lack of local Institutional Review Board (IRBs) to review the informed consents and study protocols as well as monitor the study. Mostly, if a clinical trial is initiated outside US, the IRB within United States guides the trial. Mostly, in developing countries maintaining an efficient IRB is considered an extra financial burden on the system. Thus, a US sponsor in a developing country may face the challenges as the views on the judgment about risks and benefits of a trial may differ between the countries. In addition, developing informed consents become a main barrier due to a low literacy rate. Thus, the best solution to this could be that two IRB committees oversee the work, one based in United States as well as one in the developing country. The US sponsor must ensure the existence of such an IRB in the country of interest. The IRB in the country of...

BayBiotech.NET Hello All, Here is a list of some resources related to Clinical Research and Regulatory Affairs, hope you will find them useful for your work! More to follow in my next blog…. Useful Resources 1. Directory of pharmaceutical industry-funded clinical trials, free and easy-to-use interface for patients and health professionals alike to ongoing clinical trials, clinical trial results and complementary information on related issues. Link: http://www.ifpma.org/clinicaltrials 2. Registry of federally and privately supported clinical trials conducted in the United States and around the world. Link: http://www.clinicaltrials.gov 3. Opportunities for public involvement in clinical research: People in Research helps members of the public make contact with organizations that want to actively involve them in clinical research. Link: http://www.peopleinresearch.org 4. Regulatory Affairs Professional Society: society of professionals engaged in r...