Clinical Operations-Design to Execution

BayBiotech.NET When ICH was conceived in 1999, it was for a good cause understanding that it will have harmonization on guidelines for conduct of a clinical trial worldwide as it brought together European Union, United States and Japanese experts together to draw a set of standards that would streamline the clinical research globally. Out of thirty-eight topics (Guidelines) originally identified, only the ICH E6 document relates to the standards of Good Clinical Practice. Since, the EU Directive were set in place for conducting a clinical trial in UK and European member states it is not only ICH E6 but also EU GCP Directive 2001/20 and 2005/28 that is required to be followed which gives a higher standard than ICH E6 alone. Apart from these directives, member states of the European States have their local laws that are also incorporated into the GCP conducts. This further complicates the conduct of clinical trials and acceptance of global data because if a member state selects a site...

BayBiotech.NET Performing site visits to your CROs for compliance audits at certain time intervals ensures the integrity and quality of data you are receiving for the clinical research. Sponsor audits also set stage for engaged CROs to prepare for direct FDA audits and leads to increased chances of success. Audits may be either routine audits to check the facilities for compliance or may be based on the performance or any non-compliance issue that may have come in the highlight during the course of the study. In either case an audit provides CROs with timely opportunity to take corrective and preventive action measures and makes the CRO facility aware of sponsor’s vigilance leading to compliance on their part as well as best outcomes of financial investment for the sponsor. Before performing an audit, an audit plan must be drafted by the auditor specifically preparing a check list of the items or issues that are recognized as critical steps of the procedures performed at CRO sites....